Savara has announced the launch of aPAP ClearPath, a new blood test designed to aid US physicians in diagnosing autoimmune pulmonary alveolar proteinosis (aPAP), a rare autoimmune lung condition.
The serum-based test detects autoantibodies against GM-CSF, which are indicative of the disease.
The aPAP ClearPath test offers a sensitive and specific method for quantifying these autoantibodies in human serum.
Savara chair and CEO Matt Pauls said: “Our commitment to the patient community is underscored by the introduction of this simple, no-cost blood test that US physicians can use to confirm or rule out aPAP.
“With a few thousand diagnosed patients in the US, we suspect the true prevalence of aPAP may be underestimated and, similar to other rare diseases, the introduction of a diagnostic could help decrease the time to diagnosis and increase diagnosed prevalence.”
Developed in collaboration with Trillium Health, a modern health solutions provider and a CLIA-certified laboratory, the aPAP ClearPath test is a simple, cost-free and non-invasive immunoassay.
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Autoimmune PAP is an uncommon lung condition where there is an unusual accumulation of surfactant sediment in the air sacs (alveoli) of the lungs.
It represents about 90% of PAP cases, with an estimated seven diagnosed cases per million in the US. Prevalence rates in other regions are believed to be similar or higher.
Savara has initiated a disease awareness campaign alongside the test to enhance understanding of aPAP, its primary signs and symptoms, and the importance of early testing among healthcare professionals.
Next year, the company plans to launch a healthcare provider disease awareness campaign and introduce a GM-CSF autoantibody blood test in Europe.
University of Florida Pulmonary and Critical Care Medicine division medicine associate professor Dr Ali Ataya said: “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.”