Pearl Diagnostics, Inc.

Mycomeia - Urine Diagnostic for Aspergillosis - Aspergillosis Causes Morbidity and Death in Medically Immune Compromised Patients, Especially After Cancer Chemotherapy and Transplant. Recently, We Have Witnessed Increased Cases of Influenza-associated Aspergillosis and COVID-19-ASSOCIATED Aspergillosis, Complicating Effective Treatment in Those Critically Ill With Viral Infections. Outcomes Are Poor in Part Because We Lack Sensitive Diagnostic Tests That Are Easy to Use During High-risk Periods. During Our Efforts to Develop Easier Diagnostic Tests, We Discovered That Fungal Galactofuranose (galf)– Containing Antigens Are Excreted in Urine of Infected Animals and People, Using Novel Monoclonal Antibodies. We Engineered a Prototype Enzyme Immunoassay Called Mycomeia, and Performance Was Tested Using Urine Samples Obtained From Patients With Suspected and Confirmed Ia. Results Showed >80% Sensitivity and Specificity, Meeting Predefined Metrics for Clinical Study. as Part of This Proposal, This Design-locked Assay Will Move Into Clinical Study, in Three Clinical Microbiology Laboratories to Support Fda 510K Application. Additional Work Is Proposed to Understand How the Urine Assay Can Be Optimized to Detect Aspergillosis in Non-hematology Patients at Risk, Including Icu Patients With COVID-19. Success in Meeting the Milestones Described Will Lead to Commercial Availability of the First Rapid, Easy to Use Urine Diagnostic Assay for This Important Fungal Infection, With Potential to Reduce Disease Prevalence and Improve Outcomes.