Routine genomic sequencing can identify and inform hospital infection control personnel of patient transmission events in near real-time, enhancing not only detection, but follow-up and investigation … [Read more...]
INFORMATICS
Technical Factors behind Discordant Results with Liquid Biopsies
May 23, 2019
Technical factors are a major source of variation in liquid biopsy test results, according to a study published online March 14 in the Journal of Clinical Oncology. While biological factors, … [Read more...]
TOP OF THE NEWS
Federal Effort to Control HIV Depends on Increasing Testing, Treatment Adherence
May 21, 2019
To control the spread of HIV in the United States, HIV infection must be diagnosed early and persons with HIV infection must be quickly linked to sustained care and treatment. These are the core … [Read more...]
TESTING STRATEGY
Microbiology Testing Rates Low For Hospital-Acquired Infections
April 29, 2019
The European Centre for Disease Control and Prevention (ECDC) estimates that there are 9 million cases of health care-associated infections (HAIs) across Europe each year, according to a study … [Read more...]
COMPLIANCE
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
April 15, 2019
By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]
TOP OF THE NEWS
New Federal Taskforce to Speed Implementation of Emergency Use Diagnostics
April 8, 2019
Three federal agencies announced the creation of a new taskforce to provide timely recommendations to laboratories for rapid implementation of in vitro diagnostic (IVD) assays during public health … [Read more...]
TOP OF THE NEWS
Genetic Risk of Prostate Cancer Underestimated; Testing Guidelines Miss Men With Elevated Prostate Cancer Risk
February 25, 2019
Neither guideline eligibility nor Gleason scores are reliable for predicting prostate cancer risk due to pathogenic germline variants, according to a study published Feb. 7 in JAMA Oncology. The … [Read more...]
TESTING STRATEGY
New Studies Question Utility of Gene Expression Testing for Cancers With Unknown Primary Site, Low-Risk Breast Cancer
February 25, 2019
Gene expression profiling has been making inroads into clinical cancer care, with application in cancer classification, most notably with breast cancer. Two recent studies are calling into question … [Read more...]
INDUSTRY TRENDS
Diagnostics Sector Saw Increased Investment, Exits in 2018
January 28, 2019
Life science and health care companies had a banner year in 2018, with a record-breaking year for venture capital investment, according to Silicon Valley Bank's Trends in Healthcare Investments and … [Read more...]
PRECISION MEDICINE
Newborn Sequencing Delivers Some Unanticipated Findings
January 22, 2019
Newborn genomic sequencing (NGS) can identify risk for a wide range of disorders that otherwise may not be detected, even in seemingly healthy babies, according to a study published Jan. 3 in the … [Read more...]
