Shortages of the nasopharyngeal swabs used to collect respiratory samples for reverse transcription polymerase chain reaction (RT-PCR) tests has impeded the efforts of laboratories to meet the … [Read more...]
Reimbursement
Payors Gradually Increasing Coverage of Liquid Biopsies but Obstacles Remain
July 28, 2020
Gaining the acceptance of insurers and payors for new tests and testing technology is a perennial challenge for laboratories and test developers. This has been especially true with liquid biopsy … [Read more...]
Emerging Tests
New Study Supports Accuracy of COVID-19 Testing on Self-Collected Nasal Samples
June 25, 2020
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...]
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...]
