Development of an annual test to inform women about their future fertility

This solicitation, issued by ARPA-H under the Department of Health and Human Services, seeks the development of an affordable, annual diagnostic test to identify new biomarkers that inform women about their future fertility. The goal is to provide actionable data and an estimated timeline for the onset of infertility, enabling better childbearing decisions and enhancing natural fertility options before IVF becomes necessary. This Phase I SBIR effort is a total small business set-aside under NAICS code 325413, with a response deadline of September 30, 2027. The program is structured in phases, with Phase I lasting up to 24 months and Phase II or Sequential Phase II lasting up to 36 months, with a possible 6-month extension. Awardees may request additional Technical and Business Assistance funding of up to 6,500 dollars for Phase I and 50,000 dollars for Phase II. Proposals are evaluated based on technical merit, novelty, team expertise, and the path to market impact. Applicants must submit a solution summary, key personnel worksheet, and a cost proposal, and may be required to deliver an oral technical presentation accompanied by a Gantt chart and task description document. All deliverables must comply with Revised 508 accessibility standards, and payment requests must be processed electronically through the Department of Treasury Invoice Processing Platform.