LANGHORN, PA — Savara Inc. (Nasdaq: SVRA) announced the recent launch of aPAP ClearPath™, a revolutionary serum-based blood test designed to provide definitive diagnoses of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease. This disease is caused by autoantibodies that target Granulocyte-macrophage colony-stimulating factor (GM-CSF), and accounts for approximately 90% of all PAP cases.
The aPAP ClearPath™ test represents a significant breakthrough in the detection of GM-CSF autoantibodies in human serum. This highly sensitive and specific quantitative immunoassay was developed in partnership with Trillium Health, a modern health solutions provider and a Clinical Laboratory Improvement Amendments (CLIA)-certified lab.
Alongside the launch of the test, Savara also initiated a disease awareness campaign aimed at improving understanding of aPAP, highlighting its key signs and symptoms, and educating physicians about the importance of early testing.
“Our strong operational focus continues as we deliver on our goal of introducing a laboratory-based GM-CSF autoantibody blood test in the U.S. by the end of the year,” said Matt Pauls, Chair and CEO, Savara. “Our commitment to the patient community is underscored by the introduction of this simple, no-cost blood test that U.S. physicians can use to confirm or rule out aPAP.”
With a few thousand diagnosed patients in the U.S., it’s suspected that the true prevalence of aPAP may be underestimated. Similar to other rare diseases, the introduction of a diagnostic could help decrease the time to diagnosis and increase diagnosed prevalence.
“Education and widespread blood testing for aPAP is a critical step in shortening the time to diagnosis for patients with aPAP, helping to avoid misdiagnoses and more costly and invasive diagnostic procedures,” said Ali Ataya, M.D., Associate Professor of Medicine, University of Florida, Division of Pulmonary and Critical Care Medicine.
The test can only be ordered by a physician or healthcare provider. Savara plans to roll out a healthcare provider disease awareness campaign and GM-CSF autoantibody blood test in Europe next year.
Savara’s introduction of aPAP ClearPath™ holds significant potential for the diagnosis and treatment of aPAP, offering a non-invasive, cost-effective solution that could transform the landscape of this rare lung disease. The company’s continued commitment to patient care and innovative solutions positions it as a leading player in the biopharmaceutical industry.
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