The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]
NEWS
FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”
October 2, 2017
The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the FDA Office of In Vitro Diagnostics (OIVD), announced that he will step down from … [Read more...]
NEWS
FDA Watch: Two More Zika Tests Get Emergency Use Authorization
August 28, 2017
Zika made the FDA headlines this month, with two more tests receiving emergency use authorization: Thermo Fisher Scientific's TaqPath Zika Virus Kit for the qualitative detection of Zika virus RNA … [Read more...]
NEWS
FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies
August 14, 2017
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a tumor's genomic features rather than its location in the … [Read more...]
LEGISLATION
FDA Watch: User Fees Dodge a Bullet, a Cancer Drug Approval Breaks New Ground and the Supreme Court Serves Up a Biosims Blockbuster
July 10, 2017
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and pharma companies pay to … [Read more...]
FDA WATCH
FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees
June 5, 2017
Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by $103 million, $4.665 billion in total. That includes $2.759 billion for … [Read more...]
NEWS
FDA Watch: Doubling of User Fees, LDT Maneuvering & Potential OK for First Diabetes POC Dx Test
March 31, 2017
Trump Proposes Doubling FDA User Fees The Trump 2018 budget proposal would double user fees that pharma and medical device companies pay the FDA to review their products from $1 to $2 billion. … [Read more...]
NEWS
FDA Watch: Discussion Paper Signals New Approach (Not Retreat) to LDT Regulation
January 23, 2017
After nearly two years of inactivity, things are suddenly heating up on FDA regulation of laboratory developed tests (LDTs). As promised, the agency took action on LDTs by the end of 2016—but not in … [Read more...]
EMERGING TESTS
FDA Approves Next-Gen Companion Diagnostic
January 16, 2017
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA … [Read more...]
NEWS
FDA Watch: Next-Gen Sequencing Companion Test Wins Approval
December 29, 2016
Last month, the U.S. Food and Drug Administration shelved its longawaited/ dreaded (depending on your point of view) final guidance on laboratory-developed tests. (For the details, see, LIR, Nov. … [Read more...]
