NEW YORK – Natera announced Tuesday that its Signatera test for molecular residual disease has met coverage requirements from the US Centers for Medicare and Medicaid Services for use in the surveillance setting with patients with non-small cell lung cancer (NSCLC).
The test is now covered under CMS's Molecular Diagnostics Services Program for patients with stage I-III NSCLC with resectable or unresectable disease in the surveillance setting. The coverage expands upon preexisting Medicare coverage of Signatera for immunotherapy monitoring, which is a common form of treatment for patients with NSCLC in both the adjuvant and metastatic settings, Natera said in a statement.
The test received coverage under Medicare administrative contractor Noridian Healthcare Solutions' local coverage determination for minimal residual disease testing for cancer.
Signatera's performance and utility in this setting was validated in three independent studies to support the coverage decision. Across the three studies, longitudinal sensitivity to extracranial recurrence ranged between 93 percent and 100 percent, while specificity ranged from 96 percent to 100 percent. The personalized, tumor-informed test uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence, and help optimize treatment decisions.
"The body of evidence continues to grow demonstrating Signatera's value in risk stratification, treatment response monitoring, and early detection of recurrence to inform treatment decisions across a broad range of cancer indications," Alexey Aleshin, Natera's corporate chief medical officer and general manager of oncology, said in a statement.
Signatera is also covered by Medicare for adjuvant and recurrence monitoring in colorectal cancer, muscle-invasive bladder cancer, breast cancer, and ovarian cancer, as well as for neoadjuvant treatment monitoring in breast cancer and pan-cancer immunotherapy monitoring.