Savara Announces U.S. Launch of the aPAP ClearPath™ Dried Blood Spot Test to Detect Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Savara Inc. (SVRA) has launched the aPAP ClearPath™ Dried Blood Spot (DBS) Test in the U.S., advancing their diagnostic capabilities for autoimmune pulmonary alveolar proteinosis (aPAP). This new test requires only a finger-prick blood sample and has demonstrated 100% analytical sensitivity and specificity in detecting GM-CSF autoantibodies.
Developed in partnership with TrilliumBiO's CLIA-certified lab, the test is offered at no cost and provides a convenient alternative to traditional venous blood draws. The company is currently finalizing its rolling BLA submission for MOLBREEVI™, their potential first-ever FDA-approved aPAP treatment, targeted for completion by the end of Q1 2025.
aPAP is a rare lung disease where antibodies neutralize GM-CSF, preventing proper surfactant clearance in the lungs, leading to breathing difficulties and potential serious complications including lung fibrosis.
Savara Inc. (SVRA) ha lanciato il test aPAP ClearPath™ Dried Blood Spot (DBS) negli Stati Uniti, migliorando le proprie capacità diagnostiche per la proteinosi alveolare autoimmune (aPAP). Questo nuovo test richiede solo un campione di sangue prelevato da un dito e ha dimostrato 100% di sensibilità e specificità analitica nel rilevamento degli autoanticorpi GM-CSF.
Sviluppato in collaborazione con il laboratorio certificato CLIA di TrilliumBiO, il test è offerto gratuitamente e rappresenta un'alternativa comoda ai tradizionali prelievi venosi. L'azienda sta attualmente finalizzando la sua presentazione BLA rolling per MOLBREEVI™, il loro potenziale primo trattamento aPAP approvato dalla FDA, previsto per essere completato entro la fine del primo trimestre del 2025.
L'aPAP è una malattia polmonare rara in cui gli anticorpi neutralizzano il GM-CSF, impedendo una corretta rimozione del surfattante nei polmoni, portando a difficoltà respiratorie e potenziali gravi complicazioni, tra cui la fibrosi polmonare.
Savara Inc. (SVRA) ha lanzado la prueba aPAP ClearPath™ Dried Blood Spot (DBS) en los EE. UU., mejorando sus capacidades de diagnóstico para la proteinosis alveolar autoinmune (aPAP). Esta nueva prueba solo requiere una muestra de sangre obtenida de un pinchazo en el dedo y ha demostrado 100% de sensibilidad y especificidad analítica en la detección de autoanticuerpos GM-CSF.
Desarrollada en colaboración con el laboratorio certificado por CLIA de TrilliumBiO, la prueba se ofrece sin costo y proporciona una alternativa conveniente a las extracciones de sangre venosa tradicionales. La empresa está finalizando actualmente su presentación BLA rolling para MOLBREEVI™, su potencial primer tratamiento aPAP aprobado por la FDA, que se espera completar para finales del primer trimestre de 2025.
La aPAP es una enfermedad pulmonar rara en la que los anticuerpos neutralizan el GM-CSF, impidiendo la correcta eliminación del surfactante en los pulmones, lo que lleva a dificultades respiratorias y posibles complicaciones graves, incluida la fibrosis pulmonar.
사바라 주식회사 (SVRA)는 미국에서 aPAP ClearPath™ 건조혈액 샘플(DBS) 테스트를 출시하여 자가면역 폐포 단백질증(aPAP) 진단 능력을 향상시켰습니다. 이 새로운 테스트는 손가락을 찔러 얻은 혈액 샘플만 필요하며 GM-CSF 자가항체를 검출하는 데 있어 100%의 분석적 민감도와 특이성을 입증했습니다.
TrilliumBiO의 CLIA 인증 실험실과 협력하여 개발된 이 테스트는 무료로 제공되며 전통적인 정맥 혈액 채취에 대한 편리한 대안을 제공합니다. 회사는 현재 FDA 승인을 목표로 하는 첫 번째 aPAP 치료제인 MOLBREEVI™에 대한 지속적인 BLA 제출을 마무리하고 있으며, 2025년 1분기 말까지 완료할 예정입니다.
aPAP는 항체가 GM-CSF를 중화시켜 폐에서 서 surfactant의 적절한 제거를 방해하여 호흡 곤란 및 폐 섬유증을 포함한 심각한 합병증을 초래하는 희귀 폐 질환입니다.
Savara Inc. (SVRA) a lancé le test aPAP ClearPath™ Dried Blood Spot (DBS) aux États-Unis, améliorant ainsi ses capacités diagnostiques pour la protéinosis alvéolaire auto-immune (aPAP). Ce nouveau test nécessite uniquement un échantillon de sang prélevé par une piqûre au doigt et a démontré une sensibilité et spécificité analytique de 100% dans la détection des auto-anticorps GM-CSF.
Développé en partenariat avec le laboratoire certifié CLIA de TrilliumBiO, le test est proposé gratuitement et constitue une alternative pratique aux prélèvements sanguins veineux traditionnels. L'entreprise finalise actuellement sa soumission BLA en cours pour MOLBREEVI™, son premier traitement aPAP potentiel approuvé par la FDA, prévue pour être achevée d'ici la fin du premier trimestre 2025.
L'aPAP est une maladie pulmonaire rare où des anticorps neutralisent le GM-CSF, empêchant une élimination adéquate du surfactant dans les poumons, ce qui entraîne des difficultés respiratoires et des complications graves potentielles, y compris la fibrose pulmonaire.
Savara Inc. (SVRA) hat den aPAP ClearPath™ Dried Blood Spot (DBS) Test in den USA eingeführt und damit seine diagnostischen Fähigkeiten für die autoimmune pulmonale Alveolarproteinosis (aPAP) verbessert. Dieser neue Test benötigt nur eine Blutprobe aus einem Fingerstich und hat 100% analytische Sensitivität und Spezifität bei der Erkennung von GM-CSF-Autoantikörpern nachgewiesen.
Der Test wurde in Zusammenarbeit mit dem CLIA-zertifizierten Labor von TrilliumBiO entwickelt und wird kostenlos angeboten, was eine bequeme Alternative zu herkömmlichen venösen Blutentnahmen darstellt. Das Unternehmen finalisiert derzeit seine fortlaufende BLA-Einreichung für MOLBREEVI™, ihre potenzielle erste FDA-zugelassene aPAP-Behandlung, die bis Ende des ersten Quartals 2025 abgeschlossen sein soll.
aPAP ist eine seltene Lungenerkrankung, bei der Antikörper GM-CSF neutralisieren, was die ordnungsgemäße Entfernung von Surfactant in den Lungen verhindert und zu Atembeschwerden sowie potenziell schweren Komplikationen, einschließlich Lungenfibrose, führen kann.
- Launch of innovative no-cost diagnostic test with 100% accuracy
- BLA submission for potential first U.S. approved aPAP treatment on track
- Strategic partnership with CLIA-certified lab TrilliumBiO
- MOLBREEVI still pending FDA approval
- Product revenue generation dependent on regulatory approval
Insights
Savara's launch of the aPAP ClearPath Dried Blood Spot (DBS) test represents a strategic diagnostic advancement that complements the company's therapeutic pipeline. This finger-prick blood test for detecting autoimmune pulmonary alveolar proteinosis (aPAP) simplifies the diagnostic process for a rare lung disease that historically faces diagnostic challenges.
The DBS test's 100% analytical sensitivity and specificity in validated cohorts is technically impressive, suggesting high reliability. By partnering with TrilliumBiO's CLIA-certified lab, Savara ensures regulatory compliance while offering the test at no cost to patients—effectively lowering barriers to diagnosis.
This launch creates a compelling diagnostic-therapeutic pairing when viewed alongside Savara's MOLBREEVI (molgramostim inhalation solution), which is approaching the completion of its rolling BLA submission by Q1 2025. The diagnostic test could expand the identifiable patient population for their treatment candidate, potentially widening the commercial opportunity.
From a market perspective, this demonstrates Savara's commitment to building a comprehensive rare disease franchise around aPAP. By addressing both diagnosis and treatment, the company strengthens its position in this niche therapeutic area while potentially accelerating time-to-diagnosis—a critical factor in rare disease management that typically influences treatment outcomes.
The aPAP ClearPath DBS test represents a meaningful diagnostic innovation in the rare pulmonary disease space. The transition from traditional venous blood draws to a simple finger-prick method removes significant logistical barriers for both patients and physicians while maintaining diagnostic integrity.
The test's technical profile is impressive: it demonstrates high correlation between dried serum and traditional serum samples for GM-CSF autoantibody detection while achieving perfect analytical sensitivity and specificity in validation cohorts. This addresses a critical need in the aPAP diagnostic pathway, where patients typically experience delayed diagnoses due to the disease's rarity and symptom overlap with other pulmonary conditions.
What's particularly valuable is the no-cost accessibility of this test, which eliminates financial barriers while maintaining physician involvement in the diagnostic process. This controlled approach balances access with appropriate clinical oversight.
By launching this diagnostic tool ahead of their treatment candidate's potential approval, Savara is effectively priming the market and potentially expanding the identifiable patient population. This creates a virtuous cycle: better diagnostics lead to earlier detection, which improves treatment outcomes and strengthens the case for MOLBREEVI adoption, assuming approval. This strategic sequencing demonstrates sophisticated market development for an ultra-rare condition where patient identification is a significant commercialization challenge.
-- The Simple, No-cost Test Can Detect Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Autoantibodies in the Blood with Only a Finger Prick --
The DBS test demonstrates a high correlation between GM-CSF autoantibody levels in dried serum and traditional serum samples, ensuring reliable results, and has achieved
“I’m pleased to see that Savara has continued to evolve aPAP ClearPath and is now offering a dried blood spot version that provides a convenient alternative to traditional venous blood draws,” said Ali Ataya, M.D., Associate Professor of Medicine, University of
“We are happy to introduce a version of aPAP ClearPath that can provide physicians with a tool to help confirm or rule out aPAP with just a few drops of blood,” said Matt Pauls, Chair and CEO, Savara. “As we near the completion of our rolling BLA submission for MOLBREEVI™ in aPAP, which is on track for the end of 1Q 2025, we are steadfastly committed to our goal of providing the aPAP community with the first and only approved treatment option in the U.S.”
Only a physician or healthcare provider can order the test and make a diagnosis of aPAP. To learn more about aPAP ClearPath, the importance of early testing for aPAP, and to order a test kit, please visit www.apapclearpath.com.
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli (or air sacs) of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication.
TrilliumBiO is a diagnostics company with expertise in novel diagnostic tests developed in conjunction with biopharma partners and other healthcare innovators. Trillium applies clinical insights to help solve the distinct challenges of its partners through scientifically validated, innovative, and customizable products and services, which are physician-approved every step of the way. TrilliumBiO embraces technological advancements and uses state-of-the-art methods to redefine the way they collect, perform, develop, and deliver personalized testing. More information about TrilliumBiO can be found at www.TrilliumBiO.com.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the potential benefits and impact of aPAP ClearPath, including on the time to diagnosis, the occurrence of misdiagnoses, and the diagnosed prevalence of aPAP, statements related to the aPAP ClearPath DBS test helping physicians confirm or rule out aPAP with a small amount of blood, statements related to the anticipated timing of our BLA submission, our goal of providing the aPAP community with the first and only approved treatment option in the
View source version on businesswire.com: https://www.businesswire.com/news/home/20250306574544/en/
Media and Investor Contact:
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Source: Savara Inc.
FAQ
What is the accuracy rate of Savara's new aPAP ClearPath DBS test for SVRA?
When will Savara (SVRA) complete the BLA submission for MOLBREEVI?
How does the new aPAP ClearPath test differ from Savara's previous test?
What are the advantages of Savara's new aPAP ClearPath DBS test?
How can healthcare providers access Savara's aPAP ClearPath test?
