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
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
The American Society for Gastrointestinal Endoscopy releases new recommendations for screening those with genetic susceptibility.
The company was facing allegations that it had intentionally delayed submitting lab tests in order to circumvent the rule and receive payment.
IDT will distribute the automated Biomek NGeniuS instrument in the US, Canada, UK, Sweden, Germany, France, Austria, and the Netherlands.
Agilent and Genomenon team up to bring users more effective software and search tools for making a genetic diagnosis.
Bringing the Specific Reveal Rapid AST system into the fold enhances French firm’s global position in clinical microbiology.
In this Labs in Court Weekly Roundup, all the main health care-related cases involved False Claims Act allegations or charges.
The company has successfully completed clinical trials in Israel on more than 300 women and is applying for CE marking and FDA approval.
New research shows cancer screening prevalence declined in 2020 compared to 2018, though not for all cancer types studied.
A glitch in the local run management software may open the door to hacking, agency says.
White House releases an update on the progress of the initiative to provide equitable access to COVID-19 testing and treatments in the US.