The final determination also adds coverage for FDA-approved tests in stage III patients, and for repeat testing if patients receive a new primary diagnosis.

The listing will allow Siemens Healthineers to invest in high-growth health sectors, such as molecular diagnostics, and to acquire US-based healthcare technology startups.

Because of a statistical error in a recent study, the firm reduced test performance numbers, but it noted that the revised numbers are still far better than standard histopathology.

The decision, which the company said was made for business and financial reasons, raises questions about the viability of such tests in the face of reimbursement uncertainly.

Near-term the deal gives Quanterix a CLIA lab while securing technologies that could improve assay multiplexing and support its longer term clinical goals.