EMERGING TESTS

Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval

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: 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...]

Innovation: Breathalyzer May Offer Reliable, Easier Alternative to Blood-Based Opioid Detection

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...]

New Study Suggests Blood Testing May Be Capable of Diagnosing PTSD

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

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

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

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

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...]

INNOVATION

Point of Care: Handheld Device Shows Promise in Detecting Concussion from Blood Samples

A handheld portable device could be more effective than a CT scan in detecting mild traumatic brain injuries (TBI), according to a new study published in The Lancet Neurology. Because it is capable of … [Read more...]

GENETIC TESTING

Genetic Testing: Multigene Panel Testing Detects Hereditary Risk Variants in Metastatic Breast Cancer Patients

The clinical value of performing multigene panel for inherited cancer in patients with metastatic breast cancer has been the subject of considerable debate. Those who believe in the value of such … [Read more...]


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