LDTs
Absent Resolution on FDA's LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements
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After the VALID Act didn't pass, it's uncertain how the FDA will proceed, though some payors aren't waiting for the status quo to change and asking labs to submit additional validation data on cancer tests.
Top 10 Articles on 360Dx in 2022
In 2022 readers were most interested in a story about what happened to Cepheid's GeneXpert Omni, a point-of-care platform once touted by the company.
Lawmakers are still wrangling over whether to include these two key lab industry bills in an end-of-year spending package due to pass next week.
The AACC representative said that, as written, the exemption would not apply to large portions of laboratory-developed testing done at academic medical centers.
Diagnostics Developer Early is Good Raises $4M in Seed Funding
The company will use the funds to complete clinical trials for its first product, BCDx, a laboratory-developed test for early bladder cancer detection.