Microgen LLC — Department of Health and Human Services SBIR Phase I: CDC

Description

Project Summary In response to NOT-EB-21-001 (Small Business Initiatives for Innovative Diagnostic Technology for Improving Outcomes for Maternal Health), we propose to develop a high-throughput, user-friendly diagnostic test for Treponema pallidum (T. pallidum) and Herpes simplex virus (HSV types 1 and 2) at the point-of-care (POC). Microgen’s POC test is likely to reduce costs and turn-around times as testing is performed at a single location for both pathogens. Genital and anogenital ulcers can be caused by infection with T. pallidum, but in many cases they are caused by an HSV infection. T. pallidum is the causative agent of syphilis, a sexually transmitted infection that can cause serious health problems if it is not treated. Syphilis in pregnant women can cause miscarriage, stillbirth, or the baby’s death shortly after birth. Infections with HSV-1 or HSV-2 are highly prevalent worldwide and both types commonly cause genital infection; primary and reactivation of HSV increases the risk of transmission to the fetus or neonate. Neonatal HSV infection can have devastating long- term consequences, especially when the central nervous system is involved. Thus, there is an urgent need for a nucleic acid amplification test (NAAT) to detect HSV and T. pallidum that could be used to identify at-risk pregnant women at the point-of-care. Microgen’s One-Step platform is an innovative, low-cost, and user- friendly technology that can address this challenge. The goal of this project is to develop an inexpensive ($20 each) and rapid (15-25 min from sample to result) NAAT to detect both T. pallidum and HSV, allowing immediate counseling and treatment. Development of this test will provide a new tool for diagnosis, particulary in pregnant women. PUBLIC HEALTH RELEVANCE: Infection with either HSV or T. pallidum during pregnancy can have devastating consequences for the mother and infant. HSV commonly causes genital lesions and there is risk of transmission to the fetus or neonate. Notably, HSV infections in neonates have a high mortality rate. Both diseases can be treated effectively with medication but is highly dependent on rapid diagnosis. Despite their strong disease association and similar clinical presentation, there is no rapid, inexpensive POC diagnostic test that detects both pathogens. The goal of this project is to develop a high-throughput assay for the simultaneous detection of both HSV and T. pallidum. By reducing the severity of disease via faster diagnosis, the health and well-being of mothers and babies will be significantly improved.