LDTs: Top 10 New FDA Diagnostic Approvals of 2017

The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo, jealous of its authority and suspicious of the industry it … [Read more...]


FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests. On Nov. 6, the agency finally made a move in that direction … [Read more...]


Kellison Award goes to FDA’s Dr. Alberto Gutierrez

Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after more than 25 years of public service from his post as … [Read more...]


FDA Watch: New Moves to Boost CLIA Transparency

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...]


FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”

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...]


FDA Watch: Two More Zika Tests Get Emergency Use Authorization

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...]


FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies

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...]


FDA Watch: User Fees Dodge a Bullet, a Cancer Drug Approval Breaks New Ground and the Supreme Court Serves Up a Biosims Blockbuster

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: Congress Kills Trump Plan to ‘Recalibrate’ User Fees

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...]


FDA Watch: Doubling of User Fees, LDT Maneuvering & Potential OK for First Diabetes POC Dx Test

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...]