Clinical OMICs - Volume 3, Issue 9 - 22

Developers Face Chilly Regulatory Climate D evelopers of personal genetic tests must navigate a regulatory climate chilly enough for several to be challenged by the FDA on whether their tests require 510(k) clearance. "What we tell companies is, 'You're going to have to come in to FDA if what you're offering really is a diagnostic test.'" said Nancy K. Stade, J.D., a partner with the law firm Sidley Austin and a former deputy director for policy at FDA's Center for Devices and Radiological Health. "The challenge for coming into FDA is, there hasn't been too much of a precedent. Trying to divine what FDA is going to expect in an application is also very challenging, although it can be done." 23andMe last year won FDA's first DTC test approval, for a Bloom syndrome carrier status test, after the agency forced it in 2013 to stop selling its Saliva Collection Kit and Personal Genome Service (PGS), and submit to review as a medical device. Over the past year, the FDA has raised the prospect of 510(k) reviews for several companies that market genetic tests direct to consumers including: * DNA4Life, for its $249 Pharmacogenetic Report designed to predict patient response to more than 120 commonly-prescribed medications. * DNA-CardioCheck, for its $450 namesake test intended to test for markers linked to thrombophia, deep vein thrombosis, cardiovascular disease, and stroke. * SureGenomics, for its $2,500 SureDNA whole genome sequencing service * Interleukin Genetics, for its $169 PerioPredict, Osteoarthritis and weight management genetic tests. * Pathway Genomics, for its CancerIntercept Detect test. Pathway addressed agency concerns by making its test doctor-ordered, and "also limited the claims of what their test does to ones that seem to be more in line with the current available evidence," FDA spokeswoman Angela Stark told ClinicalOMICs. "The agency supports the development of innovative tests that may provide consumers with direct access to genetic information that can inform 22 Clinical OMICs September 2016 23andMe cleared FDA hurdles and is delivering 39 carrier status reports to its clients. health-related decisions." The FDA would not discuss its letters to the other companies. Representatives for DNA4Life, DNA-CardioCheck, and Sure Genomics were unavailable at deadline, though DNA4Life and Sure Genomics have said publicly they believe they comply with FDA rules. Interleukin Genetics referred Clinical OMICs to an April 5 statement saying the osteoarthritis test is no longer marketed, and that it changed its distribution for the weight-focused Bone Health and Heart Health tests from DTC to healthcare provider-ordered. FDA's Office of In Vitro Diagnostics and Radiological Health decided that PerioPredict-which identifies individuals at increased risk for severe periodontitis-was a laboratory developed test (LDT), and can be marketed without prior authorization, subject to agency enforcement discretion. FDA plans to exercise that discretion over DTC diagnostics, issuing draft guidance in 2014 that defines "high-risk" LDTs as Class III medical devices. The FDA has said it will finalize its guidance this year. In July, the agency issued draft guidances on next generation sequencing-based in vitro diagnostic tests. "A guidance on recommendations for DTC NGS tests could be considered," Stark said. www.clinicalomics.com http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9