Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
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
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...
Despite COVID-19, DTC Genetic Testing Market to Be Worth $1.9B by 2026
A new report from Global Industry Analysts Inc. predicts that the global market for direct-to-consumer (DTC) genetic testing will be worth $1.9 billion US by 2026. What Is Driving the Growth of the Genetic Testing Market? The report highlights several factors...
Investment to Advance Test for Diagnosing Early Alzheimer’s Disease
ROCKVILLE, MD — The announcement of a recent investment from Semler Scientific (SMLR) in SYNAPS Dx (SDx), a privately held company focused on the research, development, and commercialization of diagnostics for neurodegenerative disorders and conditions, including...
Delivering Virtual Reality Therapeutics in Senior Care
DALLAS, TX — On Feb. 28, MyndVR, the leading provider of Virtual Reality ("VR") solutions for senior care announced a strategic partnership with Omega Healthcare Investors. As one of the largest real estate investment trusts (REITs) in senior care, Omega is...
Thermo and Symphogen Aim to Boost Biopharma Discovery
SAN JOSE, CA — On March 1, Thermo Fisher Scientific, the world leader in serving science, and Symphogen, an affiliate of and the antibody center of excellence within the international pharmaceutical company Servier, announce the continuation of their collaboration...
Cerba Research Unifies Quality Processes with Veeva Vault Quality Suite
BARCELONA, SPAIN — Veeva Systems announced March 1 that Cerba Research selected Veeva Vault Quality Suite to strengthen its laboratory and testing operations. With Vault Quality Suite, the company will advance quality for greater efficiency and compliance across...