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...]
TESTING STRATEGY
FDA Enabling New Point-of-Care Tests for Ebola Outbreak, Flu Season
November 26, 2018
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...]
DATA
6 Steps to Data-Driven Transformation
November 26, 2018
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...]
INDUSTRY TRENDS
One-Fourth of Myriad’s Variants of Unknown Significance Reclassified Over 10 Years
November 19, 2018
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...]
TESTING TRENDS
Multiplex, Point-of-Care Test for STIs Could Offer Public Health Benefits
November 12, 2018
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...]
GUIDELINES
Rapid Molecular Testing Saves Hospitals Time, Money Ruling Out TB
October 1, 2018
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...]
TOP OF THE NEWS
Diagnostics Lagging for Tickborne Infections
October 1, 2018
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...]
LEGISLATION
With New FDA Input, Momentum for LDT Regulation Accelerating
August 28, 2018
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...]
TESTING TRENDS
High-Sensitivity Troponin Test Rules Out Heart Attacks Faster
August 27, 2018
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...]
INNOVATION
Urinary cfDNA Analysis Valuable for Urinary Tract Infections
July 30, 2018
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...]
