The expanded coverage follows the recent guideline published by the
"The average risk NIPT market still remains highly underpenetrated; increased insurance coverage, as well as improved society guidelines, are the key drivers for unlocking volume growth and improving test economics," said
Panorama reveals a baby's risk for severe genetic disorders as early as nine weeks into pregnancy. The test uses a unique single-nucleotide polymorphism (SNP)-based technology to analyze fetal/placental DNA obtained through a blood draw from the mother. It is the only commercially available test that differentiates between maternal and fetal DNA to assess the risk of aneuploidies. The test also screens twin pregnancies for zygosity and fetal sex of each baby, and identifies risk for more genetic conditions in twin pregnancies than any other NIPT. Panorama is one of several genetic screening tests from Natera designed to help families on the path to parenthood. Natera has published 23 papers, studying over 1.3 million patients, since the launch of Panorama - the largest body of evidence in the space today.
Panorama has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the
Natera 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 women's health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers, or coverage and reimbursement determinations from third-party payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the
- Humana Noninvasive Prenatal Screening Medical Coverage Policy Number HCS-0430-025. Effective
October 22, 2020.
- ACOG Practice Bulletin Number 226: Screening for Fetal Chromosomal Abnormalities. Published
- Palomaki GE, et al.
International Society for Prenatal Diagnosis (ISPD) Position Statement: Cell free (cf)DNA screening for Down syndrome in multiple pregnancies. Prenat. Diagn. October 5, 2020. doi: 10.1002/pd.5832.
View original content to download multimedia:http://www.prnewswire.com/news-releases/nipt-for-average-risk-now-covered-for-139-million-commercial-lives-301162495.html