One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the target firm. Now one of those cases … [Read more...]
ENFORCEMENT
Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
April 23, 2018
LAB SAFETY
FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings
April 3, 2018
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test—23andMe's genetic health risk report for detecting BRCA1 and BRCA2 genetic mutations most commonly … [Read more...]
LAB SAFETY
FDA Watch: Extra Time for Comments on CLIA IVD Waiver Proposals
February 27, 2018
Securing CLIA waivers for in vitro diagnostic (IVD) medical devices from the FDA is a time-consuming and cumbersome process So, the FDA won rare plaudits from the industry on Nov. 29, 2017, by setting … [Read more...]
SAFETY
FDA Watch: Labs Warned that Biotin Interferes with Test Accuracy
January 17, 2018
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...]
NEW PRODUCTS
LDTs: Top 10 New FDA Diagnostic Approvals of 2017
January 17, 2018
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...]
PRECISION MEDICINE
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
December 12, 2017
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...]
PRODUCT DEVELOPMENT
FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
December 11, 2017
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...]
ENFORCEMENT
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
November 13, 2017
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...]
DISTINGUISHED SERVICE
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
October 26, 2017
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
Cutting Edge Dx Approvals Threaten FDA’s Fuddy-Duddy Reputation
September 4, 2017
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...]
