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
Centers for Disease Control and Prevention spearheads US effort to quickly increase lab testing capacity and access.
In this Q&A, Tyler Wince of Myndshft discusses the key issues labs face when it comes to benefits and prior authorization, and how technology can help.
First Special Fraud Alert in nearly two years cites six red flags of suspect arrangements with telehealth companies.
Biotin interference can lead to erroneous lab results in certain IVDs, including some troponin tests.
BioReference Health LLC and its parent company have agreed to pay $9.85 million to resolve alleged violations of the False Claims Act.
The new guidelines will likely prove highly influential with oncologists and payors.
As the outbreak continues to grow in countries that have not historically seen monkeypox cases, testing companies are stepping up.
Recent FDA Safety Communication warns of the potential of false results from other sample types when testing for the monkeypox virus.
The agency needs a plan on use of EUA authority to get lab tests to market during the next public health emergency, says the GAO.
Here are the aspects of the proposed rule most likely to have an impact on labs and the businesses that own them.