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
December 17, 2018
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
December 10, 2018
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
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...]
FDA
LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create
September 25, 2018
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
August 28, 2018
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
August 6, 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 Mandatory … [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...]
GENETIC TESTING
Lack of Utility Evidence Still Hampers Adoption of Pharmacogenomic Testing: Benefits Seen in the Field of Psychiatry
July 9, 2018
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...]
