Evolution and mutation of SARS-CoV-2 virus has made COVID-19 diagnosis a moving target. On Feb. 22, 2021, the U.S. Food and Drug Administration issued new guidance telling developers of SARS-CoV-2 … [Read more...]
Testing Strategy
FDA to SARS-CoV-2 Test Developers: Evaluate Impact of Genetic Mutations on Test Performance
March 23, 2021
Testing Trends
Report Analyzes Federal Health Programs’ COVID-19 Testing Efforts in First Months of Pandemic
February 11, 2021
The COVID-19 outbreak caught the country and the world totally off guard. And even as the pandemic intensifies, the lessons from those first crucial months hold the key to managing not only … [Read more...]
Industry Trends
Surging COVID-19 Cases Are Pushing Laboratories to the Breaking Point
November 21, 2020
Long lines for testing. Shortages of critical testing supplies. Case backlogs and long reporting delays. Laboratories across the country and the patients they serve are reliving the nightmares of … [Read more...]
Emerging Tests
COVID-19 Antigen Tests Are Ready for Mass Utilization but Antigen Test Reporting Is Not
September 22, 2020
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...]
Genetic Testing
Despite Recommendations, Autism Patients Are Not Fragile X, Karyotype or CMA Testing
May 26, 2020
Whether due to lack of insurance coverage, personal preference or other reasons, patients with autism spectrum disorder (ASD) are not getting recommended genetic testing. That is the conclusion of a … [Read more...]
Testing Trends
USPSTF Recommends Hepatitis C Virus Infection Screening for All Adults
March 23, 2020
In response to a spike in hepatitis C virus (HCV) infection cases among young adults, the U.S. Preventive Services Task Force (USPSTF) revised its guidance and is now recommending that all adults, not … [Read more...]
Money Talks
Test Utilization: Payment Policies More Effective than Practice Recommendations in Curbing Orders of Low-Value Tests
March 20, 2020
When it comes to getting physicians not to order low-value laboratory tests, money talks. At least, that is the punchline of a new study finding that changes in payment policies are more effective … [Read more...]
ACMG the Latest to Come Out Against Genetic Testing for All Breast Cancer Patients
January 19, 2020
The debate over the need for genetic testing of all breast cancer patients for germline pathogenic or likely pathogenic variants in BRCA1, BRCA2 and other breast cancer-linked genes continues with the … [Read more...]
FDA WATCH
FDA Watch: Agency Resounds the Alarm on Biotin Test Interference
November 19, 2019
In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The … [Read more...]
TESTING TRENDS
Testing Trends: AMP Creates New Quality Guidelines for PGx Laboratory Testing
October 16, 2019
Pharmacogenetic (PGx) testing has recently come under fire from both the scientific and regulatory community for its lack of self-policing. But the new Association for Molecular Pathology (AMP) … [Read more...]
