TOPIC 455: IDEAL AT-HOME PROSTATE SPECIFIC ANTIGEN (PSA) TESTING

Prostate cancer is the seconding leading cause of cancer-related death among men. However, early diagnosis, before the cancer has spread to other regions of the body, can increase patient treatment options and improve survival rates. One successful strategy for enabling early prostate cancer diagnosis is prostate specific antigen (PSA) testing, which measures PSA levels in blood. PSA levels are typically low unless there is a problem with the prostate, which can be an early indicator of prostate cancer. Unfortunately, current PSA tests are costly and require laboratory settings that are prohibitive to broad level screening, i.e., many men at risk for and many men who already have (undiagnosed) early-stage prostate cancer are not having their PSA levels tested and are subsequently missing critical prostate health care. Further, the current diagnostic threshold of these tests overdiagnoses (generates false positive results), which further burdens patients and providers. Thus, new PSA testing technology is needed. During this SBIR Phase I program, technology will be developed to enable point-of-care and at-home testing via a disposable, plug-and-play device that will use an improved qualitive threshold for diagnosis (PSArt10 ng/mL) and the associated qualitative readout to reduce false positives and do so at an affordable/accessible price-point of lt$20 per test. These improvements will better reach underserved and high-risk men. The sooner prostate cancer is detected, the better the prognosis and the more options for effective treatment.