PRECISION MEDICINE

Panel Size Affects Accuracy of Tumor Mutational Burden Calculation

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...]

GENETIC TESTING

Sequencing-Based Panel May Improve Evaluation of Thyroid Nodules

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

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

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

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

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

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

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

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

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...]


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