The American College of Obstetricians and Gynecologists (ACOG) has revised its position on noninvasive prenatal testing (NIPT) and is now recommending prenatal aneuploidy screening for all pregnant … [Read more...]
Precision Medicine
New ACOG Guidelines Recommend cfDNA-Based NIPT for All Pregnancies, Not Just Risky Ones
August 29, 2020
LDTs
Battle of the SARS-CoV-2 Antibody Immunoassays: Only One Test Meets Both UK Sensitivity and Specificity Targets
August 12, 2020
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...]
Market Trends
COVID-19 Fuels Massive & Sustainable Growth in Molecular Diagnostics
August 7, 2020
While it may be decimating demand for most lab tests, COVID-19 is driving incredible growth in molecular testing. The global market for molecular diagnostics will top $13 billion in 2020, about $5 … [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...]
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...]
