At-Home Genetic Testing Goes Beyond Just DNA
April 18, 2018
TechTalk looks at 23andMe’s DNA test-taking kit and its recent approval by the FDA to scan for certain breast cancer genes. We examine the possibilities and limitations, where the market is headed, and what it means for the biotech industry and its business advisors.
DP: Good. So last time we spoke we talked about the Apple Watch accessory that can act as an EKG. So now the 23andMe, that mail-in DNA test-taking-kit company (there’s a few of them out there) but the kit can actually tell customers about three mutations in the breast cancer genes BRCA1 and BRCA2. Now these are a couple of consumer-based products that the FDA has really had a hand in repositioning.
DK: Correct. The trend has been increased access to health care information. 23andMe received FDA authorization on carrier test for Bloom Syndrome in 2015 and risk report for several conditions such as Parkinson’s and Alzheimer’s in 2017. Industry people have called it the continued march of the democratization of health care.
DP:What’s the down side here?
DK: So 23andMe only tests for three mutations in BRCA1 and one in BRCA2. These mutations are among the most common and best studied but they still account for only a fraction of hereditary breast cancers in the U. S. There are more 1,000 known BRCA mutations, some of which are linked to increased cancer risk, some of which aren’t, others whose risk is unknown. So the test doesn’t cast a very wide net, and it’s certainly not a replacement for regular visits to your physician.
DP:What are we talking about here in dollars and cents?
DK: A variety of companies offer kits that cost anywhere from $99 to $199 each. The global consumer genetic testing market was $70 million in 2015 and is expected to be $340 million by 2022.
DP:That’s almost a fivefold increase. So how might something like this, what we talked about as far as the increased access to health care information, how can this impact the life science and biotech sector as well as impact people like you who provide business consulting services?
DK: Anytime a company can move through FDA approval, it’s good for the industry. It challenges other companies; it shows the willingness of the FDA to accept newer methods of testing. So we should see continued investing and funding in the industry, and with that comes the need for qualified business partners to be there every step of the way.
DP:Great. Dave, thanks for your expertise here.
DK: Thanks Dave.
DP:And thank you for listening to another episode of TechTalk, as part of the EisnerAmper podcast series. Visit EisnerAmper.com for more information on this, and a host of other topics. And join us for our next EisnerAmper podcast when we get down to business.