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...]

FOCUS ON

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...]

INDUSTRY BUZZ

FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary

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...]

GENETIC TESTING

Lack of Utility Evidence Still Hampers Adoption of Pharmacogenomic Testing: Benefits Seen in the Field of Psychiatry

For years it had been hoped that pharmacogenetic (PGx) testing would be a leading application for personalized medicine, but adoption of PGx testing has not lived up to its potential and remains in an … [Read more...]


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