At-home specimen collection for SARS-CoV-2 diagnostic testing requires a leap of faith, namely, that patients can do an adequate job of self-collecting the nasal and nasopharyngeal samples on which … [Read more...]
Emerging Tests
New Study Supports Accuracy of COVID-19 Testing on Self-Collected Nasal Samples
June 25, 2020
Diagnostic Breakthroughs
Researchers Develop Scalable Antibody Test to Detect COVID-19 Immunity
June 23, 2020
Scalable, accurate assays capable of not only COVID-19 detection but actual immunity to the virus will be critical for social distancing, virus surveillance and treatment. And now researchers at the … [Read more...]
Emerging Markets
After Early Skepticism, FDA Warms to At-Home Sample Collection for COVID-19 Testing
June 1, 2020
Even before the pandemic began, concerns over the marketing of fraudulent home testing kits had been a sore spot with the FDA. So, when the agency first began to roll out its liberalized clearance … [Read more...]
FDA Watch
After Initial Resistance, Agency Warms to Home COVID-19 Testing
May 27, 2020
Back in March, the US Food and Drug Administration (FDA) stated that the newly liberalized clearance scheme it was deploying to expedite the COVID-19 diagnostic testing pipeline did not apply to … [Read more...]
Emerging Tests
FDA Pulls Back the Reins on Makers of Unproven Coronavirus Serology Assays
May 27, 2020
The U.S. Food and Drug Administration continues to struggle in its quest for a regulatory policy to unlock the potential of blood-based COVID-19 serology testing while reining in fraudulent marketing … [Read more...]
COVID-19 Serology Testing
Now Even the “Good” Tests Are Coming Under Fire
May 26, 2020
The inaccuracy of serology tests that detect antibodies to the SARS-CoV-2 virus has become an issue of mounting concern. Even though the lack of sensitivity and specificity of these tests is well … [Read more...]
Emerging Tests
SARS-CoV-2 Antigen Testing Is Here but Is It Really a ‘Game Changer’
May 25, 2020
First came the molecular and then the serological assays. And now a third kind of coronavirus testing methodology has made its official US debut: antigen tests. Some have hailed this development as a … [Read more...]
Diagnostic Deals
How Curative & KorvaLabs Created a Successful COVID-19 Testing Lab in Less than a Month
May 8, 2020
Say what you will about the current state and availability of COVID-19 diagnostic testing, the energetic, imaginative and speedy response by certain segments of the lab industry has been nothing short … [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 Markets
The Money to Be Made on New SARS-CoV-2 $erology Test Products
May 2, 2020
SARS-CoV-2 serology antibody testing—reliably indicating whether persons with SARS-CoV-2 have COVID-19 or had COVID-19 and are thus presumably immune from getting it again—has the potential to provide … [Read more...]
