A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NIAID 133

Topic

Development of a Serological Test for Herpes Simplex Types 1 and 2 Infections

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC), are seeking proposals for the development of a serological test for Herpes Simplex Types 1 and 2 infections. The current available serologic tests have high false positive rates, and a more accurate and efficient test is needed. The goal is to create a test that can readily distinguish between HSV-1 and HSV-2 and can be used in clinical settings. The anticipated awards for this solicitation are 1-2, with a budget of $300,000 for Phase I (up to 1 year) and $1,500,000 for Phase II (up to 3 years). The solicitation is closed, and more details can be found on the grants.gov website.

Description

(Direct to Phase II proposals will not be accepted) (Fast-Track proposals will be accepted) Number of anticipated awards: 1-2 Budget (total costs): Phase I: $300,000 for up to 1 year; Phase II: $1,500,000 for up to 3 years Page 118 Background Over 60 million people in the U.S. have genital herpes which is caused by infection with herpes simplex virus type 1 or 2 (HSV-1, HSV-2). The WHO’s 2021 global progress report indicates that more than 500 million people are infected with HSV globally. Currently, genital herpes can be diagnosed based on clinical manifestations of the disease combined with very accurate nucleic acid tests to detect the virus in lesions or on mucosal surfaces. However, many patients with genital herpes are asymptomatic and do not shed virus and therefore a serological test is used to confirm HSV infection. Most available serologic tests, based on the enzyme-linked immunosorbent assay, are efficient but have very high false positive rates with positive predictive values (PPV) of about 50% or lower. Serologic tests for HSV infection using the Western blot have been shown to have high PPV and can readily distinguish HSV-1 and HSV-2. However, the Western blot is not suitable for wide-scale use in clinical settings.