Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [Read more...]

Emerging Tests

New Initiative Seeks to Standardize SARS-CoV-2 Antibody Tests

When the pandemic began, antibody testing was looked to as the kind of ace in the hole that would not only resolve the COVID-19 testing shortage fast and for good but also pave the way for society to … [Read more...]

COVID-19

New Study Shows Saliva-Based SARS-CoV-2 Test to Be at Least as Accurate as Swab Tests

Saliva-based tests could go a long way in relieving the supplies shortages that have hampered COVID-19 testing efforts. The question, though, is whether saliva samples yield results as accurate as … [Read more...]

Emerging Tests

COVID-19 Antigen Tests Are Ready for Mass Utilization but Antigen Test Reporting Is Not

It will take something on the order of 200 million COVID-19 screening tests per month, as opposed to the 25 million being performed currently, to safely reopen the U.S., estimates a new report from … [Read more...]

Top of the News

Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing

Free COVID-19 testing is a powerful and very compelling policy. The problem, of course, is that somebody has to pay for coronavirus testing. And the insurance companies have been designated as that … [Read more...]

COVID-19

Laboratory Organizations Ask HHS for Permission to Focus Scarce Testing Resources on those in Medical Need

With no hope that manufacturers will pick up the slack and furnish the reagents, swabs, PPE and other desperately needed COVID-19 testing supplies before the end of the year, laboratories are in the … [Read more...]

LDTs

Battle of the SARS-CoV-2 Antibody Immunoassays: Only One Test Meets Both UK Sensitivity and Specificity Targets

Several of the world’s biggest testing companies have created and secured emergency regulatory clearance for immunoassays that detect antibodies to the SARS-CoV-2 virus. But how reliable are these … [Read more...]

Reimbursement

Payors Gradually Increasing Coverage of Liquid Biopsies but Obstacles Remain

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

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

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...]


(-00000g2)