The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect 33 variants for multiple … [Read more...]
MARKETING
Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
December 14, 2018
PUBLIC HEALTH
FDA Watch: Agency Approves New Flu Tests and Drug
December 14, 2018
As the flu season begins, the FDA has issued significant approvals of new products for diagnosing and treating the disease. New Flu Assays On October 24, Abbott announced that the FDA has granted … [Read more...]
FOCUS ON
LDTs: FDA Announces New Approach to 510(k) Approvals
December 14, 2018
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]
INDUSTRY BUZZ
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
December 13, 2018
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]
INNOVATION
LDTs: FDA Approves First NGS Residual Cancer Detection Test
December 10, 2018
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]
EMERGING TESTS
At-Home, Smartphone-Based Urine Testing Now a Clinical Reality
December 3, 2018
In what has been called the "era of the medical selfie," at-home, smartphone-based urine testing is now a reality. In a short timeframe, the U.S. Food and Drug Administration (FDA) cleared … [Read more...]
INDUSTRY TRENDS
Despite 23andMe Authorization, FDA Cautious About PGx Testing
November 26, 2018
The U.S. Food and Drug Administration (FDA) provided 23andMe (Mountain View, Calif.) authorization for the first direct-to-consumer (DTC) test for detecting genetic variants that may be associated … [Read more...]
TESTING STRATEGY
FDA Enabling New Point-of-Care Tests for Ebola Outbreak, Flu Season
November 26, 2018
Several recent U.S. Food and Drug Administration (FDA) actions are bringing point-of-care (POC) infectious disease tests closer to patient care. These recent regulatory wins are enabling more rapid … [Read more...]
INDUSTRY BUZZ
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
November 19, 2018
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on … [Read more...]
FDA
FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response
October 22, 2018
With another hurricane season wreaking havoc, the FDA's Center for Biologics Evaluation and Research (CBER), which regulates biological products for human use, is calling on labs to pay attention to … [Read more...]
