The criticism leveled at the Food and Drug Administration (FDA) over the lack of diagnostic tests for COVID-19 in the U.S. belies the unprecedented speed with which new coronavirus tests are reaching … [Read more...]
Employment Law
Coronavirus pushing rapid changes in employer law
March 30, 2020
By Mike O’Brien bio Employer law is rapidly changing amid the coronavirus pandemic. For one thing, Congress has passed another coronavirus related law. The United States Department of Labor (DOL) … [Read more...]
Daily Update
FDA Approved Coronavirus Tests
March 30, 2020
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION (As of April 2, 2020) Yesterday, North Carolina-based Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test became the first coronavirus serology … [Read more...]
Emerging Tests
How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed
March 24, 2020
The criticism leveled at the Food and Drug Administration (FDA) over the lack of diagnostic tests for COVID-19 in the U.S. belies the unprecedented speed with which new coronavirus tests are reaching … [Read more...]
FDA Watch
SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals
March 24, 2020
Key new U.S. Food and Drug Administration product approvals announced from mid-February 2020 through March 20, 2020 include emergency use authorization (EUA) for eight different commercial tests for … [Read more...]
Testing Trends
USPSTF Recommends Hepatitis C Virus Infection Screening for All Adults
March 23, 2020
In response to a spike in hepatitis C virus (HCV) infection cases among young adults, the U.S. Preventive Services Task Force (USPSTF) revised its guidance and is now recommending that all adults, not … [Read more...]
Genetic Tests
New NCCN Recommends Biomarker Prostate Cancer Testing for Intermediate- & High-Risk Men
March 23, 2020
With all the COVID-19 hullabaloo, a potentially significant development in genetic prostate cancer testing has flown under the radar. It happened on March 16, when the National Comprehensive Cancer … [Read more...]
FDA Watch
FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
March 23, 2020
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA … [Read more...]
