A Point of Care Urine Test to Aid Diagnosis of Aspergillosis

Invasive aspergillosis (IA) was recently named by the WHO as an infection causing “critical” threats to public health, with unmet needs in both diagnostics and therapeutics. Leveraging novel discoveries supporting patent-protected and proprietary technology that enables identification of microbial antigens in urine, Pearl Diagnostics (PearlDx) has developed the first urine assay for IA, formatted as a high-volume enzyme immunoassay (EIA) that is CE marked and under review for clearance at the FDA. PearlDx has also developed a lateral flow device (LFD) that will enable easier, point of care (POC) testing in small hospital labs and clinics. Using support from prior Phase I and II STTR grants, we characterized heterogeneous urinary antigens, and developed methods to combine glycan-specific antibodies and eliminate biologic interferents in urine. Like the EIA, the LFD currently demonstrates 90% sensitivity and specificity, improving on performance of the current blood-based commercial assay and exceeding FDA pre-510k agreed upon metrics for regulatory clearance. To enable use at POC, we now enter the last stage of optimization, which is focused on eliminating the need for a lab to perform sample processing. This commercial readiness pilot proposal supports final integration and clinical testing for FDA clearance of the LFD. Success in meeting the milestones described will lead to commercial availability of the first rapid, easy to use urine diagnostic for IA, enabling earlier detection and therapy of this critical infectious disease threat.