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
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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
CMS Reschedules PAMA Reporting & Adds New PLA Codes
Here are the two key CLFS changes, set to take effect on July 1, 2022, that your billing staff needs to know about.
What the Federal COVID-19 Fraud Crackdown Means for Labs
If your lab received federal relief funds from the US government during the COVID-19 pandemic, you could be at risk of FCA lawsuits.
Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs
The most recent congressional effort to pass LDT legislation may prove to be the one that finally comes to fruition.
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.
