The Centers for Medicare & Medicaid Services (CMS) has signed off on Natera’s molecular residual disease (MRD) test for two new cancer indications, broadening access to the test to more US patients.
Natera’s Signatera test is now covered in ovarian cancer, with further coverage added in breast cancer. This adds to previous indications including colorectal cancer and muscle-invasive bladder cancer.
US-based Natera stated that ovarian cancer is covered in the adjuvant and surveillance setting while breast cancer has been approved in the neoadjuvant setting. The determinations were made through the CMS’s molecular diagnostics services programme (MolDX).
Signatera is a personalised MRD test that uses circulating tumour DNA to detect and quantify cancer left in the body. MRD tests are used in patients previously diagnosed with cancer to see whether treatment has been successful.
Natera’s test was validated in ovarian cancer by a study involving 163 plasma samples from 69 patients at stage I-IV of the disease. With longitudinal testing, recurrence was detected with 100% sensitivity and 100% specificity. The company reported an average lead time of ten months ahead of imaging.
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