046 Rapid Point-of-Care Diagnostics to Detect Serologic Status of Individuals for Select Viral Infections
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will be accepted.
Number of anticipated awards: 1-2
Budget (total costs):
Phase I: $225,000 for up to one year
Phase II: $1,500,000 for up to 3 years.
Congenital infection with cytomegalovirus (CMV) is one of the leading non-genetic causes of birth defects, affecting approximately one in every 150 children born in the U.S., and is a leading cause worldwide of sensoneural hearing loss in babies with or without other symptoms of congenital infection. Neonates infected with herpes simplex virus (HSV) manifest with one of three disease classifications (disseminated disease; central nervous system disease; or skin, eye, and mouth disease) with varying degrees of morbidity and mortality, depending on standards of medical practice across the world. The development of vaccines for CMV and HSV pose significant challenges for vaccine manufacturers. One of these challenges is how to efficiently identify and enroll eligible study subjects in large Phase III efficacy trials. Phase III studies would need to enroll thousands of seronegative subjects, and because the seroprevalence rates for CMV and HSV are high in the target population for vaccination (women of childbearing potential), this will require the screening of tens to hundreds of thousands of potential volunteers. The availability of rapid, accurate and cost-effective POC serodiagnostics would de-risk the development of CMV and HSV vaccines by vastly improving the logistics of enrollment for these large Phase III studies. Specifically, a rapid POC test that could be utilized during initial study screening visits would permit the efficient identification and enrollment of potential vaccinees. In addition, should a vaccine be licensed for seronegative women only, the POC test would permit the efficient implementation of a vaccination strategy in resource-limited countries. For small businesses interested in this topic, reagents such as recombinant CMV and HSV antigens are readily available from the research community to support the development of such a rapid POC serodiagnostic.
The goal of this project is to develop rapid POC diagnostic tests that can determine whether a person has pre-existing antibody to HSV or CMV as an indicator of prior virus infection. The final product should be self-contained, require only a small blood sample (e.g., from a finger stick), provide an immediate (less than 30 minute) readout, and demonstrate the necessary sensitivity and specificity to allow screening of clinical trial subjects/patients for prior virus infection.
Phase I activities can include but are not limited to:
• Development of the prototype POC diagnostic product for detection of HSV or CMV antibodies.
• Determination of the sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the product.
Phase II activities can include but are not limited to:
• Further development of the prototype POC diagnostic product for detection of HSV or CMV antibodies.
• Further determination of the sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the product.
• Final validation testing and scale-up manufacturing of test kits.
This SBIR will not support:
• Nucleic acid-based diagnostics.
• Serodiagnostics that require extensive equipment or time (> 30 minutes) to conduct the assays.
• The design and conduct of clinical trials (see http://www.niaid.nih.gov/researchfunding/glossary/pages/c.aspx#clintrial for the NIH definition of a clinical trial). For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.