Clinical Validation Study on Natera’s Fetal RhD NIPT Published in Obstetrics & Gynecology
Natera (NASDAQ: NTRA) announced the publication of its clinical validation study on the Fetal RhD noninvasive prenatal test (NIPT) in Obstetrics & Gynecology. This study, the largest of its kind in the U.S., demonstrated high performance metrics with 100% sensitivity and 99.3% specificity. The study involved 655 RhD-negative pregnant patients, confirming fetal RhD status via newborn serology. Key results included 356/356 fetuses correctly identified as RhD positive and 295/297 as RhD negative. The test also showed a positive predictive value of 99.4% and a negative predictive value of >99.9%. The study emphasized the test's potential to assist in the prevention and management of RhD alloimmunization, especially amid RhIg shortages. The NGS-based test can identify RHD pseudogene and hybrid variants common in non-European ancestries. Experts highlight the test's potential to transform care for RhD-negative pregnant patients, aligning with ACOG's guidance on cfDNA screening for fetal RhD testing.
Natera (NASDAQ: NTRA) ha annunciato la pubblicazione del suo studio di validazione clinica sul test non invasivo prenatale Fetal RhD (NIPT) in Ostetricia e Ginecologia. Questo studio, il più grande del suo genere negli Stati Uniti, ha dimostrato metriche di prestazione elevate con una sensibilità del 100% e una specificità del 99,3%. Lo studio ha coinvolto 655 pazienti in gravidanza con RhD negativo, confermando lo stato RhD fetale tramite siero neonatale. I risultati chiave hanno incluso 356/356 feti correttamente identificati come RhD positivi e 295/297 come RhD negativi. Il test ha inoltre mostrato un valore predittivo positivo del 99,4% e un valore predittivo negativo superiore al 99,9%. Lo studio ha sottolineato il potenziale del test di assistere nella prevenzione e gestione dell'alloimmunizzazione RhD, specialmente in un contesto di carenza di RhIg. Il test basato su NGS può identificare il pseudogene RHD e varianti ibride comuni nelle ancestrali non europee. Gli esperti evidenziano il potenziale del test di trasformare la cura per le pazienti gravide RhD negative, in linea con le linee guida dell'ACOG sullo screening cfDNA per il test RhD fetale.
Natera (NASDAQ: NTRA) anunció la publicación de su estudio de validación clínica sobre la prueba prenatal no invasiva Fetal RhD (NIPT) en Obstetricia y Ginecología. Este estudio, el más grande de su tipo en los EE. UU., demostró métricas de rendimiento altas con 100% de sensibilidad y 99.3% de especificidad. El estudio involucró a 655 pacientes embarazadas RhD negativas, confirmando el estado RhD fetal a través de la serología neonatal. Los resultados clave incluyeron 356/356 fetos correctamente identificados como RhD positivos y 295/297 como RhD negativos. La prueba también mostró un valor predictivo positivo del 99.4% y un valor predictivo negativo superior al 99.9%. El estudio enfatizó el potencial de la prueba para ayudar en la prevención y manejo de la aloimmunización RhD, especialmente en medio de la escasez de RhIg. La prueba basada en NGS puede identificar el pseudogén RHD y variantes híbridas comunes en ancestros no europeos. Los expertos destacan el potencial de la prueba para transformar la atención de las pacientes embarazadas RhD negativas, alineándose con las guías de ACOG sobre el cribado de cfDNA para el testeo fetal RhD.
Natera (NASDAQ: NTRA)는 산부인과에서 태아 RhD 비침습적 태아 검사(NIPT)의 임상 검증 연구 발표를 알렸습니다. 이 연구는 미국에서 가장 큰 연구로, 100% 민감도와 99.3% 특수도를 보여주는 높은 성능 지표를 입증했습니다. 연구는 RhD 음성인 655명의 임신 환자를 포함하였으며, 신생아 혈청을 통해 태아 RhD 상태를 확인했습니다. 주요 결과로는 356/356 태아가 RhD 양성으로 올바르게 식별되었고, 295/297 태아가 RhD 음성으로 확인되었습니다. 이 검사는 또한 99.4%의 양성 예측 값과 99.9% 이상의 음성 예측 값을 보였습니다. 연구는 RhIg 부족 상황에서 RhD 면역화의 예방 및 관리에 도움을 줄 수 있는 검사 잠재력을 강조했습니다. NGS 기반 검사는 비유럽 조상의 공통 RHD 유사 유전자 및 하이브리드 변이를 식별할 수 있습니다. 전문가들은 RhD 음성 임신 환자의 치료를 혁신할 수 있는 검사의 잠재력을 강조하며, 태아 RhD 검사를 위한 cfDNA 선별에 대한 ACOG의 지침과 일치하고 있습니다.
Natera (NASDAQ: NTRA) a annoncé la publication de son étude de validation clinique sur le test prénatal non invasif Fetal RhD (NIPT) en obstétrique et gynécologie. Cette étude, la plus grande de son genre aux États-Unis, a démontré des indicateurs de performance élevés avec une sensibilité de 100% et une spécificité de 99,3%. L'étude a impliqué 655 patientes enceintes RhD négatif, confirmant le statut RhD fœtal par sérologie néonatale. Les résultats clés comprenaient 356/356 fœtus correctement identifiés comme RhD positifs et 295/297 comme RhD négatifs. Le test a également montré une valeur prédictive positive de 99,4% et une valeur prédictive négative supérieure à 99,9%. L'étude a souligné le potentiel du test pour aider à la prévention et à la gestion de l'allo-immunisation RhD, en particulier en période de pénurie de RhIg. Le test basé sur le NGS peut identifier les pseudogènes RHD et les variantes hybrides courantes chez les ancêtres non européens. Les experts soulignent le potentiel du test pour transformer les soins aux patientes enceintes RhD négatives, s'alignant sur les recommandations de l'ACOG concernant le dépistage cfDNA pour les tests RhD fœtaux.
Natera (NASDAQ: NTRA) gab die Veröffentlichung seiner klinischen Validierungsstudie zum nicht-invasiven Pränataltest Fetal RhD (NIPT) in der Gynäkologie und Geburtshilfe bekannt. Diese Studie, die größte ihrer Art in den USA, zeigte hohe Leistungskennzahlen mit 100% Empfindlichkeit und 99,3% Spezifität. An der Studie nahmen 655 RhD-negative schwangere Frauen teil, deren fetaler RhD-Status durch Neugeborenenserologie bestätigt wurde. Zu den wichtigsten Ergebnissen gehörten 356/356 Feten, die korrekt als RhD-positiv identifiziert wurden, sowie 295/297, die als RhD-negativ identifiziert wurden. Der Test zeigte zudem einen positiven prädiktiven Wert von 99,4% und einen negativen prädiktiven Wert von über 99,9%. Die Studie betonte das Potenzial des Tests, bei der Prävention und Behandlung der RhD-Alloimmunisation zu unterstützen, insbesondere angesichts von RhIg-Mangel. Der NGS-basierte Test kann RHD-Pseudogene und hybride Varianten identifizieren, die in nicht-europäischen Abstammungen häufig sind. Experten heben das Potenzial des Tests hervor, die Betreuung von RhD-negativen schwangeren Frauen zu transformieren, was mit den Empfehlungen der ACOG zur cfDNA-Screening für die fetale RhD-Testung übereinstimmt.
- High performance metrics: 100% sensitivity and 99.3% specificity.
- Largest clinical validation study of a fetal RhD test in the U.S.
- Potential to prevent RhD alloimmunization amid RhIg shortages.
- Positive predictive value of 99.4% and negative predictive value of >99.9%.
- Approximately 40% of patients with an RhD-negative fetus receive RhIg unnecessarily.
Insights
The clinical validation study for Natera's Fetal RhD NIPT represents a significant advancement in prenatal testing. With 100% sensitivity and 99.3% specificity in a substantial cohort of 655 patients, these performance metrics are exceptional for a diagnostic test. The study's inclusion of diverse racial and ethnic backgrounds enhances its clinical applicability.
The test's ability to identify RHD pseudogene variants is particularly valuable for non-European populations, addressing an important gap in current testing capabilities. The 40% reduction in unnecessary RhIg administration could significantly impact healthcare resource utilization, especially important during medication shortages.
For Natera's business outlook, this validation strengthens their position in the prenatal testing market, complementing their leading Panorama test. The publication in a prestigious journal (The Green Journal) adds credibility and could accelerate clinical adoption.
Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of
Natera’s study is the largest clinical validation of a fetal RhD test performed in
Key highlights of the study include:
-
356/356 fetuses were correctly identified as fetal RhD positive (sensitivity:
100% [95% CI: 98.9-100.0]). -
Of the 297 RhD-negative fetuses, 295 were correctly identified as RhD-negative (specificity of
99.3% [95% CI: 97.6-99.8]). -
Positive predictive value for the test was
99.4% and negative predictive value was >99.9% . -
The study included a representative mix of race and ethnicities in the RhD-negative
U.S. population.
RhD alloimmunization, which can lead to hemolytic disease of the fetus and newborn, can occur when an RhD-negative patient carries an RhD-positive fetus. Historically, this risk is well managed by giving Rho(D) immune globulin therapy (RhIg). However, approximately
“This large clinical validation study demonstrated excellent performance in identification of fetal RhD status,” said Marisa Gilstrop Thompson, M.D., a board-certified physician in Maternal Fetal Medicine, Obstetrics and Gynecology, and Clinical Genetics with the Delaware Center for Maternal and Fetal Medicine of Christiana Care. “Access to highly accurate fetal RhD testing has the potential to transform the care of RhD-negative pregnant patients.”
“Supporting reproductive health has long been part of Natera’s mission, and we are proud to offer this noninvasive, highly accurate cfDNA test to help clinicians prevent potential complications in future pregnancies,” said Sheetal Parmar, MS CGC, Natera’s senior vice president of medical affairs for women’s health.
The RhD test is an offering within Natera’s women’s health suite of products, which also includes Panorama, the No. 1 ordered noninvasive prenatal test in the
About Panorama
Panorama screens 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 maternal blood draw. It is the only commercially available NIPT that differentiates between maternal and fetal DNA to assess the risk of aneuploidies. Panorama has been the subject of more than 40 peer-reviewed publications of over 2 million patients. 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 US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
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
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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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