The Centers for Disease Control and Prevention (CDC), the Office of Science (OS) in late December 2022 issued a Broad Agency Announcement (BAA) for the competitive selection of research proposals, including a Request for Proposal (RFP) for a new serologic test for herpes simplex virus (HSV).
Therefore, the goal of the RFP is to develop, validate, and make accessible confirmatory (2nd step) HSV serologic assays for diagnosis, especially for HSV-2, to improve the specificity of the testing algorithm. Offering such testing widely will increase equitable access for all persons in need of confirmatory testing.
Because of poor performance of commercially available FDA-approved tests, and limited availability of confirmatory (2nd step) testing, prevention efforts for transmission of herpes have been insufficient. Herpes spreads without public health intervention primarily by asymptomatic carriers, emphasizing the critical and unmet need for accurate diagnosis and testing. With this announcement, the CDC indicates their support for accurate testing and diagnosis, and further advances the prevention of HSV transmission as a national priority.
Learn more about advocacy for herpes cure, treatment and prevention here.
Sexual health advocates have long called on the CDC, FDA and federal agencies to address the silent epidemic of herpes by urgently prioritizing cure, treatment and prevention. Providers and patients have been asked to report the poorly performing tests to the FDA. There are 572,000 confirmed cases of genital herpes a year in the US, according to a 2018 report. Prevalence of oral herpes is unknown but estimated to be 50% of Americans.
Project objectives include:
- CDC seeks projects to develop type-specific serologic assays for confirmation of HSV diagnosis, especially for HSV-2, that improves the specificity of the serology testing algorithm overall.
- Develop technology and user interface for specimen submission with high accessibility to various healthcare providers and linkage to commercial submitter laboratories for processing and reporting.