PHOENIX BIOSYSTEM, INC. — Department of Health and Human Services SBIR Phase I: N

Description

DESCRIPTION provided by applicant Trachoma is a blinding disease caused by Chlamydia trachomatis CT Mass drug treatment with azithromycin MDA is part of the WHO endorsed andapos SAFEandapos strategy for trachoma control in endemic communities However to accurately assess the feasibility of eliminating trachoma it is essential to have a diagnostic test that can correcty measure the true status of ocular CT infection in individuals In designing the optimal regimen for antibiotic treatment it is important to know if re emergent infection represents treatment failure reinfection from untreated members of the community or reinfection from sources outside the community The most widely used test for monitoring trachoma is conjunctival examination using the WHO simplified grading system It has been shown that the positive predictive values for these tests are far lower than those of the NAAT based assays This indicates that basing treatment decisions solely on the simplified grading system will result in treatment of a considerable number of uninfected persons The commercial NAAT assays presently available are too expensive too complex or too unreliable for use in national programs There is an urgent need for a rapid cost effective reliable NAAT test for C trachomatis to assist in measuring progress towards the elimination of trachoma We propose to develop rapid accurate sensitive and cost effective NAAT based POC system to fulfill the unmet market needs in resource limited settings RLS The system can be readily expanded to include other tests for use in RLS including HIV Viral load Syphilis MGen HPV and HCV PUBLIC HEALTH RELEVANCE Trachoma is a blinding disease caused by ocular infection with CT Trachoma continues to be the target of a global effort by the WHO to eliminate the disease as a public health concern by the year Our proposed product will result in a field deployable device for diagnosis ocular CT and the system can be readily expanded to include other assays