PS-Detect: A Diagnostic Test for Male Fertility/Infertility

PS-DETECT: A DIAGNOSTIC TEST FOR MALE FERTILITY/INFERTILITY The establishment of PS-Fertility, Inc was motivated by: 1) our recent findings from the laboratory that phosphatidylserine (PS) on the surface of viable sperm is necessary for sperm:egg fusion; 2) that sperm can fuse with myoblast cells in a PS-dependent manner; and 3) the inability of conventional semen analysis assays to provide meaningful information about sperm function. Our overall goal of this SBIR is to refine our simple rapid PS-Detect assay and further develop our business model. This assay will serve to quantify the potential fertilization-competent sperm in an ejaculate. Clinicians view semen analysis as a perfunctory assay, rather than an insightful test to acquire information toward improved assisted reproductive technique strategies. Our market research, performed as part of the NSF I-Corps program, revealed that, overwhelmingly, clinicians would welcome a diagnostic tool that could provide new information about male infertility, specifically sperm health/function. The premise for this application stems our preliminary studies, where we find an unexpected exposure of the lipid phosphatidylserine (PS), which is normally associated with apoptotic cells, on the surface of viable and motile sperm. Further, PS recognition receptors are expressed on the oocytes, and blocking/loss of some of these receptors impairs fertilization. In this Fast-Track SBIR application, we refine our test called PS-Detect that uses PS as a biomarker for fertilization competent human sperm. To our knowledge, there are no semen analysis tests that target our biomarker, nor do any other assays provide information about the potential ability of a sperm to fertilize an egg. In Phase I we will establish a reference range, demonstrate the feasibility of PS-Detect and become a CLIA certified lab. In Phase II we will perform a study on the effects of varicocele on PS Score and build classification models that partition fertile vs sub-fertile samples. Development of this male fertility test `PS-Detect” will provide fertility experts and thus patients with information about male fertility that is currently not available from any other diagnostic. This information will aid in personalizing fertility treatments and reducing emotional and economic costs. Project Number: 1R44HD116616-01A1 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: JEFFREY LYSIAK | Institution: PS-FERTILITY, INC., CHARLOTTESVILLE, VA | Award Amount: $356,502 | Activity Code: R44 | Study Section: Special Emphasis Panel[ZRG1 EMS-K (10)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R44HD11661601A1