FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices

April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing (NGS) tests, as well as a draft … [Read more...]


FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests

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...]


FDA Watch: Personalized Medicine Approvals Continue to Flow

After a slow start to the year, new product business picked up significantly in the past four weeks. Here's a rundown of the key diagnostic product launches from mid-January through late … [Read more...]


FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals

For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing, i.e., promotion of medical products for additional … [Read more...]


FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway

A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including: FoundationOne's CDx (F1CDx) companion diagnostic test for solid tumors; and Memorial … [Read more...]


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...]