The cell collection device already has FDA clearance, while the firm intends to conduct trials in support of a filing for marketing clearance of the assay.
Questions posed by CMS about expanding PAMA data collection expose a rift between labs and other industry stakeholders over who should report lab prices.
Since last year the AMA has issued 23 PLA codes for firms that want to better track use of their tests, but the effect of the codes on improving reimbursement remains to be seen.
The Human Diagnosis Project recently brought in partners in an effort to expand specialty care to underserved populations across the US and measure outcomes.
