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 acquisition of the Johns Hopkins spin out and its liquid biopsy ctDNA test will significantly strengthen Quest’s oncology offerings.
In addition to the usual FCA-related fare, an arrest warrant was issued for a convicted lab co-owner after he failed to show up for prison.
Lucira has fallen on hard times since it secured the first FDA EUA for an at-home COVID-19 test in November 2020.
Congress brings back controversial Trump plan scrapped by the Biden administration.
Although the law officially took effect on March 29, the FDA says it isn’t planning to enforce the new rules until October 1.
In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.
COVID-19 test makers will either have to get full marketing approval, or take the product off the market.
Labs must use the new Advance Beneficiary Notice of Noncoverage (ABN) form starting on June 30, 2023, when the old version expires.
Last week’s lone lab-related enforcement action involved a prison sentence for a woman posing as a licensed physician’s assistant.
The DOJ's 2022 Fraud Statistics Overview shows it raked in less than 50 percent of what it recovered in FY 2021.