American Medical Association Grants New CPT Code for Microdeletion Testing
SAN CARLOS, Calif., March 11, 2016 /PRNewswire/ — Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, announced the American Medical Association (AMA) has approved Natera's application for a Current Procedural Terminology, or CPT, code for fetal chromosomal microdeletion detection in circulating cell-free fetal DNA in maternal blood. This code will be effective January 1, 2017.
Natera submitted an application for this code in 2015. Before granting this code the AMA performed a review of the published literature on microdeletions, the technology available to screen for these disorders, and the current volume of testing.
"We are very pleased that the AMA has decided to grant a new CPT code for fetal chromosomal microdeletion detection in circulating cell-free fetal DNA in maternal blood," said Matt Rabinowitz, CEO of Natera. "We believe the AMA's action represents a critical step for strong reimbursement of microdeletions testing."
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system. Tests include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation. Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including uncertainty in the development and commercialization of Natera's planned future cancer products or other new products or if the results of its clinical studies do not support the use of its tests, or cannot be replicated in later studies required for regulatory approvals or clearances. Additional risks and uncertainties are discussed in greater detail in the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Natera's Form 10-Q for the quarter ended September 30, 2015. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company's website at www.natera.com under the Investor Relations section, and on the SEC's website at www.sec.gov.
Mike Brophy, Investor Relations, 650-249-9091 x 1471
SOURCE Natera, Inc.