BRCA screening. Opioids vs. non-opioids. Medicaid.
Once at odds, it seems that now 23andMe and the FDA are best buds.
This week, 23andMe got approval from the FDA for a direct-to-consumer screening test for mutations of the BRCA gene, which is linked to significant increases in the chances of developing breast cancer. The test looks specifically at 3 variants of the BRCA mutations prevalent in specific groups (e.g. Ashkenazi Jews). No prescription or physician is needed for consumers to access this test.
It’s pretty amazing how far 23andMe has come since it received a cease and desist letter from the FDA in 2013. It’s getting approvals for things the FDA explicitly called out back then!
“Some of the uses for which [the Personal Genome Service] is intended are particularly concerning, such as assessments for BRCA-related genetic risk…For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.”
23andMe has recovered from the FDA’s worries about false positives and unnecessary screenings to becoming a pioneer in the genomics market and the direct-to-consumer healthcare market.
The FDA meanwhile has pushed to open more direct-to-consumer channels, especially in the wearables and diagnostics market, through regulations like the Pre-Cert Program.
However, the 23andMe screening test is interesting because it’s much further upstream in disease detection. In other words, it only tells you the risk of potentially developing a disease down the line, i.e. it’s not a diagnostic or monitoring tool.
The genomics bottleneck
23andMe is putting a lot of data into patient hands. I’m in the camp that the more data patients are armed with, the better. But revealing health risks and predispositions could tax our already struggling health infrastructure.
The pace of direct-to-consumer testing is only going to accelerate as more money goes into the space. Competitor Helix just raised $200M to increase its marketing. With the FDA approving 23andMe’s test, we can expect the floodgates to open for more competitors offering direct-to-consumer cancer screening.
How can we close the gap between giving data to patients and also giving them access to counseling to make sure they take the right next steps? How are we going to scale care and monitoring in tandem with the number of people learning about their possible future health risks? Maybe the rapid rise of genetic screening is the telemedicine catalyst we’ve been waiting for.
For expert intelligence clients, we mapped out 58 device makers that are shaping disease management in different specialties.