Savara Inc., a clinical stage biopharmaceutical company focused on rare respiratory diseases, recently launched aPAP ClearPath, a new serum-based blood test that can be used by physicians to obtain a definitive diagnosis of autoimmune pulmonary alveolar proteinosis (aPAP), a rare autoimmune lung disease mediated by autoantibodies targeting GM-CSF. 

Autoimmune PAP accounts for approximately 90% of all patients with PAP and has an estimated diagnosed prevalence of seven cases per million in the U.S. and similar or higher prevalence reported elsewhere in the world, the company says.

The aPAP ClearPath test is a highly sensitive and specific quantitative immunoassay designed to detect aPAP GM-CSF autoantibodies in human serum, according to Savara. The company partnered with Trillium Health, a modern health solutions provider and a Clinical Laboratory Improvement Amendments (CLIA)-certified lab, to develop the simple, no-cost, and noninvasive test. A supporting disease awareness campaign was also launched to improve understanding of aPAP, highlight the hallmark signs and symptoms of the disease, and educate physicians about the need for early testing.

Further reading: Mayo Clinic Labs and Progentec Collaborate on Advanced Biomarker Tests for Autoimmune Diseases

“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,” says 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., 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.”

Only a physician or healthcare provider can make a diagnosis of aPAP. 

“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,” says Ali Ataya, MD, associate professor of Medicine, University of Florida, Division of Pulmonary and Critical Care Medicine. “I congratulate Savara for making this simple test broadly available for physicians in the U.S.”

The company expects to roll out a healthcare provider disease awareness campaign and GM-CSF autoantibody blood test in Europe next year.

Graphic: Savara