Kalorama information suggests that the FDA approval of a rare gene test from Mountain View, Calif.-based personal genetics company 23andMe will open the way for more genetic tests sold to consumers or prescribed by doctors that use next-generation sequencing technology. A Feb. 19th approval letter from the FDA has cleared a test for a gene that can cause a rare disorder called Bloom Syndrome, which causes short stature and a heightened risk of cancer. Most importantly the letter hints at a reduced review process for similar tests. In the healthcare market research firm's report, Next Generation Sequencing 2015, 23andme and several other companies and sequencing-based tests like theirs are discussed.
Kalorama notes that the new policy, coming just 15 months after 23andMe received an FDA warning letter, represents the agency's attempt to adjust to the demand for applications for sequencing technology while still maintaining a regulatory role for advanced diagnostic tests.
"The reversal of policy was probably inevitable, given that the agency's actions if continued would diverge from the trend towards personalized medicine, patient-centered medicine, and the sharing of important medical information with patients," said Bruce Carlson, Publisher of Kalorama Information. "A balance has been struck here."
Kalorama notes that President Obama's personalized medicine program as part of his 2015 budget proposal, and the recent approval of MiSeqDx hinted that the US government was seeking a friendlier approach towards any test that might help consumers identify risks and aid the healthcare system in diagnosis and prevention. The approval of the particular test (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM435003) is aided by on the certainty involving this gene in a prenatal test. It's a rare disorder but more common where both parents are of Ashkenazi Jewish descent. If both parents have the a version of the gene, their child will have the disorder.
"Had this been the only test affected, it still would have been a positive news story for the next generation sequencing and IVD industries, but the FDA's letter also contained this note, hinting at a broader change in regulation of genetic tests," Carlson said.
The FDA approval letter noted that: "Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market."
A testmaker now has to notify the FDA and be sure that its diagnostic met certain requirements. 23andMe had to demonstrate that the test was accurate, could be validated across laboratories, and that the report of test results were comprehensible to individuals not previously familiar with the DNA test kit.