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.
The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.
The bipartisan bill is backed by more than 250 organizations, but ACMG remains opposed, arguing that ordering tests is part of the practice of medicine.
