Natera Announces Medicare Coverage for Prospera™ in Single Lung Transplant Recipients
Natera announced that its Prospera Lung test has received Medicare coverage from CMS's MolDX Program for single lung transplant (SLT) recipients in surveillance settings. SLT patients represent ~20% of U.S. lung transplants and face higher risks of rejection and biopsy complications. The test's performance was validated in the SLAM study, showing an AUC-ROC of 0.85 in distinguishing rejection, infection, and CLAD from stable patients, with 77.8% sensitivity, 84.6% specificity, and 96.8% NPV. Prospera Lung is now used by over half of U.S. lung transplant centers.
Natera ha annunciato che il suo test Prospera Lung ha ricevuto la copertura da Medicare attraverso il programma MolDX del CMS per i riceventi di trapianto unilaterale di polmone (SLT) in contesti di sorveglianza. I pazienti SLT rappresentano circa il 20% dei trapianti di polmone negli Stati Uniti e affrontano rischi più elevati di rigetto e complicazioni da biopsia. Le prestazioni del test sono state validate nello studio SLAM, che ha mostrato un AUC-ROC di 0.85 nel distinguere il rigetto, l'infezione e il CLAD da pazienti stabili, con una sensibilità del 77.8%, una specificità dell'84.6% e un NPV del 96.8%. Prospera Lung è ora utilizzato da oltre la metà dei centri di trapianto di polmone negli Stati Uniti.
Natera anunció que su prueba de Prospera Lung ha recibido cobertura de Medicare a través del programa MolDX de CMS para receptores de trasplante unilateral de pulmón (SLT) en entornos de vigilancia. Los pacientes SLT representan aproximadamente el 20% de los trasplantes de pulmón en EE. UU. y enfrentan mayores riesgos de rechazo y complicaciones por biopsia. El rendimiento de la prueba fue validado en el estudio SLAM, mostrando un AUC-ROC de 0.85 para distinguir entre rechazo, infección y CLAD de pacientes estables, con una sensibilidad del 77.8%, una especificidad del 84.6% y un NPV del 96.8%. Prospera Lung se utiliza ahora en más de la mitad de los centros de trasplante de pulmón de EE. UU.
네이터라는 자신의 프로스페라 폐 테스트가 감시 환경에서 단일 폐 이식(SLT) 수혜자를 위한 CMS의 MolDX 프로그램에서 메디케어 보장을 받았다고 발표했습니다. SLT 환자는 미국 폐 이식의 약 20%를 차지하며 거부와 생검 합병증의 위험이 더 높습니다. 이 테스트의 성능은 SLAM 연구에서 검증되어 안정적인 환자와의 거부, 감염 및 CLAD를 구별하는 데 AUC-ROC 0.85를 나타내며, 민감도 77.8%, 특이도 84.6%, NPV 96.8%를 기록했습니다. Prospera Lung은 현재 미국의 절반 이상의 폐 이식 센터에서 사용되고 있습니다.
Natera a annoncé que son test Prospera Lung a reçu une couverture Medicare par le biais du programme MolDX du CMS pour les receveurs de greffe unilatérale de poumon (SLT) dans des contextes de surveillance. Les patients SLT représentent environ 20 % des greffes de poumon aux États-Unis et font face à des risques plus élevés de rejet et de complications de biopsie. La performance du test a été validée dans l'étude SLAM, montrant un AUC-ROC de 0,85 pour distinguer le rejet, l'infection et le CLAD des patients stables, avec une sensibilité de 77,8 %, une spécificité de 84,6 % et un NPV de 96,8 %. Prospera Lung est maintenant utilisé par plus de la moitié des centres de transplantation pulmonaire aux États-Unis.
Natera hat bekannt gegeben, dass sein Prospera Lung-Test von Medicare im Rahmen des MolDX-Programms des CMS für Einzel-Lungen-Transplantat (SLT)-Empfänger in Überwachungssettings abgedeckt wird. SLT-Patienten machen etwa 20% der Lungen-Transplantationen in den USA aus und haben ein höheres Risiko für Abstoßung und Biopsiekomplikationen. Die Leistung des Tests wurde in der SLAM-Studie validiert, die eine AUC-ROC von 0,85 zeigte, um Abstoßung, Infektion und CLAD von stabilen Patienten zu unterscheiden, mit einer Sensitivität von 77,8%, einer Spezifität von 84,6% und einem NPV von 96,8%. Prospera Lung wird jetzt von über der Hälfte der Lungen-Transplantationszentren in den USA verwendet.
- First and only dd-cfDNA test approved by CMS for SLT patients
- Medicare coverage expansion to include single lung transplant recipients
- Strong test performance metrics (AUC-ROC: 0.85, NPV: 96.8%)
- Market penetration exceeding 50% of U.S. lung transplant centers
- None.
Insights
The Medicare coverage expansion for Prospera Lung in single lung transplant (SLT) recipients represents a significant market opportunity. With SLT patients comprising
This coverage decision is particularly valuable as it makes Natera the first and only dd-cfDNA test provider with CMS coverage for SLT patients. With over half of U.S. lung transplant centers already using Prospera Lung for double-lung transplants, this expansion creates a clear path for revenue growth in the SLT segment. The shorter median survival time of 4.7 years for SLT patients suggests a sustained need for regular monitoring, potentially translating to consistent test utilization and recurring revenue streams.
SLT patients make up ~
The performance of Prospera Lung for SLT patients was published earlier this year from the Single Lung Allograft Monitoring (a.k.a. SLAM) study, the largest study of commercial donor-derived cell free DNA (dd-cfDNA) tests in SLT to-date. The data demonstrated excellent performance for Prospera in distinguishing rejection, infection, and chronic lung allograft disease (CLAD) from stable patients with an AUC-ROC of 0.85. These results are on par with Prospera’s outstanding performance in double-lung transplants, and can ultimately provide confidence to rule out rejection, highlighted by a sensitivity of
“We are pleased to be the first and only dd-cfDNA test validated and approved by CMS for SLT patients,” said David Ross, MD, senior medical director for lung transplant at Natera. “Lung transplant survival is among the worst compared to other organs, even more so for SLT patients where the median survival is just 4.7 years post-transplant and with higher risk for both acute and chronic rejection. It is critical to patient care that SLT patients have the option for non-invasive monitoring to avoid biopsy complications in these challenging cases.”
Since the initial validation and launch in 2022, the Prospera Lung test first received CMS coverage for double-lung transplant patients in 2023 and is now used by more than half of lung transplant centers in
About Prospera
The Prospera™ test leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation.
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 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.
References
- Scientific Registry of Transplant Recipients (SRTR) Center-Specific Reports; 2021. Available at: https://www.srtr.org/reports/program-specific-reports/
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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
What Medicare coverage did Natera (NTRA) receive for Prospera Lung test in 2024?
What are the performance metrics of Natera's (NTRA) Prospera Lung test for single lung transplants?
What percentage of U.S. lung transplant centers use Natera's (NTRA) Prospera Lung test?
