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Genevolve to Launch Military Grade DNA Test for Color Blindness

The breakthrough genetic test designed to meet FAA and US Air Force requirements is set for release at the Aerospace Medical Association in May.

Genevolve Vision Diagnostics is launching its military grade genetic test for all major forms of congenital color blindness at the Aerospace Medical Association annual event May 13th-15th in Atlanta, Georgia. It is the first totally objective color vision test that can consistently separate colorblind individuals from those with normal color vision and accurately classify color vision deficiencies. As such, it offers a solution to the problem of setting uniform standards in the workplace and meets the color vision testing requirements of militaries and government organizations grappling with badly outdated testing methods. “The new military grade test is near perfect at separating color normal’s from color defectives which has proved challenging with conventional testing methods,” said Genevolve president Matt Lemelin. The genetic test, and much of what is known about color vision itself, represents decades of research by the husband and wife team of Jay and Maureen Neitz, PhD., who are both professors of Ophthalmology, and Biological Structure at the University of Washington.

Color blindness is the most common genetic disorder in humans, affecting more than 250 million worldwide and over 100 occupations are considered color critical. A significant improvement over conventional color vision tests is the ability of the genetic test to rate the severity of the highly variable condition on a scale of 1 to 100. “This prevents a qualified applicant from being denied entry into a field they can adequately perform and eliminates cheating or administrator bias that may allow some severely colorblinds to slip through the system,” says Lemelin. The test has been designed to meet the needs of the Federal Aviation Administration and the U.S. Air Force as the departments and others have been critical of the failure of color vision tests currently on the market meeting their requirements. Highlighting testing failures and prompting the National Travel Safety Bureau to recommend new color vision testing standards was the 1997 Amtrak train disaster blamed on a colorblind engineer that misread colored signals and the 2002 Fed Ex plane crash labeling the 1st officer’s undetected colorblindness as a contributing factor.

The military grade test, marketed under the Eyedox™ brand, involves a painless finger prick to obtain a blood sample which is specifically analyzed using gene sequencing technology to analyze the color genes, which are expressed in the eye but present in all cells, to give both a precise identification and an accurate classification of any inherited color vision deficiency along with a precise severity rating. There is significant cost savings as the new technology eliminates the need for repetitive testing and expensive travel to testing sites. Further cost savings can be found, although more difficult to quantify, in improved safety, enhanced job performance and accident avoidance. The genetic test is anticipated, on average, to accept as safe to perform, 30% of applicants currently excluded on the basis of conventional color vision tests which can result in bolstering ranks and preventing unfair discrimination.

“This is a major breakthrough because scientists strive to understand the genetic basis of human disease, it is often more important to forecast the severity of the impairment than to merely reveal the presence of a genetic defect,” said Dr. Jay Neitz.

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Looking for that sweet spot to get market traction

By Francis Moran and Leo Valiquette

This is the fourth article in a continuing monthly series chronicling the growth path of Genevolve Vision Diagnostics, a life sciences startup based in Albuquerque, NM that is commercializing cutting edge genetic research to develop new diagnostic tests and gene therapies for colour blindness.

Sometimes, you need to take a step back to get two steps ahead.

In the almost two months since we last touched base with Matt Lemelin, CEO of Genevolve Vision Diagnostics, this has certainly proven to be the case.

Genevolve was planning to make a big splash at the annual meeting of the American Academy for Pediatric Ophthalmology and Strabismus this month. An impressive showing here could spark the endorsement and early adoption from the broader medical community Genevolve needs to kick start the process for qualifying its Eyedox Genetic Test for Color Vision for insurance reimbursement. However, Lemelin decided to pull out of the show and refocus on the largest industry show of the year – the annual meeting of the American Academy of Ophthalmology taking place in Chicago in November.

“The stars are not aligning as planned for our launch,” he said. “We have had delays on the science side. A major challenge lies in, for a lack of a better word ‘transferring’ the test collateral from the research side to a commercial entity so that it works flawlessly. This has turned out to be quite a challenge. It is imperative to release a perfect product to preserve our reputation.”

There is a substantial market demand

It is a reputation that is still in the early stages of being established in the marketplace. Genevolve was founded in 2009 to commercialize non-invasive molecular diagnostic assays and treatments for clinical applications in the colour vision industry. Eyedox is the company’s first commercial product – a genetic test that can diagnose colour blindness in a far more accurate and thorough manner than existing tests, such as the century-old Ishihara test.

A growing number of daily activities and professions rely on normal colour vision and on accurate diagnosis of the presence and severity of any colour vision deficiency. However, traditional tests often cannot provide a proper diagnosis in terms of the type and severity of a deficiency, and often result in misdiagnosis.

“Over the years, we have received emails, calls and letters from thousands of frustrated colour-blind people,” Lemelin said. “The outcry from patients, together with feedback from practicing clinicians who have indicated that a genetic test will change everything for them, motivated us to develop the test as a commercial product.”

With its genetic test, Genevolve is blazing a new trail to create a global colour vision standard for all occupations. But this is a risky proposition at a time when investors remain wary of life sciences investments into new areas of research and the complex U.S. system for health insurance reimbursement is facing an overhaul.

Last month, Lemelin pitched Genevolve at a Gathering of Angels event in Atlanta. Inevitably, the issue of insurance reimbursement came up. But like every savvy entrepreneur hustling for cash, he understands the need to be ready for hard-nosed questions from potential investors.

“I suggest that entrepreneurs seeking investment be prepared for anything and have canned answers at the ready, especially if issues are presented at inopportune times,” he said. “I came away with some good leads and learned lots to add to my arsenal of knowledge.”

Among those lessons learned, which we will explore in more detail in our next post: how to better present to angel investors, how to negotiate with investors over the valuation of your company, and trying to make progress at industry gatherings where the social aspects appear to overtake the business agenda.

But it all comes back to reimbursement …

In our last post, we talked about how Genevolve’s colour-vision test falls into the category of molecular diagnostics, which can qualify for reimbursement through a complex pricing and fee schedule that uses “stacked codes.” These codes are used to tally up the costs associated with each step that is required to carry out the test, as well as the technology involved. A new test must go through a long and complex process to have new codes created and qualify for long-term insurance reimbursement.

Genevolve believes its Eyedox test can also save doctors time, by a factor of 10. While anything that saves time is a plus, the challenge is how doctors are compensated for their time and how this is claimed for insurance reimbursement.

At present, doctors are only able to bill the U.S. insurance system for their time if they are able to diagnose the type of colour blindness. Due to the limitations of standard tests, they seldom can. As a result, many doctors shy away from carrying out colour vision tests or see it as a loss that they write off. Not only must Genevolve attempt to execute a culture change in how doctors regard colour vision testing, it must still determine if doctors who use its test are able to make an insurance claim using existing codes.

Casting a shadow over all of this is U.S. President Barrack Obama’s new health care plan, which threatens to tighten the rules governing what qualifies for insurance reimbursement, the uncertainty of an election year and a new tax on medical devices intended to help extend health insurance coverage to uninsured Americans.

“All of this has a ripple effect on innovation and trickles all the way down to creating considerable investor angst,” Lemelin said. “Nobody, even the big boys, can figure out the reimbursement changes, many variables and many unknowns. It is causing many to sit in the sidelines, stifling innovation.”

… and developing contingency plans

One of the challenges for Genevolve is to design its test in such a way that it becomes easier for physicians to derive revenue from carrying out colour-vision testing, either by being able to bill the insurer or the patient. With changes to the U.S. medicare system, Lemelin said physicians are looking for new lines of business. Genevolve hopes to tap into this by bundling its test with other related vision products and services that are not billable to the insurer, such as contact lens prescriptions. In other words, make the colour vision test part of a service that the patient is already accustomed to paying for and is already a source of revenue for the physician.

Genevolve also has a contingency plan up its sleeve if it doesn’t qualify for reimbursement.

“We would switch to a boutique model in which we would then compensate doctors,” Lemelin said. “But, realistically speaking, we would need to take a volume approach and bring our price way down to make this model successful. There is a fine line here as far as losing our shirt, but we feel we can make it work as a last resort.”

Another option that Lemelin is considering is a group purchasing organization, or GPO, involving early adopter physicians and possibly partnerships with other vendors of vision products. The incentive for physicians to sign up would be that they would have exclusive access to unique products.

“It’s just an idea,” Lemelin said. “It is critical to evaluate all options … they all have their pros and cons. You have just got to somehow find the sweet spot and unfortunately there are so many unknowns that some of it is wait and see and shifting on the fly.”

Next time, we’ll talk about the pros, cons and complexities of wooing angel investors.

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Dealing with the devilish details

By Francis Moran and Leo Valiquette

This is the third article in a continuing monthly series chronicling the growth path of Genevolve Vision Diagnostics, a life sciences startup based in Albuquerque, NM that is commercializing cutting edge genetic research to develop new diagnostic tests and gene therapies for colour blindness.

According to Matt Lemelin, CEO of Genevolve Vision Diagnostics, there are more than 100 occupations which rely on workers having normal colour vision. As we explored in our last post, civilian and military aviation, where there is no room for error, ranks high on this list. Job performance and passenger safety depends on pilots, air traffic controllers and many other technical and support personnel having full colour vision.

It’s easy to understand, then, why Lemelin is filled with such enthusiasm for Genevolve’s prospects when he hears the United States Air Force state that “no colour vision test currently on the market delivers what the Air Force requires.”

“We are very excited about the possibilities of working with the Air Force and other governmental departments,” he said. “We have a fairly complete understanding of their needs in regards to colour vision and we feel we have a turnkey solution to resolve their longstanding issues.”

The challenge, of course, is to bring to market a compelling product that is protected by a rigorous intellectual property (IP) strategy and has garnered the regulatory approvals and industry praise to attract the interest of such a flagship customer. In this post, we will take a look at Genevolve’s product development, IP strategy, business plan and how venture capital does, or does not, fit into the picture.

Finding the right partner … and the right terms

While the ground-breaking genetic research that underpins Genevolve’s value proposition is ultimately intended to treat colour blindness on a commercial scale, the company is first bringing to market the Eyedox Genetic Test for Color Vision – a first step toward creating a global colour-vision standard for all occupations.

“We have identified significant market pain,” Lemelin said. “Everyone who has a colour-vision deficiency needs and deserves to have accurate information about the nature of their colour vision. Unfortunately, even highly trained optometrists and ophthalmologists are unable to objectively discuss colour vision deficiency with their patients because of a lack of a proper diagnosis.”

But solving this market pain takes laboratory work—a lot of costly laboratory work. In the typical life science scenario, a startup such as Genevolve would secure a VC round and yield some control and ownership to the investor for the cash it needs to set up its own lab. Lemelin, however, has opted instead to establish a partnership with a third-party certified facility, rather than surrender control of Genevolve’s destiny.

To the best of his knowledge, this partnership is as rare as it is innovative.

“We have established a rather equitable multi-year agreement with one of the most recognized laboratories in the world,” he said. “We were not interested in a joint venture or a formal partnership, thus we worked out a royalty-based agreement taking lab costs into consideration.”

As usual, the devil is in the details.

“When partnering with others, both parties must benefit and any deals made should be mutually beneficial or the partnership will not work. You also want to avoid anything being too lopsided favouring one party over the other.”

To that end, Lemelin negotiated who would handle what share of the logistical and marketing costs to ensure both parties had a vested interest in a successful outcome. While the lab is responsible for the bulk of the logistics around clinical development and Genevolve’s  market development, both parties share obligations related to the marketing effort.

Covering your assets

But the most important details of the partnership relate to ownership of IP. As we explored in the first post, Genevolve has an exclusive world-wide licence to commercialize the genetic research of husband and wife team Jay and Maureen Neitz and their colleagues at the Eye Institute of the University of Washington in Seattle.

“IP protection is a major issue in partnering with others,” Lemelin said. “In our case, the key patent which encompasses our genetic discoveries is broad and exclusive but it needs to be clear who is bringing in the IP. And who owns any new IP if any is developed. We are constantly working to build the company’s IP portfolio through additional patents, trademarks and copyrights.” However, at this stage, he is reluctant to reveal too much about the strategies Genevolve has instituted to protect its IP.

One of the greatest risks with trying to commercialize a patent related to a body of research that continues to evolve is the fate of the inventor. In Genevolve’s case, that risk is mitigated by the fact that its IP was developed by a duo supported by a research team that has amassed a large amount of clinical data—at this point, the loss of one individual will not derail the entire venture.

Too often, however, this is not the case. For those startups that are dependent on the grey matter of one person, Lemelin offers this advice:

“Get to market FAST!” he said. “Have a contingency plan for every possible event. Do not make major changes and keep it as simple as possible. Learn every detail possible about the IP in case you are forced to pick up unforeseen slack. Do appropriate technology assessment and have multiple potential paths to market … and insurance coverage can be a possible solution to provide further financial protection for the company and investors.”

The business of health

Genevolve is itself pursuing two primary paths to market:

  1. Physicians: Physicians are enrolled through a variety of hooks, including exclusive agreements, patient pipelines, free test kits and the promise of getting a competitive edge by offering improved patient care.
  2. Occupational departments: This comes back to those 100 or more occupations which rely on normal colour vision, requiring employers to accurately test their employees. Genevolve is developing specific tests to meet specific occupational requirements.

“We continue to develop distribution partners, not only through our existing global broker network from our laboratory partnership, but with major players like McKesson (one of the largest pharmaceutical distributors in North America), and with companies that develop colour-vision aids with the goal of adding value to our product,” Lemelin said.

An important aspect is qualifying the test for health insurance reimbursement.

Genevolve’s colour-vision test falls into the category of molecular diagnostics, which can qualify for reimbursement through a complex pricing and fee schedule that uses “stacked codes.” These codes are used to tally up the costs associated with each step that is required to carry out the test, as well as the technology involved. A new test must go through a long and complex process to have new codes created and qualify for long-term insurance reimbursement.

“The process of getting a new code can take years,” Lemelin said. “To begin the process, you must prove a need by demonstrating national acceptance of the test. This process is best described as establishing reasonable use or, more generally, clinical utility. It then would be critical to establish a value-based service that can be economically and medically justified.”

For Genevolve, this means validating the test by securing analytical articles in peer-reviewed publications and demonstrating that its test has become an accepted standard of care through physician testimonials and rates of adoption. However, molecular diagnostics is such a new field, said Lemelin, that there is not yet a standard in place that provides Genevolve with a target adoption rate to aim for.

As we mentioned in our last article, Genevolve is planning to make a big splash at the annual meeting of the American Academy for Pediatric Ophthalmology and Strabismus in March. An impressive showing here could spark the endorsement and early adoption from the broader medical community Genevolve needs to kick start the process of qualifying for insurance reimbursement.

Lemelin has already received positive feedback from practicing clinicians which has him optimistic that Genevolve will secure adequate physician adoption rates. The company also has a practicing optometrist as an investor, which lends further credibility with other physicians.

To VC … or not

Another risk factor facing the business is U.S. President Barrack Obama’s new health care plan, which threatens to tighten the rules governing what qualifies for insurance reimbursement. While Lemelin remains confident that he will be able to meet reasonable usage requirements and show sufficient physician adoption rates to qualify for reimbursement regardless, the Obama plan does create a measure of uncertainty in the market that has many investors wary.

And while Lemelin has always been reluctant to yield control to a venture capitalist, the fact of the matter is, the costs of getting the test to market requires an investment too small to attract the interest of many VCs. In addition, most are not interested in what they deem to be a “service” business. The next step for Genevolve – bringing to market a genetic treatment for colour-vision deficiency – would likely have greater appeal to a VC, but this would still mean surrendering control of the business to secure an investment.

Instead, Lemelin prefers to stick with a more measured approach and seek out the support of private investors. A private placement is another possibility. Once revenue is flowing in from the test, it will provide the capital Genevolve needs to forge ahead with bringing its genetic treatment to market.

“I prefer to commercialize the test, gain the credibility from this major achievement and approach our developing physician network and continue to pitch private investors along the way,” he said.

If all goes according to plan, it will begin with that medical conference in late March. In our next instalment, we will take a look at how the stars are aligning for that launch, the insurance reimbursement system in the U.S., and Genevolve’s contingency plan in case of reimbursement denials.

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Giving a Fair Shake to the Eyes in the Sky ( Francis Moran Series. Part 2)

By Francis Moran and Leo Valiquette

This is the second article in a continuing monthly series chronicling the growth path of Genevolve Vision Diagnostics, a life sciences startup based in Albuquerque, NM that is commercializing cutting edge genetic research to develop new diagnostic tests and gene therapies for colour blindness.

In July 2002, a FedEx Boeing 727 carrying cargo crashed on its approach for a night-time landing in Tallahassee, Fl. A U.S. National Transportation Safety Board investigation identified the first officer’s colour vision deficiency as a factor in the crash and recommended that all existing colour vision testing protocols employed by the U.S. Federal Aviation Administration (FAA) be reviewed. Four years later, this case, and the issues which it raised about colour blindness testing in the commercial aviation industry, was the subject of a panel at an international workshop hosted by Saudi Arabian Airlines.

For Matt Lemelin, CEO of Genevolve Vision Diagnostics, stories such as this validate his company’s mandate, and commercial potential, to redefine how colour blindness is tested, diagnosed and treated. As Genevolve moves closer to its commercial launch, he is eagerly looking at specific industries such as aviation, where there is an opportunity for the company to establish new testing standards that are more fair and equitable. Genevolve’s ultimate goal is to create a global colour vision standard for all occupations.

As we discussed a month ago when we introduced Genevolve, the company’s underlying intellectual property has been recognized by Time Magazine as a top 10 scientific discovery of the year. Lemelin and his team have been working for two years to bring to market the first commercial product for vision professionals – the Eyedox Genetic Test for Color Vision. It’s been a challenging road thanks to meagre funding and a decision mid-course to switch to a different gene-sequencing platform – which delayed the product launch, but promised to reduce costs and improve efficiency and accuracy.

The quest for cash

When we caught up with Lemelin recently, he was busy trying to secure the company’s Series A round – a rather modest sum of US$100,000 – to add to the seed funding the company has already received to date. The fresh capital will be used to refine the business model, fund marketing and to engage in some legal housekeeping to add further protection to Genevolve’s underlying intellectual property.

In recent months, Lemelin has worked his network to reach out to a number of angel investors in the life sciences space. He has racked up significant travel costs and even brought potential investors together for a pitch session. But it has proven difficult to find investors with cash in hand willing to bank on molecular diagnostics. Many investors remain spooked by the current market volatility, while other opportunities lie offshore – securing an investment would incur additional legal costs and complexities.

“The challenge for us has been that there are few proven business models for commercializing molecular diagnostics technology,” Lemelin said. “As exciting as a genetic testing business sounds, many potential investors don’t understand the business, so it scares them off a little.”

But then he found his way to a U.S. finder who was willing to put up the $100,000 in return for a five percent commission and a one percent equity warrant.

“Securing private equity investment remains the best option for the company and from the surface it looks like a splendid investment opportunity,” Lemelin said.

But with any formal investment, the devil is often in the details. To complete the transaction, Lemelin attempted to recycle the future forward agreement template from one of his other investment discussions to save himself some legal costs, but after running it past his attorney, he discovered that even modest investment sums can’t escape the bureaucratic dictates of the U.S. Securities and Exchange Commission. Closing the deal will still incur steep fees and complex regulatory hurdles.

Getting ready to pounce

With or without that cash infusion, is the company on track to meet its yearend product launch deadline?

“I had a conference call with the inventor last week and maybe I will get a Christmas present this year,” Lemelin said. “ Eyedox should be completed by Christmas … which likely means end of January. Nonetheless, real progress is being made.”

But January would still put Genevolve on track to launch at a key trade show event in March – the annual meeting of the American Academy for Pediatric Ophthalmology and Strabismus.

“The future is hard to predict yet I am extremely optimistic – our most promising path of least resistance will be pediatric ophthalmologists,” Lemelin said. “Current tests typically can’t be carried out effectively until a child is five to seven years old. But we can test an infant with amazing accuracy.”

Taking to the skies

But as we said at the outset, Genevolve is also pursuing opportunities in other markets, such as aviation. In military aviation, individuals with colour blindness cannot become pilots. In civilian aviation, individuals with colour blindness can fly, but they face a number of different restrictions which limit their ability to pursue a commercial career, such as a prohibition against flying when they must depend solely on their instrumentation.

The issue, however, are the shortcomings of the tests which are used to diagnose colour vision.

“The FAA is clearly aware that its current methods pass some people who pose a safety hazard and fail others who are likely capable to fly,” Lemelin said. “One particular area to be keen of is air traffic controllers – their screens, along with cockpits, are getting increasingly colour complex, but the testing methods are badly outdated. Even inspectors are unfairly discriminated against because there is an obvious lack of understanding from regulators about testing colour blind employees.”

He is keeping a close eye on changes in the European Union that will see the European Aviation Safety Agency take over aviation regulation from the Joint Aviation Authority. This hand off will also include changes in existing regulations, including those regarding colour vision.

“The issue here is discrimination against pilots,” Lemelin said. “It is not clear how much colour vision a pilot actually needs to safely fly. If we could help mould new European regulations regarding colour vision, it would be a major step towards our goal of establishing a global colour vision standard.”

He believes that all it will take is one national regulator or military adopting Genevolve’s technology to create a domino effect for the company.

Community engagement

To help raise Genevolve’s profile within the aviation industry, Lemelin recently connected with Pedro A. de Ponte, the founder of CVD Pilots, an online community for pilots with colour vision deficiencies.

“Pedro has a number of contacts in the field, including the aviation medical examiners who have successfully overhauled the Australian colour vision rules to the applause of colour blinds everywhere,” Lemelin said.

Genevolve has also attracted the support of Zurich’s Daniel Flück, who runs a prominent blog about colour blindness called Colblindor.

“The recent buzz I am gaining with the aviation community is most exciting, but also in the general colour blind community and tapping into Mr. Flück’s following, this all helps to gaining a foothold,” Lemelin said. “Ultimately we need to become entrenched within the eye doctor community. These guys are a hesitant bunch, but with trade shows and gaining momentum with eye docs, physician adoption will likely grow and I look forward to the day it reaches the tipping point.”

In our next instalment, we’ll explore more in depth the challenges of being a life science startup attempting to secure financing and create a viable business model, the rapidly changing landscape for insurance reimbursement in the U.S., and the risk of your ongoing intellectual property development residing in the grey matter of one individual.

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Genetic Test for Color Blindness

Posted by Daniel Flück on December 2nd, 2011

After almost 100 years since Dr Shinobu Ishihara published his first color blindness test based on pseudoisochromatic plates, we are definitely looking into a new area of color vision testing. Based on the very promising tests of Jay Neitz and his team, where colorblind monkeys started to disinguish certain colors, the company Genevolve is planning to put a genetic color blindness test on the market by the end of 2011.

The Eyedox genetic test for color blindness doesn’t need any pictures or complicated apparatus, but just a few cells from the inner cheek from where your DNA can be extraced from. This makes the test also available for young toddlers and the results can’t be influenced by misunderstanding, light conditions or any other external factors.

Many colorblind people all around the world are looking forward to get such a scientific, precise and fool-prove possibility to test their color blindness. As there are many different tests around these days, and even some online possibilities to test your color vision, you are never really 100% sure if the results tell you the truth. With a genetic test at hand a new reliable option is available. On option which can make you feel more sure to know your real grade of color vision.

Eyedox Color Blindness Diagnosis

If you take an Eyedox color vision deficiency test, not only your cvd type will be diagnosed but also the severity of it. In detail this means:

  • CVD Type: The test is diagnosing anomalous trichromacy including the different subtypes deuteranomaly (green-weak) and protanomaly (red-weak) and alsodichromacy with the subtypes deuteranopia (green-blind) and protanopia (red-blind). This means any type of red-green color blindness is diagnosed in detail.
     
  • Severity: The severity of your color vision deficiency is shown on a scale from 1 to 100 and it is also assigned to one of the degrees very mild, mild, medium, strong or very strong.

Personally I think the strength of the Eyedox test will be the differentiation between a dichromacy and an anomalous trichromacy and a detailed severity analysis of your color blindness. On the other side we have the weakness of the test, that tritanomaly and tritanopia (blue-yellow color blindness) can not be tested with it.

Genetic Treatment of Color Blindness

Many people are not only looking for an accurate cvd test but also a possibility to treat their deficiency and get rid of it. Especially all the colorblind pilot, police officer, and firefighter aspirants, who are rejected because of their visual handicap. Genevolve did not only invenst into a genetic color vision test, but is also looking into the development of a therapy to treat color blindness. Hereafter you can find a possible timeline for this next huge step forward in scientific research of color vision:

  1. In the year 2009 some squirrel monkeys were cured of their color blindness by genetic therapy.
  2. In the same year Genevolve was founded, a “life sciences company which researches, designs and commercializes non-invasive molecular diagnostic assays and treatments for clinical applications for the color vision industry”.
  3. In 2010 a Survey on Gene Therapy for Red-Green Color Blindness was done.
  4. In 2011 Genevolve announces Eyedox, a genetic color blindness test which is based on a non-invasive molecular diagnostics.
  5. Also in 2011 the US Federal Drug Administration (FDA) requires further animal tests which will require maybe another one to two years of testing.
  6. If everything runs smoothly, after that for the first time a handful of selected red-green colorblind people will get a genetic treatment (those are already preselected and nobody can apply for this first test group!)
  7. If they achieve success with the first group, more test subjects will be needed to broaden the treatment and get more detailed test results. If you like to, you can enroll for this second phaseBut be aware, this can take another one to three years until those test will get started.

Anyway. Genevolve, we are all eager to learn more about your next steps and your success stories of treating color blindness and we are looking forward to learn more about your genetic color blindness test as soon as it is available.

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Aviation Personnel Inflicted with Color Blindness Anxious for a Permanent Fix and Frustrated with Unfair Testing Standards – Genevolve has Turnkey Solutions.

By Pedro A. da Ponte

Color blindness is the most common genetic disorder in humans affecting hundreds of millions around the world. The condition is predominantly present in males and congenital in nature thus it remains unchanged throughout a person’s life. Color blindness can have disastrous effects on the aspirations of pilots and other aviation personnel. One extremely controversial aspect affecting the entire aviation industry, from ATC’s to aircraft inspectors and especially pilots, is current color vision testing methods and the accuracy of results.

There is no globally accepted testing method and this is of particular importance to the European Union as EASA takes over the JAA. One country may test color vision using the oft used and badly outdated Ishihara, invented by Japanese ophthalmologist, Dr. Shinobu Ishiáhaára in 1917. It is a widely accepted fact that the test has inherent flaws, passing some that may have trouble distinguishing colors and denying many that are surely capable of commanding a cockpit. Another country on the other side of the globe may use the Holmes-Wright Lantern or a Farnsworth color arrangement test with each test possessing its own set of validation concerns. If a pilot is to fail any one of these tests, they are normally red-flagged and discriminated against, in the form of stiff restrictions, likely for the rest of their careers’ or worse yet barred from flying altogether. This leads aspiring pilots to pass a test in a country with loose standards and fly into a tightly restrictive country thumbing their nose. If an individual is to slip thru the system, a life of fear of being found out is a constant threat. 

There is a solution to these unfair testing standards on the horizon which doesn’t include moving to Timbuktu. Genevolve Vision Diagnostics has developed a genetic test for color vision. “It is the first totally objective color vision test that can consistently separate color blind individuals from those with normal color vision and accurately classify color vision deficiencies. As such, it offers a solution to the problem of setting uniform standards in the workplace” said Genevolve president Matt Lemelin. These days, if a medical examiner identifies the slightest color vision defect, a complex and costly battery of tests is ordered or worse yet, the individual is black listed. With all of these tests, each having their own inconsistencies and improprieties, many workplace advocates are clamoring for a globally accepted fair testing standard. The genetic test is a major step towards this goal as it is expected to increase pilot admissions by up to 40% and eliminate false positives by 100%. The test is planned to be available to clinicians by the end of the year. We encourage pilots and other aviation personnel to voice their opinions on the CVDpilots.com forum and join forces to overcome the political landscape and adopt fair testing standards.

The genetic test, and much of what is known about color vision itself, represents decades of research by the husband and wife team of Jay and Maureen Neitz, PhD., who are both professors of Ophthalmology, and Biological Structure at the University of Washington. "In addition to the genetic test, we have discovered a method to cure color blindness and our goal is to commercialize it by 2013” says Neitz. The procedure using a gene therapy technique, shown effective in monkeys has been featured in the publications, Nature and National Geographic and named by Time magazine as one of the top 10 scientific discoveries of the year. The monkeys have been closely followed after only one treatment applied several years ago. The results are extremely encouraging since the monkey’s color vision is as robust as when the procedure was first applied. “I can see a future where an individual is tested with our genetic test early on in life and the gene therapy procedure is applied as a standard of care, but to reach this goal, we must overcome a few obstacles” said Lemelin. One hurdle is funding; Genevolve is offering an investment opportunity to qualified investors and the company is particularly keen to involve color blind individuals to tap into personal passions of finding a cure. For the most part, regulatory requirements have been met and the initial feedback from the pre-clinical trial is very positive. Further animal testing is being performed as the company is gearing up for actual applications in human beings. To confidentially register as a test subject and to receive regular updates, go to http://www.genevolve.com/test-subject-enrollment.html.

The Forum post is edited by Pedro Nov 29

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Meet Genevolve Vision Diagnostics ( Francis Moran Series. Part 1)

By Francis Moran and Leo Valiquette

This is the first article in a continuing monthly series that will chronicle the growth path of Genevolve Vision Diagnostics, a life sciences startup based in Albuquerque, NM that is commercializing cutting edge genetic research to develop new diagnostic tests and gene therapies for colour blindness.

 

 

When a startup’s underlying intellectual property has already been hailed by Time Magazine as one of the year’s top 10 scientific discoveries, it may foster the perception that the road to commercial success is already assured. But president and CEO Matt Lemelin and the team at Genevolve Vision Diagnostics have learned that a great discovery is only the beginning of a long and challenging journey.

“We are creating a new market with an advanced technology that many said was not possible,” Lemelin said. “We’ve been labeled as pioneers, a term that concerns me ever since I heard a seasoned veteran state ‘pioneers get slaughtered, settlers prosper.’”

Genevolve Vision was founded in 2009 to commercialize non-invasive molecular diagnostic assays and treatments for clinical applications in the colour vision industry. It operates in two segments: licensing its IP to third parties and establishing partnerships to develop new products; internal R&D to create and commercialize novel diagnostic tools and treatments.

After two years of commercialization activity, Genevolve is a few months away from its product launch. In this first post, we will explore how the startup has reached this point and what has been learned along the way.

The tale of two colour-blind monkeys

In 2009, husband and wife research team Jay and Maureen Neitz and their colleagues at the Eye Institute of the University of Washington in Seattle used gene therapy to treat colour blindness in two adult monkeys. They had injected the genes responsible for producing colour-detecting proteins into the monkey’s eyes, allowing them to see red and green for the first time.

The breakthrough earned the team a writeup in Nature and other leading scientific publications, as well as that recognition as a discovery of the year from Time Magazine.

Not only had this successful experiment illustrated that gene therapy could be used to treat colour blindness, it laid the ground work for a genetic test that could diagnose colour blindness in a far more accurate and thorough manner than existing tests. The most common colour blindness test, the Ishihara test, is almost 100 years old. It presents patients with a picture filled with a field of dots in which is hidden a number or letter that is formed by a pattern of dots of a different colour. The problem with this test is that it can be fooled and it can’t be used to determine the severity of the patient’s condition.

Lemelin learned of the Neitzes’ work from his contacts in the industry. At the time, he was already a serial entrepreneur and was working as marketing director for a company that supplied conventional colour vision testing products to doctors and clinicians.

“My time as a marketing director allowed me extensive interactions with practicing clinicians,” he said. “These interactions gave me some first-hand insight into what the problems are facing the industry … the market pain was clear to me. We are competing against, albeit cheaper, but extremely outdated products which can misdiagnose or simply not diagnose patients.”

A few discreet inquiries led to some “long and shrewd negotiations” with the patent holders that resulted in an exclusive world-wide license to commercialize the Neitzes’ inventions through a startup venture – Genevolve. Today, the Nietzes continue their research work at the University of Washington, while Genevolve also operates a clinical laboratory in New Mexico.

“Our genetic test is highly accurate, provides substantially more information (compared to conventional tests), cannot be cheated and is reimbursable by insurance companies,” Lemelin said. “Most importantly, our product saves doctors time, and time is everything to these guys.”

When an angel investor tells you to bootstrap …

But these competitive differentiators have not easily translated into investment capital.

“The capital needed to commercialize our technology was badly underestimated,” Lemelin said.

He made the decision at the outset to not involve venture capitalists and bootstrap the startup with personal assets and friends and family money. When he did approach angel investors, the response was “you need to bootstrap it and form more strategic partnerships.”

Lemelin took that advice to heart and secured partnerships with a few major players in the industry, took a sales job to keep a roof over his family’s head rather than drain capital out of the business and tapped into seasoned mentors and coaches who provided him with invaluable advice, including a lawyer who has provided legal services for a nominal fee.

“I find that there is an abundance of assistance out there if you are willing to find it and most importantly ask for help,” he said. “I hope to one day repay, in a big way, the people who have sacrificed, looked beyond bottom lines and have guided me along. This mindset will never be forgotten and it will be implemented in my company’s culture.”

The technology has continued to move closer to market thanks to the support of a few private investors, including one who is a practicing optometrist, which has added credibility to the venture.

Levering existing relationships with eye-care practitioners has also been a key piece of the puzzle.

“I have a core of eye doctors that I have built relationships with over the years,” Lemelin said. “This handful of doctors returns critical information to me about the product and if we are hitting the mark or not. We can then go back and tweak things and try again.”

The team has also taken advantage of the wealth of free market data available online, industry blogs and social media polls to get the pulse of the market.

“We are a marketing-based company,” Lemelin said. “We have to be. Without a strong marketing push, failure is likely. The advent of social networking has changed everything, especially in the biotech arena. It’s a new kind of openness that traditional industry insiders are not accustomed to.

“To take a technology to market, you can’t just throw up a website and hope for the best; the arsenal must be filled with FacebookTwitter, LinkedIn, blogging and other tools for customer engagement. When I first started I was holding on to every tidbit of data and not going public with anything, now I am an open book. I am working towards becoming the authority in my space.”

Where is Genevolve today?

After two years of effort, Genevolve is aiming to make its first product, the Eyedox Genetic Test for Color Vision, available for clinical use by the end of 2011. Considering that insurance reimbursement can take two to four months to process, the startup is aiming for profitability within eight months of its product launch.

“Our revenue targets are quantified best by enrolling vision clinicians into our system,” Lemelin said. “Our goal is to enroll 50 eye doctors per month through our various marketing efforts. We have other targets as well – distribution, opening international markets, regulatory goals, striking strategic partnerships.”

The startup is in fact running behind its original launch target. This is due to a decision mid-course to change from a widely used gene-sequencing platform to one that was more robust to reduce costs, and improve efficiency and accuracy.

“On one hand we improved the results of the test, thus improving the appeal to doctors but substantially delaying revenue generation,” Lemelin said. “On the other, we afforded our marketing team more time to clarify strategies and better define our path.”

But regardless of the science involved, the heart of Genevolve, as it is with any startup, is the collective vision and fortitude of the team.

“We know we have the sure thing,” Lemelin said. “Just ask any entrepreneur. Living the dream isn’t just dreaming, it’s tossing and turning.”

In the coming months, we will explore in more detail aspects of Genevolve’s path to market and track how the stars are aligning for its product launch.

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Genevolve Develops Key Genetic Test for Color Blindness

September 28, 2011 – ALBUQUERQUE, New Mexico

Genevolve Vision Diagnostics Inc. has developed a non-invasive molecular diagnostic for all major forms of congenital color blindness.  It is the first totally objective color vision test that can consistently separate colorblind individuals from those with normal color vision and accurately classify color vision deficiencies.  As such, it offers a solution to the problem of setting uniform standards in the workplace.  And, for the first time accurate testing of children as young as 6 months of age will be possible.  “The new test is a game-changer as it is a revolutionary improvement in color vision testing which had not changed in the last 60 plus years,” said Genevolve president Matt Lemelin.  The genetic test, and much of what is known about color vision itself, represents decades of research by the husband and wife team of Jay and Maureen Neitz, PhD., who are both professors of Ophthalmology, and Biological Structure at the University of Washington.

They worked out the molecular genetic basis for why there are large individual differences in the severity of colorblindness among people with the defect.  It is one of the first examples of a defect of the nervous system where examination of a person’s DNA can predict not only the occurrence but also the severity of a defect.  The team of researchers has also developed a treatment for the disorder using a gene therapy procedure proven effective in monkeys and featured in the publications, Nature and National Geographic.  The discovery was named by Time magazine as one of the top 10 scientific discoveries of the year.

The test, marketed under the Eyedox™ brand, involves using a non-invasive buccal epithelial cell collector to pick up skin cells sloughed daily from the lining of the mouth.  The DNA goes to a CLIA certified laboratory where the color genes, which are expressed in the eye but are present in all cells, are specifically analyzed to give both a precise identification and an accurate classification of any inherited color vision deficiency along with a treatment plan and family history which provides information about the inheritance of the disorder.
“This is a major breakthrough because scientists strive to understand the genetic basis of human disease, it is often more important to forecast the severity of the impairment than to merely reveal the presence of a genetic defect,” said Dr. Jay Neitz.

About color vision
Congenital or inherited colorblindness affects the photoreceptors that absorb light in the red-green visual spectrum.  Color vision deficiency is the most common genetic disorder in humans.  The disorder is most often inherited as the result of mutations on the X chromosome and therefore is predominantly present in the male population.  It has been estimated that 1 out of 8 males and 1 out of 200 females possess some form of inherited color vision deficiency.  Studies indicate there are 13.5 million color vision deficients in the United States and more than 200 million worldwide.  Studies show that current testing methods are unreliable, classifying some people with normal color vision as being colorblind, especially young children, and some people, even with severe color vision defects, as being normal.  There have been aviation accidents and railway disasters attributed to color vision deficiency increasing the need for more objective color vision testing methods and accurate standards.  

About Genevolve Vision Diagnostics
Genevolve Vision Diagnostics, Inc. is a life sciences company which researches, designs and commercializes non-invasive molecular diagnostic assays and treatments for clinical applications for the color vision industry. The company operates in two segments; external agreements and internally held intellectual property. The external agreements section offers partnering options for technology companies and innovators within the color vision industry and provides a commercialization vehicle including product development, distribution options, marketing services and other business services on a contractual basis. The internally held IP segment researches, licenses, develops and commercializes novel molecular diagnostics and treatments for color vision deficiencies. The company was founded in 2009 and is based in Albuquerque, New Mexico.

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Medical College of Wisconsin Awards Genevolve Vision Diagnostics Patent for Human Color Genes.

Nov. 15, 2010 - ALBUQUERQUE, New Mexico

Genevolve Vision Diagnostics Inc. has acquired exclusive rights to the, patent for the human genes responsible for common, hereditary, red-green colorblindness. Genevolve acquired a broad patent license covering the human genes for color vision from the Medical College of Wisconsin in Milwaukee. The patent also covers a revolutionary test for color blindness based on a simple analysis of the actual genes that cause the problem. The new test is the first major improvement in color vision testing in the last half of a century.

It is also the first totally objective color vision test that can consistently classify color vision deficiencies. As such, it offers a solution to the problem of setting uniform standards in the workplace. And, for the first time, accurate testing of children as young as 6 months of age will be possible.

The genetic test, and much of what is known about the genetics of color vision itself, represent years of research by the husband and wife team of Jay Neitz, Ph.D., professor of cell biology, neurobiology and anatomy, and ophthalmology; and Maureen E. Neitz, Ph.D., professor of ophthalmology, and cell biology, neurobiology and anatomy at the University of Washington.
They worked out the molecular genetic basis for why there are large individual differences in the severity of color blindness among people with the defect. It is one of the first examples of a defect of the nervous system where examination of a person's DNA can predict not only the occurrence but also the severity of a defect. The team of researchers has also developed a treatment for the disorder using a novel gene therapy procedure proven effective in monkeys and featured in the publication, Nature.

The test involves using a noninvasive buccal epithelial cell collector to pick up skin cells sloughed daily from the lining of the mouth. The sample goes to a CLIA certified laboratory where the color genes, which are expressed in the eye but are present in all cells, are specifically analyzed to give both a precise identification and an accurate classification of any color vision deficiency along with a treatment plan and family history.

"This is a major breakthrough because as scientists strive to understand the genetic basis of human disease, it is often more important to forecast the severity of the impairment than to merely reveal the presence of a genetic defect," said Dr. Jay Neitz.

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DNA lab at NMSU partners with company to fight colorblindness; seminar planned

WRITER: Justin Bannister, (575) 646-5981, jbannist@nmsu.eduNMSU

CONTACT: 

Matt Lemelin, (505) 798-2665, matt@genevolve.com

Stefan Long, (866) 833-6895, s.long@ctldna.com

The Clinical Testing Laboratories at New Mexico State University will soon begin genetic screenings for colorblindness. The testing is the result of a partnership with Genevolve Vision Diagnostics Inc., an Albuquerque-based company that has created the first-ever genetic test for color vision deficiency. The company is also working to eventually cure colorblindness through gene therapy.

CTL and Genevolve will discuss their partnership and the process for testing and potentially curing colorblindness during a seminar scheduled from 4-6 p.m. Friday, Feb. 26, at the NMSU Golf Course Clubhouse. Professors, eye doctors and others interested in the procedure are encouraged to attend.

"Our goal is to establish a new world standard for color vision testing and to increase public safety while providing a diagnosis that doctors may discuss with their patients," said Matt Lemelin, founder and CEO of Genevolve. "With this process, we can now diagnose the type of colorblindness and the extent of deficiency with amazing accuracy and precision."

Lemelin said colorblindness affects one in seven males and one in 200 females, which translates to approximately 13 million people in the U.S. and 200 million people in the world. It can also seriously impact public safety. More than 100 occupations have standards for colorblindness, including pilots, firefighters, police and the military.

Lemelin said drawbacks to the 10 or so current colorblind tests include having to wait until a child is 5 years old before testing. Waiting that long could potentially affect a child's development, especially if they have special needs. Lemelin said it is also easy for adults to memorize the answers or find other ways to fool colorblind tests, which can have potentially dangerous results.

"The National Travel Safety Bureau has linked a number of accidents to the loss of color vision. The Federal Aviation Administration states it is likely that, in some circumstances, color vision deficiencies may result in unsafe conditions," he said.

The genetic test for colorblindness was created by Jay Neitz, a researcher from the University of Washington. Through his research in gene replacement therapy, Neitz has also cured red-green colorblindness in nine adult primates.

Genevolve will contract with CTL to process the DNA samples for the colorblindness test. CTL may also be involved in future work for the company once the clinical trials for the gene therapy cure have progressed further.

"If this does half of what we expect, this partnership would create 20 to 40 additional, good-paying jobs at the laboratory," said Stefan Long, CTL's general manager.

CTL is part of a group of DNA and forensic testing businesses spun off from NMSU in 2005. In addition to CTL, the group also consists of The Forensics Testing Laboratory, The Genetics Testing Laboratories and Fire and Crime Scene Advanced Continuing Education. Each operation is housed at NMSU's Arrowhead Genesis Center.

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