Diagnostics Policy & Legislation

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

The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.

Lab, diagnostic and healthcare groups want Congress to enact legislation to modify PAMA and address  concerns about the way CMS collected data and established test prices.

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.