Information sourced from NIH Research Portfolio Online Reporting Tools (RePORT)
Easy-to-use, yet sensitive, diagnostic tests for early detection of invasive aspergillosis (IA) are still-unmet medical need, as IA continues causes morbidity and death in patients with compromised immunity.
In Phase I, Pearl Diagnostics LLC engineered a prototype lateral flow-based device (LFD) called MycoFlow-ASP, and performance was tested using urine samples obtained from patients with suspected and confirmed IA. Results showed >90% sensitivity and specificity, meeting predefined metrics for continued development.
PearlDx received $1.8M from the NIH in the form of an NIAID STTR Phase II grant to complete clinical development and validation of the assay in preparation for an upcoming FDA 510k submission.