PEARL DIAGNOSTICS, INC. — Department of Health and Human Services STTR Phase II: NIAID

Description

Invasive aspergillosisIAcontinues to cause morbidity and death in medically immune compromised patientslargely because we lack sensitive diagnostic tests that are easy to use during high risk periodsWe discovered that fungal galactofuranose containing antigens are excreted in urine of infected animals and peopleusing a novel monoclonal antibodymAbIn a phase I STTRwe engineered a lateral flow deviceLFDcalled AspUTestand performance was tested using urine samples obtained from patients with suspected and confirmed IAResults showed rtsensitivity and specificitymeeting predefined metrics for continued developmentThis Phase II application is designed to meet the following Specific AimsTo optimize production of the AspUTest deviceTo determine performance characteristics of AspUTest as an aid to diagnose invasive aspergillosis using batched samples obtained from patients with hematological malignanciesandTo validate and test the performance of AspUTest in clinical microbiology laboratoriesMeeting these aims will enable submission for FDA clearance of AspUTestmarking an important advance towards decreasing IA morbidity with expanded availability of a low costeasy to use urine diagnostic