INDUSTRY BUZZ

FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

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...]

FOCUS ON

LDTs: FDA Announces New Approach to 510(k) Approvals

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...]

GENETIC TESTING

Most Oncologists Report Using Sequencing-Based Panels In Practice

The majority of U.S. oncologists report using next-generation sequencing-based (NGS-based) tests to guide patient care, according to a study published Nov. 13 in JCO Precision Oncology, although use … [Read more...]

INDUSTRY BUZZ

FDA Watch: First NGS Residual Cancer Detection Test Wins Approval

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...]

PRECISION MEDICINE

Panel Size Affects Accuracy of Tumor Mutational Burden Calculation

Panel size is a critical determinant of test performance and cutoff values for determining the tumor mutational burden (TMB) to guide treatment decisions with immunotherapies, according to a study … [Read more...]

GENETIC TESTING

Sequencing-Based Panel May Improve Evaluation of Thyroid Nodules

A genetic test panel can help patients avoid unnecessary diagnostic thyroid surgeries, according to a study published Nov. 8 in JAMA Oncology. More than six in 10 of patients with thyroid nodules of … [Read more...]

INDUSTRY BUZZ

FDA Watch: Changes to CBER Email Policy May Affect Your Lab

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

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...]

FDA

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...]

LEGISLATION

With New FDA Input, Momentum for LDT Regulation Accelerating

In what has been called a "critical milestone" towards enacting a comprehensive new oversight framework for diagnostic tests, the U.S. Food and Drug Administration (FDA) released its comments on the … [Read more...]


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