It took a while but the FDA has finally come to the realization that letting blood-based serology tests for detection of SARS-CoV-2 antibody tests into the U.S. market without requiring test makers to … [Read more...]
FDA Watch
Dozens of New COVID-19 Tests Get Emergency Clearance in April
May 8, 2020
As of April 30, 69 COVID-19 assays have received Emergency Use Authorization (EUA) from the FDA, including seven serology tests, one saliva-based test and an at-home testing kit. What began as a … [Read more...]
Emerging Tests
The FDA’s High-Stakes, High-Risk COVID-19 Serology Test Regulatory Strategy
May 2, 2020
Serology testing capable of distinguishing whether SARS-CoV-2 antibodies in a person’s systems are due to a current or previous COVID-19 infection could play a pivotal role in the re-opening process … [Read more...]
Coronavirus
Reimbursement: Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients
March 17, 2020
As labs scramble to come up with a coronavirus detection assay and CMS creates a billing and coding regimen, Congress is working to ensure that private payors provide coverage of SARS-CoV-2 testing. … [Read more...]
ACLA
Lab industry leaders meet with White House on COVID-19 testing
March 8, 2020
The American Clinical Laboratory Association (ACLA) has issued a statement following a meeting last week with the White House's Coronavirus Task Force. Here is a statement from ACLA President Julie … [Read more...]
Coronavirus
Two commercial labs testing now for COVID-19
March 8, 2020
Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it … [Read more...]
FDA
FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices
March 6, 2020
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here are the highlights. CLIA Waivers The first guidance … [Read more...]
NEW PRODUCTS
FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
February 8, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
FDA Watch
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
January 30, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
