A lot of pathology tests never get, or even have an application for, a CLIA waiver, as obviously it is not applicable.
PIQ had their PromarkerD CPT/PLA code approved in Jan 2023, had a licensing deal in May 2023, and got assigned a CMS price in Sept 2023, which become effective Jan 2024.
The BARDA deal seems like a flag to get the CMS coverage application supported. Would be good to have CMS pricing assigned by Feb next year. (They had the PLA code assigned in Dec 2023).
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A lot of pathology tests never get, or even have an application...
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