FDA Watch

Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks

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...]

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...]

Precision Medicine

New ACOG Guidelines Recommend cfDNA-Based NIPT for All Pregnancies, Not Just Risky Ones

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...]

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...]

Market Trends

COVID-19 Fuels Massive & Sustainable Growth in Molecular Diagnostics

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

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...]

Emerging Markets

After Early Skepticism, FDA Warms to At-Home Sample Collection for COVID-19 Testing

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

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...]


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