Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Liquid Biopsy Global Sales Expected to Hit $26.2 Billion by 2030
A new report projects that the worldwide market for liquid biopsy will grow from $7.1 billion in 2020 to $26.2 billion by 2030
New Microchip Could Lead To Home-Based Prostate Cancer Tests
Associate professor Kazuhiro Takahashi and Tomoya Maeda (a second-year master's student) and other members of the Department of Electrical and Electronic Information Engineering at Toyohashi University of Technology have developed a semiconductor sensor capable of...
CT Provides Safe, Accurate Diagnosis of Coronary Artery Disease
Is cardiac computed tomography (CT) as reliable as catheterization in patients with suspected coronary artery disease? Under the leadership of Charité – Universitätsmedizin Berlin, researchers from 31 European clinical institutions worked together to address this...
Monitoring Tech Dominates Recent Breakthrough Device Designations
In a quick look at U.S. Food and Drug Administration approval activity from Feb. 23 to March 7, monitoring tech makes up most of the latest breakthrough device designations achieved. Two of the three breakthrough designations announced over this period include...
Standard for Pulmonary Function Tests Gets an Update
NEW YORK, NY — March 2, 2022 — In the latest update to the pulmonary function tests technical standard series, the American Thoracic Society and European Respiratory Society address the uncertainty around the interpretation of the tests which are essential in...
Single Test for Over 50 Genetic Diseases to Accelerate Diagnosis
A new DNA test, developed by researchers at the Garvan Institute of Medical Research in Sydney and collaborators from Australia, UK, and Israel, has been shown to identify a range of hard-to-diagnose neurological and neuromuscular genetic diseases quicker and...
Healthy Market Outlook for Smart Inhalers, Report Says
Smart inhalers could be a key solution to the drawbacks of current options on the market, which many people with respiratory disorders do not use correctly. According to analysis released by Persistence Market Research at the end of 2021, the smart inhalers...
FDA Cracks Down on Unauthorized SARS-CoV-2 Rapid Antigen Tests
The FDA continues to sound the warning on unauthorized SARS-CoV-2 rapid antigen tests. On March 1, the agency issued a trio of Safety Communications warning providers and consumers not to use: The Celltrion DiaTrust COVID-19 Ag Rapid Test—the one that comes in a...
FDA Expands EUA for High-Throughput SARS-CoV-2 Real-Time PCR Assay
CARLSBAD, CA — ChromaCode, Inc., a company redefining molecular testing through data science, announced on Feb. 23 that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new...
Study Shows Utility of Blood Test for Prostate Cancer Risk Assessment
CLEVELAND, OH — Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, recently announced the publication of a large real-world clinical utility study in Urology...
