Technology Transfer Licensing Opportunity: Diagnostic Kit to Detect Human Infertility

Opportunity: The U.S. Environmental Protection Agency’s (EPA) Federal Technology Transfer Act team solicits inquiries from companies seeking to develop government-developed, government-owned intellectual property through licensing arrangements. Specifically, EPA is offering the opportunity to enter into a license agreement to further commercialize, manufacture, and market the following technology. The license agreement(s) granted may be exclusive or non-exclusive in nature and may include exclusivity based on specific fields of use. EPA provides no funding to licensees through its license agreement contracts. This is not a procurement.

Technology Context: Currently, the only agreed upon infertility indicator in human males is a complete lack of sperm motility. Sperm count, a secondary infertility indicator, lacks a threshold value universally agreed upon by the medical community. In fact, laboratories and clinicians disagree on the number of sperm per milliliter required for a man to be considered fertile or infertile. Since as many as twenty percent of men may be categorized as infertile, a better indicator of male fertility status is needed.

Technology Summary: Derived from the Park 7 gene, the Sperm Membrane Protein 22 (SP22) is highly correlated with fertility in Sprague Dawley rats and has also been observed in human fertility expression. EPA inventor Gary Klinefelter claims a kit where SP22 can be detected in a motile semen sample using one of seven sequence IDs listed in U.S. Patent 8,497,135.

Recent research in Klinefelter’s laboratory built on the patented technology and identified the human gene sequence correlating with human male fertility and the ability to lead to a live birth. Klinefelter’s laboratory further built on the technology to create a custom antibody synthesized for use in the patented kit. The improved kit presents an opportunity for more reliable male fertility testing when used to identify human gene sequence expression of SP22.

To learn more, reference: Klinefelter, G. R., Diamond, M. P., & Krawetz, S. A. (2024). Immunolocalization of SP22 (Park7) on the human sperm membrane is indicative of live birth. Reproduction and Fertility, 6(1). https://doi.org/10.1530/raf-24-0074.

Potential Technology Applications: Human Fertility Testing Human Fertility Research Comparative Biology Research Technology Development Status:

Current Technology Readiness Level (TRL): 3/4 Patent protection exists for this technology. Reference U.S. Patent 8,497,135, “Diagnostic kits to detect SP22 and SP22 antibodies” to learn more.

License Agreement Process Information: Please visit https://www.epa.gov/ftta for more information on working with EPA’s Federal Technology Transfer Act team and on this technology. To express interest in this opportunity, please submit a license application form to EPA’s Federal Technology Transfer Act team. Information concerning the license application process and editable license application templates are available at https://www.epa.gov/ftta/epa-licensing-information.

If you have any questions, please e-mail EPA’s Federal Technology Transfer Act team at ftta@epa.gov with the title of this Technology Transfer Licensing Opportunity as listed in this SAM.gov notice and your preferred contact information. For more information about licensing other EPA-developed technologies, please visit https://www.epa.gov/ftta/epa-technologies-available-licensing.

Contact Information Contracting Office Address:

Washington, DC 20460, USA Primary Point of Contact: EPA’s Federal Technology Transfer Act team, ftta@epa.gov