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...]
GUIDELINES
Ideal Age of Last Cervical Cancer Screening Depends on Test Type
November 26, 2018
With the adoption of cotesting—human papillomavirus (HPV) plus Pap cytology—cervical cancer screening methodology has focused primarily on the preferred frequency of combined testing. However, a new … [Read more...]
TESTING TRENDS
MSSA Screening Program Cuts Infections in NICUs
November 26, 2018
An active methicillin-susceptible S. aureus (MSSA) screening and decolonization program in the neonatal intensive care (NICU) unit can lead to a sustained reduction in the incidence of clinical S. … [Read more...]
TESTING STRATEGY
Penicillin Allergy Testing Underused, Could Lead to Cost Savings
November 26, 2018
Once a patient is labeled as having a penicillin allergy, it is rarely revisited. The label sticks and increases the patient's risk of receiving subsequent suboptimal, alternative antibiotic therapy, … [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...]
