Pearl Diagnostics I Products to Prevent Infection|

STTR Award Phase 2

//STTR Award Phase 2

STTR Award Phase 2

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, Inc. 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.

By | 2018-03-05T13:59:49+00:00 July 1st, 2017|