Business
Medicare Issues Positive Draft Local Coverage Determination for Natera's Signatera(TM) MRD Test in Colorectal Cancer
SAN CARLOS, Calif., Aug. 22, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that the Palmetto
About this update from Natera, Inc.
[{"type":"text","content":"\n \n \n SAN CARLOS, Calif., Aug. 22, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that the Palmetto MolDX program has proposed a local coverage determination (LCD) for use of Natera's Signatera molecular residual disease (MRD) test in patients with certain forms of colorectal cancer (CRC). There are estimated to be 145,600 new CRC diagnoses per year in the U.S., and over 1 million CRC survivors.1\n\n \nThe draft LCD proposes coverage for two situations:\nPatient stratification after surgical resection, where decisions regarding the need for chemotherapy will incorporate the presence or absence of residual disease as determined by Signatera. Recurrence detection in patients with a previous cancer diagnosis but no ongoing clinical evidence of disease. Testing frequency to be in line with current NCCN guidelines on surveillance using carcinoembryonic antigen testing (CEA).\"Patients diagnosed with CRC stand to gain significantly from access to Signatera,\" said Alexey Aleshin, M.D., M.B.A., Natera's Senior Medical Director of Oncology. \"MRD testing can optimize use of adjuvant chemotherapy and detect recurrence at an earlier and possibly curable stage.\" \nThe LCD highlights published studies where Signatera MRD status was the only factor significantly associated with relapse-free survival after adjusting for all other standard clinicopathological factors, and where Signatera detected relapse up to 16.5 months earlier (average 8.7 months earlier) than standard diagnostic tools including CT imaging and CEA.2 It is estimated that the majority of recurrences are currently diagnosed after surgical resection is no longer an option.\n\"We are very pleased with this proposed LCD,\" said Solomon Moshkevich, Natera's General Manager of Oncology and Transplant. \"Signatera is a breakthrough diagnostic technology, and we look forward to working with Medicare and the oncology community to enable patient access first in colorectal cancer and soon in other cancer types.\"\nThe draft LCD is posted here on the Centers for Medicare and Medicaid Services website and is subject to a public comment period before it is finalized.\nAbout NateraNatera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on repr...