On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the "Safety and Performance Based Pathway" (new Pathway), new product … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
February 25, 2019
LEGISLATION
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
January 28, 2019
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the agency's continued reliance on a regulatory regime designed not for lab tests but medical devices. … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
January 28, 2019
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
January 7, 2019
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
January 7, 2019
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
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...]
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...]
