NEW YORK (GenomeWeb News) – The US Food and Drug Administration sent out a blast of letters this week warning 14 companies that they are marketing unapproved genetic tests that require 510(k) approval or pre-market approval from FDA as medical devices.
The warnings come during a week when FDA held a public meeting to discuss possible regulations of lab-developed tests, and when the Committee on Energy and Commerce in the US House of Representatives met to hear testimony about genetic testing from the Government Accountability Office, which was tasked last year with producing a report on potential consumer fraud in the genetic testing market. The GAO testimony, which was given today, was based on its review of four companies, including Pathway Genomics, Navigenics, 23andME, and Decode Genetics.
The 14 FDA letters are similar to a set the agency sent out in June to 23andMe, Decode Genetics, Navigenics, and Illumina.
The letters sent this week ask the firms to explain their belief that they do not require FDA clearance for their products, to respond within 15 days to the agency, and to ask to schedule meetings with agency officials to discuss their tests.
FDA's core concern is that the tests should be classified as 'medical devices,' and should be regulated as such. The agency also is concerned that the companies are claiming to offer testing services that provide medical information, the validity of which FDA has not approved and which could potentially cause harm to consumers.
The firms receiving letters from FDA this week and the products named by the agency include SeqWright DNA Technology Services (Genomic Profiling Service); Interleukin Genetics (Inherent Health); Graceful Earth (Alzheimer's Test); DNATraits (Ashkenazi Jews Genetic Disease Panel); CyGene Direct (Metabolic Health Assessment DNA Analysis Test); Consumer Genetics (AsthmaGen DNA Test); Matrix Genomics (Breast Cancer Panel); The Genetic Testing Laboratories (DNA Predisposition Test); Sequenom (SEQureDx); EnteroLab Reference Laboratory (Gene Test for Gluten Sensitivity/Celiac Sprue); BioMarker Pharmaceuticals (Gene Essence); DNA Dimensions (Predisposition DNA Test); HealthCheckUSA (Celiac Disease DNA Test); EasyDNA (Genetic Predisposition Health Test).
The committee hearing in the House Subcommittee on Oversight and Investigation today is scheduled to hear from GAO officials on their investigation of the genetic testing market, from FDA on its ongoing actions, and from representatives from 23andME, Navigenics, and Pathway Genomics.