On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No Mandatory … [Read more...]
FOCUS ON
FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
June 19, 2018
In a notice for public comment issued last November, the FDA raised eyebrows by floating a proposal that would make it easier to bring new genetic health risk (GHR) assessment tests to market. The … [Read more...]
FOCUS ON
Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
June 19, 2018
Earlier this month, the FDA finalized new rules designed to relax the regulatory obstacles faced by manufacturers in commercializing new genetic health risk assessment tests. And now an earlier … [Read more...]
FOCUS ON
New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
May 14, 2018
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address those concerns by issuing a pair of … [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
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...]
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...]
