Just over a year ago, the U.S. Food and Drug Administration (FDA) granted its first Emergency Use Authorization (EUA) for a coronavirus test. On March 17, 2021, the test review process moved to a new … [Read more...]
FDA Watch
First De Novo Clearance Signals that Premarket Pathway Is Open for COVID-19 Tests
May 5, 2021
Genetic Testing
New Study Supports Use of Liquid Biopsy Technology to Bolster MRI Accuracy in Cancer Treatment
May 1, 2021
Important new evidence has emerged supporting the capabilities of liquid biopsy to enhance the accuracy of magnetic resonance imaging (MRI) for cancer diagnosis and treatment. That evidence comes from … [Read more...]
Testing Strategy
FDA to SARS-CoV-2 Test Developers: Evaluate Impact of Genetic Mutations on Test Performance
March 23, 2021
Evolution and mutation of SARS-CoV-2 virus has made COVID-19 diagnosis a moving target. On Feb. 22, 2021, the U.S. Food and Drug Administration issued new guidance telling developers of SARS-CoV-2 … [Read more...]
FDA Watch
2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19
February 21, 2021
They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more … [Read more...]
LDTs
FDA Clears Neutralizing Antibodies Detection Test for COVID-19
February 21, 2021
Innovative new COVID-19 tests continue to emerge from the pipeline. One of the novel diagnostic products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody … [Read more...]
FDA Watch
FDA Watch: Molecular Tests May Miss New SARS-CoV-2 Strains, Agency Warns
February 11, 2021
Like many viruses, the SARS-CoV-2 is a shape-shifter. And that may make it harder to detect. With this in mind, the U.S. Food and Drug Administration (FDA) is warning clinical laboratories and health … [Read more...]
FDA
Neutralizing Antibodies Detection Test for COVID-19 Gets the FDA Greenlight
January 30, 2021
Innovative new COVID-19 tests continue to emerge from the pipeline. One of the products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody Detection Kit from … [Read more...]
FDA Watch
Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit
January 6, 2021
Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for … [Read more...]
FDA Watch
Agency Authorizes First Fully At-Home COVID-19 Testing Kit
December 2, 2020
With COVID-19 cases surging, the U.S. Food and Drug Administration (FDA) made history on Nov. 17 by granting Emergency Use Authorization (EUA) to an all-in-one COVID-19 diagnostic that allows people … [Read more...]
The Business of Testing
HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19
November 24, 2020
Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [Read more...]
