Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did … [Read more...]
EMERGING TESTS
Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
November 16, 2019
EMERGING TESTS
Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
November 16, 2019
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening based on their specific circumstances. The reason that the USPTF does not directly … [Read more...]
EMERGING TESTS
Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval
October 17, 2019
Next generation sequencing (NGS) data supporting resistance assessments is crucial to developing and gaining FDA clearance for new antiviral drugs and related companion diagnostic tests (CDx). Now 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...]
EMERGING TESTS
Innovation: Breathalyzer May Offer Reliable, Easier Alternative to Blood-Based Opioid Detection
October 16, 2019
Police officers, law enforcers, employers and drug testing laboratories may soon have a new tool: a breathalyzer test capable of detecting opioid drugs. Engineers and physicians from the University of … [Read more...]
EMERGING TESTS
New Study Suggests Blood Testing May Be Capable of Diagnosing PTSD
October 16, 2019
As post-traumatic stress disorder (PTSD) becomes more widespread, it may be becoming easier to diagnose. A new study suggests that it may soon be possible to detect PTSD by using a quick blood test … [Read more...]
GENETIC TESTING
Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs
September 30, 2019
The US Preventive Services Task Force (USPSTF) issued updated recommendations for BRCA-related cancer risk assessment, genetic counseling and testing in the Aug. 20 issue of the Journal of the … [Read more...]
FDA WATCH
Emerging Tests: FDA Breaks New Ground by Clearing EIA Technology-Based Lyme Assays
September 24, 2019
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]
INSIDE THE INDUSTRY
Government Report Casts Doubt on Cost-Effectiveness of Leading Genetic Colorectal Cancer Screening Test
September 24, 2019
Few of the newfangled consumer genetic testing products have had greater commercial success and visibility than Exact Science's Cologuard colorectal cancer screening test. But a troubling new … [Read more...]
EMERGING TESTS
Study Finds Liquid Biopsies More Effective than Traditional Biopsies in Detecting Cancer Drug Resistance
September 24, 2019
Liquid biopsies based on blood samples do a better job than traditional biopsies in analyzing both the genetic diversity of the patient's cancer and how tumors evolve drug resistance at the molecular … [Read more...]
