NEW YORK – Molecular diagnostics firm BillionToOne said Wednesday that its comprehensive genomic profiling assay Northstar Select has met the coverage criteria established by Medicare administrative contractor Palmetto, which administers the MolDx program.
Backdated to Feb. 14, eligible Medicare beneficiaries will now be able to be reimbursed for the test, which sequences cell-free DNA using an 84-gene panel to detect genomic alterations in advanced cancer that can help guide the use of molecularly targeted therapies.
The noninvasive blood test utilizes BillionToOne's patented Quantitative Counting Template technology and includes SNVs/indels, copy number alterations, and gene fusions. The assay also allows for a calculation of microsatellite instability (MSI) status.
For tests to receive coverage by Palmetto, they are required to pass a technical assessment by MolDx, which requires evidence demonstrating a test's analytical validity, clinical validity, and clinical utility. BillionToOne said that its clinical validation package included a head-to-head concordance study, which demonstrated superior sensitivity compared to other commercially available liquid biopsy tests.
According to the company, Northstar Select identified 51 percent more clinically actionable alterations in the study, most of which were present at levels below the comparators' limit of detection.
In addition to the Select test, BillionToOne — which started out in the prenatal testing market — has also developed a cancer monitoring assay called Northstar Response, which uses the same QCT technology.