On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]
Coronavirus
Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
March 4, 2020
FDA Watch
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
January 30, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
Industry Buzz
Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
January 30, 2020
Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]
INDUSTRY TRENDS
Adoption Quickening for Genomic Cancer Testing in Community Settings
September 16, 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...]
PUBLIC HEALTH
CDC Announces Shortage of TB Skin Test Antigen, New TB Testing Guidelines
August 12, 2019
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...]
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...]
