Policy & Legislation
News on government policy and legislation impacting life science and diagnostics.
The agency has suggested approaches like third-party review would help manage the expected influx of submissions, but labs and vendors remain concerned.
AMP Petitions Congress to Revisit CLIA Update, Eyes Legal Action Against New Proposed FDA LDT Rule
While AMP asked members to register their opposition officially, one official said "there probably will be a lawsuit."
The agency has rebuffed calls to extend its public comment period, with the upcoming election and the next user fee cycle likely influencing its timeline.
Congress Passes One-Year Delay to PAMA Implementation
Once President Biden signs the bill into law, which he is expected to do shortly, the PAMA price cuts slated for the beginning of 2024 will be put off for another year.
Labcorp Projects $80M Hit to 2024 Revenues Without PAMA Fix, Suggests Openness to FDA LDT Regulation
Premium
The company also reported Q3 revenues of $3.06 billion, up from $2.87 billion in Q3 2022 and above the consensus Wall Street estimate of $2.99 billion.