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Development of a High Throughput Assay for Rapid Detection of HSV and Treponema pallidum

Award Information
Agency: Department of Health and Human Services
Branch: Centers for Disease Control and Prevention
Contract: R43PS005273-01
Agency Tracking Number: R43PS005273
Amount: $299,801.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: CDC
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2024-09-29
Small Business Information
903 Texas Avenue
LA MARQUE, TX 77568-3318
United States
DUNS: 111389362
HUBZone Owned: Yes
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (409) 935-6700
Business Contact
Phone: (409) 935-6700
Research Institution

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.

* Information listed above is at the time of submission. *

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