Diagnostics Policy & Legislation

News on government policy and legislation impacting life science and diagnostics.

Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.


The list of regulated analytes needs to be reviewed and updated so that external quality controls are in place to protect patients, proficiency testing providers said.

The findings run counter to historical data and may provide fodder to reconsider current guideline recommendations on surveillance of colorectal cancer patients.

The WHO said that the list is intended to serve as a reference for countries to update or develop their own list of essential diagnostics.

Ralph Messo had previously admitted he referred patient blood specimens to Biodiagnostics in exchange for about $3,000 per month.