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”
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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
How to Make Genetic Testing Relevant for All Groups
Researchers propose solutions to underrepresentation of certain groups in genetic databases, based on two recent initiatives.
New Guidelines Released for Pancreatic Cancer Screening
The American Society for Gastrointestinal Endoscopy releases new recommendations for screening those with genetic susceptibility.
Caris Life Sciences Settles Medicare 14-Day Rule Claims for $2.88 Million
The company was facing allegations that it had intentionally delayed submitting lab tests in order to circumvent the rule and receive payment.
Beckman Coulter Tabs IDT to Distribute Its Biomek NGeniuS NGS System
IDT will distribute the automated Biomek NGeniuS instrument in the US, Canada, UK, Sweden, Germany, France, Austria, and the Netherlands.
New Partnership Aims to Improve Genomic Variant Interpretation
Agilent and Genomenon team up to bring users more effective software and search tools for making a genetic diagnosis.
BioMérieux Closes $416.8 Million Acquisition of Specific Diagnostics
Bringing the Specific Reveal Rapid AST system into the fold enhances French firm’s global position in clinical microbiology.
Delay in Submitting Genetic Tests Costs Life Sci Company $2.8 Million
In this Labs in Court Weekly Roundup, all the main health care-related cases involved False Claims Act allegations or charges.
Israeli Startup Salignostics Launches First Saliva-Based Pregnancy Test
The company has successfully completed clinical trials in Israel on more than 300 women and is applying for CE marking and FDA approval.
Minorities See Biggest Drops in Cancer Screening During the Pandemic
New research shows cancer screening prevalence declined in 2020 compared to 2018, though not for all cancer types studied.
FDA Warns of Cybersecurity Vulnerability in Certain NGS Instruments
A glitch in the local run management software may open the door to hacking, agency says.
