FDA Watch: Labs Warned that Biotin Interferes with Test Accuracy

In late November, the FDA issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with lab testing results. Biotin Concerns… Over-the-counter (OTC) use … [Read more...]


LDTs: Top 10 New FDA Diagnostic Approvals of 2017

While the FDA remains glacial in its tempo, jealous of its authority and suspicious of the industry, it is also, ever so slowly, changing its ways. While the new administration's dedication to cutting … [Read more...]


Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Using Nuclear Stress Tests as Screening Procedure = Medical Necessity Violation Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing … [Read more...]


FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval

The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to lab tests, the policy … [Read more...]


FDA Watch: Agency Moves to Boost CLIA Waiver 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...]


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...]


Cutting Edge Dx Approvals Threaten FDA’s Fuddy-Duddy Reputation

A trio of recent FDA product approvals in the diagnostics space have belied the agency's traditional reputation for resisting medical innovation. Here's the timeline for what has become an exciting … [Read more...]


FDA Approves First NGS Oncology Companion Dx for Multiple Therapies

In May, the U.S. Food and Drug Agency (FDA), the agency known for its stinginess in approving new products, broke new ground by approving Merck's Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor, a … [Read more...]


FDA Speeding Approval Process, Continued User Fees Needed

The U.S. Food and Drug Administration (FDA) has been chronically plagued with understaffing, an ever expanding workload and criticism over how long the agency takes to issue approvals. And the new … [Read more...]


FDA Sends 14 Warning Letters Regarding Cancer Products

The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]