Despite 23andMe Authorization, FDA Cautious About PGx Testing

The U.S. Food and Drug Administration (FDA) provided 23andMe (Mountain View, Calif.) authorization for the first direct-to-consumer (DTC) test for detecting genetic variants that may be associated … [Read more...]


FDA Enabling New Point-of-Care Tests for Ebola Outbreak, Flu Season

Several recent U.S. Food and Drug Administration (FDA) actions are bringing point-of-care (POC) infectious disease tests closer to patient care. These recent regulatory wins are enabling more rapid … [Read more...]


6 Steps to Data-Driven Transformation

By Nir Kaldero  bio We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the Third brought … [Read more...]


One-Fourth of Myriad’s Variants of Unknown Significance Reclassified Over 10 Years

Variant reclassification following hereditary cancer genetic testing is common, according to a study published by Myriad Genetics (Salt Lake City) Sept. 25 in the Journal of the American Medical … [Read more...]


Multiplex, Point-of-Care Test for STIs Could Offer Public Health Benefits

Point-of-care (POC) testing that could simultaneously identify multiple sexually transmitted infections (STIs) could be a valuable addition to sexual health clinics, according to a U.K. study … [Read more...]


Rapid Molecular Testing Saves Hospitals Time, Money Ruling Out TB

Molecular testing facilitates faster discontinuation of respiratory isolation for individuals undergoing evaluation for active tuberculosis (TB) in U.S. hospitals, according to a study published Aug. … [Read more...]


Diagnostics Lagging for Tickborne Infections

The incidence of tickborne infections is on the rise in the United States. Yet, prevention and management of these infections are hampered by inadequate diagnostics, according to a perspective … [Read more...]


With New FDA Input, Momentum for LDT Regulation Accelerating

In what has been called a "critical milestone" towards enacting a comprehensive new oversight framework for diagnostic tests, the U.S. Food and Drug Administration (FDA) released its comments on the … [Read more...]


High-Sensitivity Troponin Test Rules Out Heart Attacks Faster

Use of a high-sensitivity cardiac troponin test (hs-cTnT) may be able to more quickly determine whether emergency department patients are having a heart attack, according to a research letter … [Read more...]


Urinary cfDNA Analysis Valuable for Urinary Tract Infections

Sequencing of urinary cell-free DNA (cfDNA) offers a comprehensive examination of bacterial and viral infections of the urinary tract and could be a valuable diagnostic tool for both kidney transplant … [Read more...]