Natera Announces National Commercial Coverage for its Fetal RhD NIPT
Natera (NASDAQ: NTRA) has secured national commercial coverage for its cfDNA Fetal RhD noninvasive prenatal test from one of the largest U.S. payors. The coverage, effective January 2025, will be available when pregnancies are at risk for alloimmunization, when paternal antigen typing is unavailable or heterozygous, and if amniocentesis is declined or not recommended.
The test, which can be performed as early as nine weeks into pregnancy, determines fetal RhD status from maternal blood samples. This is particularly significant as up to 15% of pregnant patients are RhD-negative. When a mother is RhD-negative and the fetus is RhD-positive, there's a risk of antibody development leading to hemolytic disease of the fetus and newborn.
The test is part of Natera's women's health product suite, which includes Panorama, the most ordered NIPT in the United States.
Natera (NASDAQ: NTRA) ha ottenuto la copertura commerciale nazionale per il suo test prenatale non invasivo cfDNA Fetal RhD da uno dei più grandi pagatori degli Stati Uniti. La copertura, che entrerà in vigore a gennaio 2025, sarà disponibile quando le gravidanze sono a rischio di alloimmunizzazione, quando il tipaggio dell'antigene paterno non è disponibile o è eterozigote e se l'amniocentesi è rifiutata o non raccomandata.
Il test, che può essere eseguito già a nove settimane di gravidanza, determina lo stato RhD fetale da campioni di sangue materni. Questo è particolarmente significativo poiché fino al 15% delle pazienti in gravidanza sono RhD-negative. Quando una madre è RhD-negativa e il feto è RhD-positivo, c'è un rischio di sviluppo di anticorpi che può portare a malattie emolitiche del feto e del neonato.
Il test fa parte del portafoglio di prodotti per la salute femminile di Natera, che include Panorama, il NIPT più richiesto negli Stati Uniti.
Natera (NASDAQ: NTRA) ha asegurado la cobertura comercial nacional para su prueba prenatal no invasiva cfDNA Fetal RhD de uno de los más grandes pagadores de EE. UU. La cobertura, que entrará en vigor en enero de 2025, estará disponible cuando los embarazos estén en riesgo de aloimmunización, cuando el tipado de antígeno paterno no esté disponible o sea heterocigoto, y si se rechaza o no se recomienda la amniocentesis.
La prueba, que se puede realizar tan pronto como a las nueve semanas de embarazo, determina el estado RhD fetal a partir de muestras de sangre materna. Esto es particularmente significativo ya que hasta el 15% de las pacientes embarazadas son RhD-negativas. Cuando una madre es RhD-negativa y el feto es RhD-positivo, existe un riesgo de desarrollo de anticuerpos que puede llevar a enfermedad hemolítica del feto y del recién nacido.
La prueba es parte del portafolio de salud de la mujer de Natera, que incluye Panorama, el NIPT más solicitado en los Estados Unidos.
Natera (NASDAQ: NTRA)는 미국의 가장 큰 지불자 중 하나로부터 cfDNA Fetal RhD 비침습적 산전 검사에 대한 국가 상업적 보장을 확보했습니다. 이 보장은 2025년 1월부터 시행되며, 임신이 알로면역화 위험에 처해 있을 때, 아버지의 항원 유형이 없거나 이형접합일 때, 그리고 양수천자가 거부되거나 권장되지 않을 경우에 사용할 수 있습니다.
이 검사는 임신 9주부터 수행할 수 있으며, 모체 혈액 샘플에서 태아의 RhD 상태를 결정합니다. 이는 임신한 환자의 최대 15%가 RhD-negative인 경우가 있기 때문에 특히 중요합니다. 어머니가 RhD-negative이고 태아가 RhD-positive일 경우, 항체가 형성되어 태아와 신생아의 용혈성 질병으로 이어질 위험이 있습니다.
이 검사는 Natera의 여성 건강 제품군의 일부로, 미국에서 가장 많이 주문된 NIPT인 Panorama를 포함합니다.
Natera (NASDAQ: NTRA) a obtenu une couverture commerciale nationale pour son test prénatal non invasif cfDNA Fetal RhD de l'un des plus grands payeurs des États-Unis. La couverture, qui sera effective en janvier 2025, sera disponible lorsque les grossesses présentent un risque d'allo-immunisation, lorsque le typage des antigènes paternels est indisponible ou hétérozygote, et si l'amniocentèse est refusée ou non recommandée.
Le test, qui peut être réalisé dès la neuvième semaine de grossesse, détermine le statut RhD fœtal à partir d'échantillons de sang maternels. Cela est particulièrement significatif car jusqu'à 15 % des patientes enceintes sont RhD-négatives. Lorsqu'une mère est RhD-négative et que le fœtus est RhD-positif, il existe un risque de développement d'anticorps pouvant entraîner une maladie hémolytique du fœtus et du nouveau-né.
Le test fait partie de la gamme de produits de santé des femmes de Natera, qui comprend Panorama, le NIPT le plus commandé aux États-Unis.
Natera (NASDAQ: NTRA) hat sich die nationale kommerzielle Abdeckung für seinen cfDNA Fetal RhD nicht-invasiven pränatalen Test von einem der größten Anbieter in den USA gesichert. Die Abdeckung, die ab Januar 2025 wirksam wird, ist verfügbar, wenn Schwangerschaften einem Risiko für Alloimmunisierung ausgesetzt sind, wenn der Antigentyp des Vaters nicht verfügbar oder heterozygot ist und wenn amniocentesis abgelehnt oder nicht empfohlen wird.
Der Test, der bereits ab der neunten Schwangerschaftswoche durchgeführt werden kann, bestimmt den RhD-Status des Fötus aus den Blutproben der Mutter. Dies ist besonders wichtig, da bis zu 15% der schwangeren Patientinnen RhD-negativ sind. Wenn eine Mutter RhD-negativ ist und der Fötus RhD-positiv ist, besteht das Risiko der Bildung von Antikörpern, die zu einer hämolytischen Erkrankung des Fötus und Neugeborenen führen können.
Der Test ist Teil von Nateras Produktpalette für Frauengesundheit, zu der auch Panorama gehört, der am häufigsten bestellte NIPT in den Vereinigten Staaten.
- Secured national commercial coverage from major U.S. payor
- Coverage expands access to testing nationwide
- Integration with existing successful product line (Panorama)
- Coverage doesn't begin until January 2025
Insights
The securing of national commercial coverage from a major U.S. payor for Natera's Fetal RhD NIPT test marks a significant milestone in the company's reimbursement strategy. With approximately 3.6 million births annually in the U.S. and 15% of pregnant patients being RhD-negative, this creates a potential addressable market of roughly 540,000 tests per year.
This coverage decision is particularly strategic as it complements Natera's existing leadership position with their Panorama NIPT test, creating valuable cross-selling opportunities and strengthening their comprehensive women's health portfolio. The timing of the coverage, effective January 2025, allows for immediate revenue impact in the current fiscal year.
From a market perspective, this coverage decision could accelerate adoption rates among healthcare providers who previously hesitated due to reimbursement concerns. The early testing window (nine weeks gestation) positions the test favorably against traditional management approaches and could drive preference among healthcare providers seeking early risk assessment.
The reimbursement pathway established through this coverage decision could also set a precedent for other commercial payors, potentially catalyzing broader coverage adoption. This could lead to a cascade effect in securing additional payor contracts, further expanding market access and revenue potential.
Coverage from one of the largest payors in the country expands access to fetal RhD testing for pregnant patients nationwide
Effective as of Jan. 2025, the policy notes that coverage of fetal RhD testing is available when a pregnancy may be at risk for alloimmunization, when paternal antigen typing is unavailable or heterozygous, and if a patient declines amniocentesis or it is not recommended for the pregnancy.
Up to 15 percent of pregnant patients are RhD-negative1. When the maternal blood type is RhD-negative and the fetal blood type is RhD-positive, antibodies can develop (alloimmunization) that can lead to hemolytic disease of the fetus and newborn.
Natera’s Fetal RhD NIPT can be performed as early as nine weeks gestation and determines fetal RhD status from the blood of a pregnant patient. It is offered through the Company’s women’s health suite of products, which includes Panorama, the no. 1 ordered NIPT in the
“These new policies expand access to important testing that can prevent unnecessary medical treatment in pregnancies,” said Ramesh Hariharan, PhD, General Manager of Women’s Health at Natera. “Broadening commercial coverage to include fetal RhD testing reinforces the importance of this offering and the benefits it can bring to pregnant patients nationwide.”
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, 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 validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
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 coverage and reimbursement determinations from third-party payers, or our expectations 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.
References
1. Zipursky A, Paul VK. The global burden of Rh disease. Arch Dis Child Fetal Neonatal Ed 2011;96:F84–5. (Level III)
View source version on businesswire.com: https://www.businesswire.com/news/home/20250203957122/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
FAQ
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