Industry Trends

Surging COVID-19 Cases Are Pushing Laboratories to the Breaking Point

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

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

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

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

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

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

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

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...]

GENETIC TESTING

LDTs: FDA Cracks Down on Marketing of Non-Approved PGx Medication Response Tests

Laboratory Developed Tests (LDTs) are back in the FDA's enforcement crosshairs. This time the target is marketing claims related to the medication predictive qualities of pharmacogenetics (PGx) tests … [Read more...]

GENETIC TESTING

Genetics Update: Internet Use Can Help Patients Self-Diagnose Rare Genetic Disorders

The notion of empowering patients to take control over their own health care is particularly powerful within the realm of genomic diagnostics to the extent that patients can theoretically seek their … [Read more...]


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