Savara, a clinical-stage biopharmaceutical company dedicated to rare respiratory diseases, has significantly advanced the diagnostic landscape for autoimmune pulmonary alveolar proteinosis (aPAP)—a rare autoimmune lung disease characterized by the abnormal buildup of surfactant due to autoantibodies neutralizing GM-CSF—with the U.S. launch of its aPAP ClearPath Dried Blood Spot (DBS) Test, an evolution from its earlier serum-based assay, which now enables a diagnostic assessment using only a convenient finger-prick blood sample. This innovative, simple, no-cost, and noninvasive test, developed and validated through a partnership with TrilliumBiO's CLIA-certified lab, demonstrates a high correlation between GM-CSF autoantibody levels in dried serum and traditional serum samples, ensuring reliable results with confirmed 100% analytical sensitivity and specificity in a cohort of individuals with known GM-CSF autoantibody status, thereby reducing logistical barriers for both patients and healthcare providers and potentially facilitating earlier and more accurate diagnoses to avoid common, lengthy misdiagnoses often associated with aPAP.

The new DBS version of the test has been praised by medical professionals for its convenience and reliability. The company's leadership has underscored its steadfast commitment to the aPAP community, highlighting the test's utility in helping to confirm or rule out aPAP with just a few drops of blood. This development comes as the company nears the completion of its rolling BLA submission for MOLBREEVI™, a recombinant human GM-CSF currently in Phase 3 development for aPAP, delivered via an investigational eFlow® Nebulizer System, and anticipated to be on track for the end of Q1 2025. The ultimate goal is to provide the first and only approved treatment option for aPAP in the U.S. Autoimmune PAP itself originates from GM-CSF neutralization by antibodies, which impairs the crucial function of alveolar macrophages in clearing surfactant. This impairment leads to compromised gas exchange and clinical symptoms such as shortness of breath, cough, and fatigue. Over time, the disease can result in serious long-term complications, including lung fibrosis or the need for a lung transplant, particularly if secondary lung infection develops.

Importantly, only a physician or healthcare provider can order the aPAP ClearPath test and render a diagnosis. Savara continues to leverage its management team's extensive experience in rare respiratory diseases to address unmet medical needs.