Color Genomics Launches Breast Cancer Risk Panel That Circumvents FDA Approval Requirements

image

A new Silicon Valley startup called Color Genomics has launched a $259 genetic testing service designed to inform consumers of their potential risk for breast or ovarian cancer. The company was founded by Elad Gil and Othman Laraki, a pair of early Twitter employees with limited practical healthcare background but an abundance of experience engaging consumers. The team sold Mixer Labs to Twitter in 2009, a startup that built an API that helps developers incorporate location-aware features in apps. After the acquisition, the pair stayed with Twitter and went on to oversee geo-location features, and then search and eventually overall growth for the company. Before moving into consumer design, Gil graduated from MIT with a PhD in genetics, where he studied both cancer and genetic testing.

Now Gil and Laraki are leaving consumer development and refocusing their efforts on genetics. Their startup, Color Genomics, is backed by well-regarded industry investors, including Khosla Ventures, and Laurene Powell Jobs, Steve Jobs’ widow. The story of a well-connected Silicon Valley personality diving into direct-to-consumer genetics testing is of course a familiar one. Anne Wojcicki, wife of Google co-founder Sergey Brin, launched 23andMe to offer a nearly identical service, only to be shut down by the FDA for presenting consumers with risk profiles that the FDA said had not been exhaustively validated. 23andMe’s regulatory setbacks are ongoing, and the company is actively pursuing new monetization strategies that minimize its reliance on consumer-generated revenue.

Color Genomics is attempting to circumvent the more stringent direct-to-consumer FDA requirements by insisting that only doctors order their genetics tests, putting them in the same class as other private laboratory providers like Quest Diagnostics. What differentiates Color Genomics from Quest Diagnostics is that if a consumer wants a genetic screening from Color Genomics, the startup has doctors on staff that can order the test on behalf of consumers, providing a loophole that will essentially allow them to market their genetic testing direct to consumers via an employed physician that will order the test and then explain the results.

The screening test itself is small in scope and is based on reputable science. Color Genomics is looking for  BRCA1 or BRCA2 mutations which have been directly linked to increased risks of developing breast cancer and ovarian cancer. These mutations only occur in one to two percent of the population, but correlate with an 80-percent lifetime risk of developing breast cancer and a 50-percent chance of developing ovarian cancer. The new tests are now available because in 2013 a Supreme Court decision nullified a patent on BRAC1 and BRAC2 held by Myriad Genetics, which was charging upwards of $4,000 for the same genetic screening tests. In the case, the Supreme Court ruled 9 – 0 that research firms could not patent human genes. As a result, companies like Color Genomics are entering the market, and are establishing a radically new price point for the screening tests in a post-monopoly market.


Enjoy HIStalk Connect? Sign up for update alerts, or follow us at @HIStalkConnect.

↑ Back to top

Founding Sponsors

Platinum Sponsors