TOPIC 455: DEVELOPMENT OF A RAPID AT-HOME TEST TO DETECT PROSTATE-SPECIFIC ANTIGEN USING SELF-COLLECTED FINGER STICKBLOOD

The goal of this Phase I SBIR project is to develop an at-home rapid test to detect elevated levels of prostatespecific antigen (PSA) in self-collected fingerstick blood samples from persons at risk of prostate cancer. Early detection would especially help African-American men, who have disproportionately high prostate cancer incidence and mortality rates and would benefit from early detection. PSA DetectTM will be a self-contained test kit that detects PSA levels rt10 ng/ml of blood, provides a qualitative result without the use of instruments, and is suitable for self-testing at home. This lateral flow immunoassay will use proprietary InBios detection technologies that are used in FDA approved test kits for infectious diseases. The objectives are to: 1) optimize a PSA test prototype developed by collaborators at Cornell Weill Medical, to meet the assay performance requirements; in parallel, produce a new panel of proprietary test reagents and optimize additional functional test prototypes; 2) perform a prospective study to test three PSA test prototypes in a home-like setting in men rt40 years old, and select a single prototype for future clinical evaluation based on functionality, operability and acceptability; and 3) begin drafting pre-submission documents to seek regulatory guidance for 510(k) clearance for PSA Detect.