NIH Phase I SBIR grant will support development of a low-cost, multiplexed, at-home hormone test to transform menopause care.
Fort Collins, CO and Los Angeles, CA – October 30, 2025 – Burst Diagnostics (BurstDX), in a joint venture with FemmeLoop, has announced the award of a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). This award will accelerate the development of a low-cost, at-home hormone test and integrated digital health platform to deliver personalized insights into perimenopause and menopause.
Phase I will advance a multiplexed urine-based assay and accompanying smartphone-connected reader capable of quantitatively measuring estradiol, progesterone, follicle-stimulating hormone, and luteinizing hormone. This collaboration seeks to address a critical gap in menopause care by replacing infrequent clinic testing with an at-home system that establishes hormone baselines and tracks fluctuations over time, giving patients and providers the continuous data needed to inform individualized treatment.
The project leverages BurstDX’s Capillary Driven Immunoassay (CaDI™) platform that condenses a traditional enzyme-linked immunosorbent assay (ELISA) into a cartridge-based format capable of delivering quantitative results in under ten minutes. In combination with FemmeLoop’s digital platform, which integrates biomarker data with symptom tracking, the system aims to provide women with a comprehensive tool to improve menopause management.
BurstDX and FemmeLoop will conduct this research in collaboration with Dr. Nanette Santoro of the University of Colorado School of Medicine, a nationally recognized expert in reproductive endocrinology and menopause research. “A well-validated way to measure hormonal fluctuations can be a valuable self-monitoring tool to help women make sense of their menopause symptom experience,” said Dr. Santoro. The platform will be validated through a clinical concordance study using deidentified, banked clinical samples from the Santoro lab to demonstrate agreement with gold-standard ELISA results and confirm the platform’s readiness for real-world use.
“BurstDX is excited to provide an important tool to help women going through the menopause journey by providing valuable data on their hormone cycles,” said Dr. Charles Henry, CEO and Co-Founder of Burst Diagnostics. “Our goal is to enable women to navigate this time while maintaining their quality of life.”
“FemmeLoop believes, to truly care for women through menopause, we must listen not only to their stories but also to their biology,” said Felicia Sandoval-Spraggon, CEO and Founder of FemmeLoop. “Through our joint-venture with BurstDX, we are excited to incorporate biological data that will allow women to see the full picture — the rhythms, changes, and signals of the body — so we can understand, support, and empower them through this profound transition.”
This work is supported by the National Institutes of Health under award number 1R43HD116666-01A1. For more information, please visit www.burst-dx.com and www.femmeloop.com/
About Burst Diagnostics Burst Diagnostics is an early-stage diagnostics company
translating laboratory-grade immunoassays into rapid, cost-effective formats
for use in point-of-need settings. Its proprietary Capillary Driven Immunoassay
(CaDI) platform delivers ten-minute quantitative results through an easy-to-use
format, supporting both Burst-branded products and custom assay solutions. The
platform enables detection across a broad range of targets and sample types in
clinical and non-clinical applications, including food safety, veterinary
diagnostics, wellness, environmental monitoring, and beyond.
About FemmeLoop FemmeLoop is an integrated platform designed to redefine menopause
with powerful prediction, planning, and health insights to give women control, clarity,
and tools to live longer, stronger, and on their terms during the midlife
transition and beyond.
Media
Contacts: Josi Shearer,
Burst Diagnostics jshearer@burst-dx.com Felicia “Fee”
Sandoval-Spraggon, CEO and Founder, FemmeLoop fee@femmeloop.com
