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
Not disclosing list prices of uncovered lab tests on ABN is not consumer fraud, court says.
Though last week’s cases didn’t involve labs or lab testing, most were FCA-related issues including inflated claims.
Specially crafted lab tests speed up adoption of novel drug treatments.
Q4 2022 financial results released by three key lab companies over the past week mainly included losses, but there were positives as well.
Influential panel cites lack of evidence of tests’ harms and benefits.
Last week saw the usual False Claims Act and kickback-related charges, with the biggest action involving urine drug testing.
FDA will still be able to issue EUAs for COVID-19 tests after May 11.
A new method of early, multi-cancer detection could prove more effective for non-invasive screening than other emerging options.
Cost cutting and restructuring has become the order of the day for many lab companies.
While AI as a diagnostic tool is still years away from regular clinical use, recent research is an important step.