Natera Clinical Study Validates New Biomarker for Aneuploidy and Adverse Pregnancy Outcomes

SAN CARLOS, Calif., Aug. 7, 2018 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing, today announced new study results demonstrating that fetal fraction, as measured by Panorama^® non-invasive prenatal testing (NIPT), can be used as an independent biomarker to screen for certain chromosome abnormalities and adverse pregnancy outcomes. Fetal fraction is the proportion of fetal DNA in the mother’s blood, and it is known to increase with gestational age and to decrease with greater maternal weight.

A recent review published in the New England Journal of Medicine¹ highlighted the increased risk of false negative results from NIPT tests that fail to measure fetal fraction. Furthermore, additional studies have shown a higher rate of certain chromosomal abnormalities in pregnancies with low fetal fraction.^2.3 In the new clinical study, published in Ultrasound in Obstetrics & Gynecology,⁴ Natera statisticians leveraged data from a subset of the over 1 million Panorama tests performed to date to devise an algorithm that flags cases where the fetal fraction is unexpectedly low, given the patient’s weight and gestational age. This proprietary algorithm computes a "Fetal Fraction Based Risk" (FFBR) score for the pregnancy.

The clinical validation study⁴ evaluated outcomes from 1,148 pregnancies with low fetal fraction. Study results showed that the new FFBR algorithm successfully identified a subgroup of high-risk cases, of which 21.8% had a chromosome abnormality or adverse outcome, representing the vast majority of all abnormalities in the cohort. Furthermore, most of these abnormalities would typically be missed by conventional NIPTs. Cases in the study not flagged by the FFBR algorithm had no evidence of increased risk.

"Consistent with the joint ACOG and SMFM⁵ and ACMG⁶ guidelines, Panorama was the first NIPT to measure and report fetal fraction," said Kimberly Martin, M.D., publication co-author and Natera’s Senior Director and Head of Women’s Reproductive Health. "Now we can use fetal fraction as an independent biomarker to overcome some of the limitations of standard NIPT algorithms, identifying high-risk pregnancies at low fetal fraction."

"These developments are the first fruits of an initiative to learn from our vast cohort of patients, further extending Natera’s leadership position by enhancing the information we can deliver," said Matthew Rabinowitz, Ph.D., Natera’s CEO. "We look forward to exploring the power of this biomarker to detect other adverse outcomes in SMART, our prospective 20,000 patient study."

About Panorama^®
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 test that differentiates between maternal and fetal DNA in the relevant chromosomes of interest. The test also screens twin pregnancies for zygosity and the gender of each baby, and identifies risk for more genetic conditions in twin pregnancies than any other NIPT.⁷ Panorama is one of several genetic screening tests designed to help families on the path to parenthood.

This test was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.

About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. Natera operates an ISO 13485-certified and CAP-accredited CLIA laboratory in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.

Forward-Looking Statements
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 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. 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 SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Barbara Sullivan, Sullivan & Associates, 714-374-6174, bsullivan@sullivanpr.com   

References

1. Bianchi DW, Chiu RWK. Sequencing of circulating cell-free DNA during pregnancy. N Engl J Med. 2018;379:464-473.
2. Pergament E, Cuckle H, Zimmermann B, et al. Single-nucleotide polymorphism-based noninvasive prenatal screening in a high-risk and low-risk cohort. Obstet Gynecol. 2014;124(2 Pt 1):210-218.
3. Norton ME, Jacobsson B, Swamy GK, et al. Cell-free DNA analysis for noninvasive examination of trisomy. N Engl J Med. 2015;372:1589-1597.
4. McKanna T, Ryan A, Krinshpun S, et al. Fetal fraction-based risk algorithm for non-invasive prenatal testing: screening for trisomy 13, 18, and triploidy in women with low cell-free fetal DNA. Ultrasound Obstet Gynecol. 2018. doi: https://doi.org/10.1002/uog.19176
5. ACOG and SMFM. Committee opinion No. 640: cell-free DNA screening for fetal aneuploidy. Obstet Gynecol. 2015;126(3):e31-37.
6. Gregg AR, Skotko BG, Benkendorf JL, et al. Noninvasive prenatal screening for fetal aneuploidy, 2016 update: a position statement of the American College of Medical Genetics and Genomics. Genet Med. 2016;18(10):1056-1065.
7. Natera validation data. Manuscript in preparation.

SOURCE Natera, Inc.