The U.S. Centers for Disease Control and Prevention (CDC) announced a three-to 10-month national shortage of Aplisol (Par Pharmaceuticals; Chestnut Ridge, N.Y.), one of two purified-protein derivative … [Read more...]
PUBLIC HEALTH
CDC Announces Shortage of TB Skin Test Antigen, New TB Testing Guidelines
August 12, 2019
INDUSTRY TRENDS
Adoption Quickening for Genomic Cancer Testing in Community Settings
July 22, 2019
Clinicians are increasingly using genomic cancer testing in community health care settings, although there are lingering questions about the utility of results. These are the findings of several … [Read more...]
INNOVATION
Multi-Cancer Screening Tests Are Getting Closer to Reality
July 15, 2019
The hope of developing a single blood test capable of detecting multiple types of early-stage cancer is getting closer to becoming a reality. Two hopeful players, GRAIL (Menlo Park, Calif.) and Thrive … [Read more...]
INDUSTRY TRENDS
Consumers Interested in Raw Genetic Data, Third Party Interpretation Tools
June 26, 2019
Consumers of direct-to-consumer (DTC) genetic testing download raw data at high rates and frequently use third-party interpretation (TPI) tools, according to a study published June 13 in the American … [Read more...]
INNOVATION
Rapid, Genomic-Based Surveillance IDs Aids Hospital Infection Control
May 23, 2019
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...]
