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.
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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.
Signatera’s inclusion in breast cancer, which includes all subtypes of the disease, was based on evidence from the I-SPY2 trial. The trial, which analysed 1,024 plasma samples from 283 patients, demonstrated the test accurately predicted therapy response and distant recurrence-free survival.
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By GlobalDataNatera’s chief medical officer of oncology Minetta Liu said: “These important Medicare decisions support our ability to personalise disease management for patients with ovarian cancer, the most lethal gynaecologic malignancy worldwide, and extend existing coverage in breast cancer to the neoadjuvant setting.”
Last year, Natera filed a patent infringement lawsuit against CareDx, accusing the company of patent infringement. The patents involved in the lawsuit cover DNA amplification technology. The latest court case is the most recent in a long line of legal battles between the two companies.
