Non-invasive Diagnostics to Improve Gynecologic Health (R43/R44 Clinical Trial Optional)

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The purpose of the Non-invasive Diagnostics in Gynecologic Health RFA is to support SBIR projects to small businesses using advanced technologies (e.g., bio-chips, microfluidics, and mobile technologies) to develop novel or improved diagnostic and/or screening approaches, tools, or devices for endometriosis, adenomyosis, and/or uterine fibroids. The ultimate goal of the program is to improve human gynecologic health by fostering partnerships between small businesses and experts in diverse fields of research to commercialize approaches that improve accuracy and decrease the delay in diagnosis and/or screening of the named gynecologic conditions. These projects will also encourage collaborations with investigators and small businesses who have not yet applied their expertise to gynecologic research, thereby expanding the potential scientific insight and investigational toolkit available to these projects. It is anticipated that, through rigorous collaborative R and D efforts, safe and effective techniques, instruments, and devices can be developed for use in the evaluation and diagnosis of women with endometriosis, uterine fibroids, or adenomyosis. Within the disorders noted above, projects that address a specific and well-characterized clinical need will be considered of high potential impact. The technologies developed with funding through this FOA are expected to be integrated systems or, if they are novel components, to be easily integrated into existing systems. Some other technical features that are expected are the following: reliability, robustness, safety, simplicity, reliance on the appropriate baseline information, contextual awareness, and inclusion of software to support decision-making where appropriate. Proposed tools and technologies should incorporate existing standards and consider regulatory requirements where appropriate. In addition, improved access to underserved areas, and cost-effectiveness should be highlighted.

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