A non-invasive prenatal test (NIPT) is a maternity blood test that looks for tiny pieces of the fetus’s genetic material in the pregnant person’s bloodstream to screen for certain chromosomal conditions. It matters to investors because NIPT is a lower-risk, easy-to-administer alternative to invasive procedures, driving steady demand for testing services, lab platforms and related technologies; think of it as a widely adopted early-warning tool that can change market size and revenue predictability for healthcare firms.
nipTmedical
Non-invasive prenatal testing (NIPT) is a blood test that screens for certain genetic conditions in a fetus by examining small fragments of the baby’s DNA present in the pregnant person’s blood, avoiding invasive procedures that enter the womb. It matters to investors because test uptake, accuracy, regulatory approval, and pricing determine revenue and margins for companies offering the technology—think of NIPT as a safer, earlier health check (like a smoke alarm for genetic risk) that can drive demand and competitive dynamics in healthcare markets.
fetal fractionmedical
Fetal fraction is the proportion of genetic material in a pregnant person’s blood that comes from the fetus rather than the parent, expressed as a percentage of total cell-free DNA. It matters to investors because tests and devices that read fetal genetic signals need a sufficient fetal fraction to give reliable results, which affects product accuracy, regulatory approval, market acceptance and potential revenue — like needing a strong radio signal to hear a broadcast clearly.
aneuploidymedical
Aneuploidy is a condition in which cells have an abnormal number of chromosomes—too many or too few—like a deck of cards missing or repeating certain cards. It matters to investors because it underlies many cancers and genetic disorders, affects how diseases progress, and can determine whether diagnostic tests or drugs work; treatments targeting aneuploidy or tests that detect it can drive clinical value and commercial opportunities.
trisomy 21medical
Trisomy 21 is a genetic condition where a person has an extra copy of chromosome 21, causing a range of developmental and health differences commonly known as Down syndrome. For investors, it matters because medical tests, therapies, and long‑term care services targeting this condition involve regulatory review, potential market demand, and reimbursement decisions; think of it as a defined patient group with specific healthcare needs that shapes product development and commercial opportunity.
trisomy 18medical
A genetic condition caused by an extra copy of chromosome 18 that disrupts normal development and often leads to severe health problems and high infant mortality. For investors, it matters because it drives demand for prenatal screening, diagnostic tests, specialized neonatal care and any therapies or medical devices aimed at managing rare, severe birth conditions—similar to how a single misprinted page can change the outcome of an entire recipe, creating market needs across diagnostics, treatment and support services.
trisomy 13medical
Trisomy 13 is a genetic condition where a baby is born with an extra copy of chromosome 13, causing widespread developmental problems and a high risk of early death; think of it as an extra page in a building blueprint that leads to critical construction errors. For investors, it matters because the condition shapes demand for prenatal screening, genetic testing, specialty treatments, and supportive care services, affecting market opportunities and regulatory attention in biotech, diagnostics, and healthcare sectors.
deep sequencingtechnical
Deep sequencing is a laboratory method that reads the genetic code many times over to detect even rare variations, like photographing the same page of a book dozens of times to catch smudges you might miss on one glance. For investors, it matters because deeper, more precise genetic data can improve diagnostics, drug development and monitoring, reduce clinical risk through better decision-making, and create commercial opportunities in diagnostics and personalized medicine.
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Study provides prospective, clinically-validated performance data at challenging low fetal fraction levels, raising industry standard
Reduces no-call rate to 0.5%, enabling results for more patients and closing a key competitive gap
AUSTIN, Texas--(BUSINESS WIRE)--
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced a major enhancement to its Panorama non-invasive prenatal test (NIPT). Powered by the company’s novel SNP-informed deep sequencing technology, Panorama NIPT is now backed by clinically-validated performance data in samples with low fetal fraction, enabling a no-call rate of 0.5%.
Fetal fraction refers to the proportion of placental DNA circulating in a pregnant patient’s blood sample. Low fetal fraction can make it more difficult to accurately detect chromosomal abnormalities in prenatal screening. Patients with low fetal fraction are associated with a significantly increased risk of aneuploidy.
Prior literature highlights challenges with sensitivity at low fetal fractions with some counting-based NIPT methods, with one study indicating 62% sensitivity for trisomy 21 at low fetal fraction.1,2 Despite this limitation, most counting-based NIPTs routinely provide results at low fetal fraction without providing clinical performance data specifically for these populations.
To address this unmet need, Natera developed and validated SNP-informed deep sequencing technology to improve NIPT performance at low fetal fractions while preserving the unique advantages of Panorama’s SNP-based methodology.
Panorama with SNP-informed deep sequencing technology is supported by a prospective, blinded clinical validation study of 3,323 high- and low-risk pregnant patients, including 242 samples with low fetal fraction or that would not have received a result otherwise. All samples had outcomes confirmed by diagnostic genetic testing. While most counting-based NIPT studies report blended performance across fetal fractions, thereby obscuring performance at low fetal fractions, results from this study demonstrated strong clinical performance explicitly in patients at low levels of fetal fraction, including 100% sensitivity for trisomy 21, 93.3% sensitivity for trisomy 18, and 100% sensitivity for trisomy 13. In addition, the no-call rate was reduced to just 0.5%, enabling more patients to receive actionable results on the first draw and removing a historical competitive gap for Panorama.
“Low fetal fraction has remained one of the most important challenges in non-invasive prenatal screening,” said Sheetal Parmar, M.S., CGC, SVP of Medical Affairs, Women’s Health. “Panorama now combines the power of our proprietary SNP-based approach with a novel deep sequencing technology that maintains strong clinical performance even in low fetal fraction samples. Importantly, we can help more patients receive reliable results without added complexity for providers.”
References
Wright et al. Ultrasound Obstet Gynecol. 2015;45(1):48-54.
Canick et al. Prenat Diagn. 2013; 33: 667-674.
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
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, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our 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.
