Fascinating “DIY” DNA Sequencing Battles: Upstart Color Genomics Vs. Upstart 23andMe Edition

You will recall that I have been paying rather close attention to the winding path the $99 DNA spit test company called 23andMe is now traversing at FDA. I was an early adopter in mid 2013 — prior to the FDA clamp-down on health related DNA data, there.

Fast forward to this week. Color Genomics has launched a more expensive spit test — at $250 per kit — and is focusing on heritable breast cancer risks (and thus targeting women). [Color is backed in part by Steven Jobs’ widow — ironic that 23andMe is led by the separated wife of a Google founder.] In any event, even as 23andMe seeks FDA approval to once again provide that very same data to people who’ve previously bought its spit kits, Color has launched using on-staff doctors to “administer“, and then refer test results to the “patients” who’ve bought their kits.

The claim here is that the staff doctors are using a medical test, inside their own offices, and are thus exempt from the more stringent FDA approvals — for a new so-called 410K diagnostic device (under FDA’s jurisdiction). I truly will enjoy watching this, but it will likely be “game over” for Color, should 23andMe ultimately get an FDA green light — on their DTC (direct to consumers) health data related to these same breast cancer risks. Here is a bit of the blogosphere, on Color’s launch — for background mostly:

. . . .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 [path is] ongoing, and the company is actively pursuing new monetization strategies that minimize its reliance on consumer-generated revenue. [Ed. Note: Actually 23andMe is relatively close to validating their tests — and clearing FDA, to provide the same service Color claims to provide, at 40 per cent of the price of Color — with a wider array of test results.]

. . .Color Genomics is attempting to circumvent the. . . 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. . . .

We will stay tuned — and I do generally applaud the idea of democratizing our own genomic data — but I think the pitch Color is using is a little over the top. Color argues that every woman over 35 in the US ought to pay out of pocket to get their spit test. In families with a history of breast cancer, I might agree. But clearly Color simply wants to cut a wider market-swath — with that breathy rhetoric. Anyone care to take the other side of the argument? Anyone? . . . Bueller. . . Bueller. . .

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