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Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
The free online tool can set a foundation for renewed reimbursement strategies and contract negotiations with insurance carriers
A PT update went into effect on January 1, focusing on revised acceptance limits, among other modifications
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Lab scientists using testing equipment too quickly brings up training concerns in discussions at recent ADLM conference
Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Though IVD and commercial lab Q3 2023 earnings reports held promising signs, Q4 2024 and FY2023 results tell a different story.
