Natera, Inc. Obtains Z-Codes for Signatera MRD and Treatment Monitoring Test in Oncology
January 04, 2019 at 01:03 pm
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Natera, Inc. announced the assignment of two Z-codes for the company's Signatera test, in preparation for its planned clinical launch in second quarter of 2019. Signatera, when clinically available, is intended for use by oncologists to detect molecular residual disease (MRD) and monitor treatment response in cancer patients. Two Z-codes were awarded, ZB8DC and ZB8DD, representing the initial and subsequent test orders for each patient. These codes will cover multiple cancer types, as the Signatera technology has shown consistent performance across multiple cancers, including lung, breast, colorectal, and bladder.
Natera, Inc. is a diagnostics company, which is focused on the development and commercialization of molecular testing services, applying its technology in the fields of womenâs health, oncology and organ health. Its cell-free deoxyribonucleic acid (cfDNA) technology combines its molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell. The Company's product offerings include Panorama Non-Invasive Prenatal Test (NIPT), Vistara, Horizon Carrier Screening, Spectrum Preimplantation Genetics, Anora Miscarriage Test, Empower, and Prospera. The Company also offers Constellation, a cloud-based software platform that enables laboratory customers to gain access through the cloud to the Companyâs algorithms and bioinformatics in order to validate and launch tests based on the Companyâs technology. Its NIPT screens for chromosomal abnormalities of a fetus as well as in twin pregnancies, typically with a blood draw from the mother.