FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response

With another hurricane season wreaking havoc, the FDA's Center for Biologics Evaluation and Research (CBER), which regulates biological products for human use, is calling on labs to pay attention to … [Read more...]


LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create

A couple of years ago, the lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory … [Read more...]


New Zika Blood Testing Guidance Effective Immediately

On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus. Summary After initially recommending universal nucleic acid testing of individual blood donation units, the … [Read more...]


FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory

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...]


FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack

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...]


Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation

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...]


New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work

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...]


Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers

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...]


FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings

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: Extra Time for Comments on CLIA IVD Waiver Proposals

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...]