MAR 19, 2015 09:11 AM PDT

23andMe FDA Approval Clears Way for More Sequencing-Based Tests

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.

Source: Kalorama
About the Author
  • Ilene Schneider is the owner of Schneider the Writer, a firm that provides communications for health care, high technology and service enterprises. Her specialties include public relations, media relations, advertising, journalistic writing, editing, grant writing and corporate creativity consulting services. Prior to starting her own business in 1985, Ilene was editor of the Cleveland edition of TV Guide, associate editor of School Product News (Penton Publishing) and senior public relations representative at Beckman Instruments, Inc. She was profiled in a book, How to Open and Operate a Home-Based Writing Business and listed in Who's Who of American Women, Who's Who in Advertising and Who's Who in Media and Communications. She was the recipient of the Women in Communications, Inc. Clarion Award in advertising. A graduate of the University of Pennsylvania, Ilene and her family have lived in Irvine, California, since 1978.
You May Also Like
AUG 30, 2018
Cell & Molecular Biology
AUG 30, 2018
Simultaneously Assaying Gene Expression and Chromatin Availability
Traditional tools often focus on one aspect of a cell, but a new technique can assay the expression of 1000s of genes in 1000s of cells at once....
SEP 11, 2018
Immunology
SEP 11, 2018
Oops! I Broke My DNA
Innate Immune System, DNA Damage and Repair...
OCT 18, 2018
Cell & Molecular Biology
OCT 18, 2018
An Unexpected Role for Astrocytes
The brain starts out as a dynamic organ that is capable of many changes. That flexibility allows us to learn, adapt and grow....
OCT 21, 2018
Genetics & Genomics
OCT 21, 2018
The Genetic Cause of Severe Childhood Epilepsy is Revealed
This work has opened up new therapeutic avenues that the scientists will be exploring....
NOV 10, 2018
Genetics & Genomics
NOV 10, 2018
Scientists Engineer a Better Way to Direct Evolution
Directed evolution is a Nobel-prize winning technique that has now been simplified and accelerated....
NOV 16, 2018
Genetics & Genomics
NOV 16, 2018
Using Light to Control Organ Development
Optogenetics combined genetic engineering with optics to create a way to control cellular behaviors with light....
Loading Comments...