INSILIXA, INC. — Department of Health and Human Services SBIR Phase I: NIDCR

Description

DESCRIPTION provided by applicant Human Papilloma Virus HPV oral infection is responsible for an increasing percent of head and neck cancers The risk of progression from infection to cancer is increased by persistent HPV infection infection with high risk HPV types high viral load and increased abundance of HPV E E transcripts and host p INK A transcripts Rapid cost effective point of care POC tests that detect and quantify risk associated biomarkers in oral biospecimens are needed for oral cancer screening prognostic purposes and to follow up persons treated for high grade lesions Hypothesis We hypothesis that it is possible to use the InSilixa HYDRA K CMOS biochip to develop a multiplex assay that can detect identify and quantify HPV high and low risk types in oral tissues and fluids Preliminary Data Co investigators at UNC have developed a non POC multiplex qPCR assay that can detect identify and quantify HPV and L gene type specific sequences and HPV E gene consensus sequences common to all HPV types This assay has been used in clinical studies of oral biosamples InSilixa engineers have developed the sensor pixel multiplex HYDRA K CMOS biochip and used this platform to identify separate SNPs in the M tuberculosis genome that confer drug resistance Specific Aims The proposed Phase I project seeks to develop a complementary metal oxide semiconductor CMOS platform the InSilixa HYDRA K as a POC molecular diagnostic device that can detect type and quantify HPV DNA in oral biospecimens In Specific Aim we will design fabricate test and optimize HPV type specific and generic capture probes attached to a dynamic microarray experimental setup and proxy for the InSilixa HYDRA K biochip In Specific Aim we will design fabricate test and optimize primers for an asymmetric quantitative multiplex PCR assay that amplifies regions of the HPV genome that contain HPV type specific and consensus sequences In Specific Aim we will determine the performance specifications of a HPV dynamic microarray assay that integrates the capture probes from Specific Aim with the asymmetric quantitative multiplex PCR assay from Specific Aim Successful completion of these Specific Aims will provide the basis for a Phase II SBIR application that will migrate the HPV assay developed here from the dynamic microarray setup to the HYDRA K CMOS platform PUBLIC HEALTH RELEVANCE This project will develop a rapid and inexpensive diagnostic test that can be used in a doctor or dentist office or clinic for the early detection of cancer causing viruses in the mouth and throat