Key test growth drivers in the quarter included tuberculosis, Cardio IQ, drug monitoring, and hemapathology blood cancer testing, "all of which showed revenue growth" in Q1.
The agency addressed industry stakeholder's concerns about its proposed diagnostic regulatory framework at the American Clinical Laboratory Association's annual meeting.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
Diagnostic executives say the revenue-based excise tax has curtailed innovation and investment across the industry, and they expect a repeal would spur job creation.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
The bill would create tax credits covering half of the clinical testing expenses incurred in the development of rapid diagnostics for certain infectious diseases.
