Should You Get Tested For The Breast Cancer Gene?

It’s been a while since we’ve taken a look at the various “at home DNA tests” available from companies like 23andMe, Ancestry.com, and Family Tree DNA. What each of these DNA tests has in common is that they all offer ancestry testing so that you can see if you are related to anyone else that took the same test. They don’t dabble in anything related to genetic health, though 23andMe did try before. When they did decide to start offering hereditary cancer tests, the FDA slapped their hand for not having received FDA approval before offering such tests. Since then, 23andMe has received FDA approval for some health related tests but, none related to hereditary cancer testing. That space is now occupied by a number of companies including one called Color Genomics which has taken in a fairly large amount of funding to sell at-home DNA tests which look for 30 different types of cancer genes.

Color Genomics Logo>

Founded in 2013, Color Genomics has taken in

$150.5 million to “democratize access to high-quality genetic information”. At the present moment, that means selling tests that can detect hereditary cancer and hereditary high cholesterol. (According to Color, about 10-15% of most cancers are due to inherited genetic mutations.) Investors in the startup include some prominent names the CTO of Cisco, a co-founder of Yahoo, a co-founder of PayPal, and Khosla Ventures.

The company’s flagship test offering is a 30-gene cancer test called “Color” which can be taken at home. In order to purchase the $249 test, it first needs to be requested by a doctor. Of course if you don’t want to bother your doctor, they’ll provide a doctor’s approval for you. Upon providing payment for the test, the patient then can talk with Color Genomics about family history of cancer before the test, get the actual test results, and then receive counseling along with the results should they prove to be positive. Color has partnerships with a number of large corporations to offer this as an employee service, and they also offer free genetic testing to underserved individuals (one could argue that both sides are getting something of value here). Below you can see some examples of the genes they test for, and the types of cancer they predict (not all 30 genetic markers are shown below):

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While you would expect that most people would test negative for these genetic markers, the million dollar question is what are you supposed to do if you test positive to a particular marker and what does that mean? In a nutshell, a positive test means that you have a greater likelihood of coming down with that particular type of cancer based on genetic susceptibility. At that point, there are certain preventative measures that can be taken, which is why the FDA has expressed some concern. Do we really want women who test positive for the BRCA1 gene going out and pulling an Angelina Jolie? While such extreme measures may not be warranted, testing early and often would be an appropriate step to take. The 5-year survival rate for breast cancer rises from 25% to 98% when detected early as opposed to being discovered in an advanced stage.

The Color Test analyzes the most relevant genes for mutations that could increase a patient’s risk for breast, colorectal, melanoma, ovarian, pancreatic, prostate, stomach, and uterine cancers. The reports themselves are of a high quality as you can see in the below samples:

They also state that if you receive a positive result, your first-degree relatives can get tested for just $50 each. Until we have smart toilets that test our urine streams for cancer every morning, it probably makes sense to take proactive measures if you have a family history of particular types of cancer. Still, for most of these cancers there aren’t really any concrete measures we can take aside from getting body parts removed and getting tested more frequently. Here are a few things Color Genomics says about the results:

  • Please keep in mind that there is no right or wrong option when deciding on a plan to reduce your risk of developing cancer. It is a very personal choice.
  • Your actual risk may be different based on other genetic and non-genetic factors.

Wouldn’t it be fun to get their marketing person on the phone with their legal person and hear them both “work together” to try and explain these statements? What this seems to say is that we should take the risk numbers with a grain of salt and that there are no proven preventative measures that we can take aside from getting tested early and often. Since Americans probably worry more than any other culture on the planet, these tests should be selling like hotcakes. Of course Color Genomics hardly has a monopoly on these types of tests which is a good segue into the topic of competition.

The story starts with a company called Myriad Genetics (NASDAQ:MYGN) which began selling a hereditary cancer test way back in 1996. Up until 2013, Myriad actually had a patent on the BRCA1 gene (that’s the gene which predicts breast cancer risk). When the Supreme Court invalidated that patent, it created an opportunity for companies like Color Genomics (coincidentally founded in 2013) to enter this space. Just to give you an idea of how much money there is to be made here, Myriad Genetics brought in $127 million in the last 3 months of 2017 selling their myRisk hereditary cancer test, a number which is about 12% less than the same period in 2016. Like Color Genomics, they also test for a variety of cancers but use 28 genetic markers instead of 30:

That large revenue number can be partially explained by the fact that Myriad Genetics sells their test at around a $4,000 price point. That’s 16X the price of the Color Genomics test which helps explain why Color Genomics talks about “democratizing access to high-quality genetic information”. In an interview with CB Insights, Color Genomics’ CEO Othman Laraki talks about how that low price point has been made possible by a great deal of automation along with economies of scale, as Color Genomics now has one of the largest testing labs in the United States. For example, while most genetic counselors might spend an average of four hours per patient, Color Genomics has brought that number down to 37 minutes.

With their latest funding round closing in August of 2017 for $80 million, we can only guess that things are going really well for Color Genomics. According to an article by CNBC around the time of that last funding round, “other areas that Color’s team is exploring include preventative tests for neurological health, behavioral health, as well as family and reproductive medicine company is said to be exploring include preventative tests for neurological health, behavioral health, as well as family and reproductive medicine“. Once they have someone who has taken any single test, it’s then easy enough to up-sell additional tests. For example, they offer their cholesterol test at a discounted price for those people who have already taken the hereditary cancer test.

In a future article, we’ll put together a list of all the companies that are offering hereditary cancer tests in order to see who all the players are. In the meantime, you can pick up a Color Genomics test >right now on Amazon for $249

. If you just want to analyze your BRCA1 and BRCA2 genes (associated with an increased risk for hereditary breast and ovarian cancer), that’s on sale now >for just $99

. Just make sure you ask your doctor first.

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Source : https://www.nanalyze.com/2018/02/hereditary-cancer-tests-color-genomics/

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