Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]
INDUSTRY BUZZ
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
December 31, 2018
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]
INDUSTRY BUZZ
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
November 19, 2018
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on … [Read more...]
INDUSTRY BUZZ
FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry
October 2, 2018
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 developed tests (LDTs). … [Read more...]
NEW PRODUCTS
FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
September 10, 2018
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting a new proposal to Congress, … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary
August 1, 2018
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 … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
July 3, 2018
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new genetic health risk (GHR) assessment tests to market. The message to GHR test … [Read more...]
INDUSTRY BUZZ
FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
May 28, 2018
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing (NGS) in vitro diagnostic (IVD) tests and devices. (See LIR, … [Read more...]
NEW PRODUCTS
FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
April 30, 2018
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...]
NEW PRODUCTS
FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests
April 23, 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...]
