Panel size is a critical determinant of test performance and cutoff values for determining the tumor mutational burden (TMB) to guide treatment decisions with immunotherapies, according to a study … [Read more...]
PRECISION MEDICINE
Panel Size Affects Accuracy of Tumor Mutational Burden Calculation
December 17, 2018
GENETIC TESTING
Sequencing-Based Panel May Improve Evaluation of Thyroid Nodules
December 10, 2018
A genetic test panel can help patients avoid unnecessary diagnostic thyroid surgeries, according to a study published Nov. 8 in JAMA Oncology. More than six in 10 of patients with thyroid nodules of … [Read more...]
EMERGING TESTS
At-Home, Smartphone-Based Urine Testing Now a Clinical Reality
December 3, 2018
In what has been called the "era of the medical selfie," at-home, smartphone-based urine testing is now a reality. In a short timeframe, the U.S. Food and Drug Administration (FDA) cleared … [Read more...]
INDUSTRY TRENDS
Despite 23andMe Authorization, FDA Cautious About PGx Testing
November 26, 2018
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...]
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...]
INFORMATICS
AI May Cut ‘Wrong Blood in Tube’ Errors
October 29, 2018
Machine learning-based multianalyte delta checks may be effective at identifying 'wrong blood in tube' (WBIT) errors, according to a proof-of-concept study published in the American Journal of … [Read more...]
INNOVATION
Liquid Biopsies Enable Pediatric Brain Cancer Monitoring
October 29, 2018
Liquid biopsies may enable physicians to monitor treatment effectiveness for children with brain cancer, enabling detection of progression earlier than MRI imaging, according to a small study … [Read more...]
EMERGING TESTS
Similar Driver Mutations Seen Across Metastasized Cancer
October 29, 2018
Driver mutations that are responsible for cancer growth are similar among metastases in a single patient, according to a study published Sept. 7 in Science. Thus, the authors say, a single biopsy is … [Read more...]
