Multiplexed hormone test for personalizing menopause treatment

The National Institute of Child Health and Human Development awarded Burst Diagnostics Inc. $301,299 on September 15, 2025, under the Child Health and Human Development Extramural Research program (CFDA 93.865) to develop a multiplexed, quantitative point-of-care and at-home diagnostic measuring estradiol, progesterone, luteinizing hormone, and follicle-stimulating hormone in blood and saliva samples. The diagnostic will enable determination of perimenopause and menopause status and personalization of hormone replacement therapy. Work is performed in Colorado and runs through August 31, 2026. Burst Diagnostics is partnering with FemmeLoop on the project. The diagnostic addresses current clinical barriers: existing laboratory testing cycles of 6–12 months are insufficient for effective treatment monitoring, which requires consistent daily to weekly hormone level checks, and current testing costs $80–$150 per test. Existing lateral flow assays and enzyme-linked immunosorbent assays lack the sensitivity and quantitative capability needed to detect the low hormone concentrations present in saliva and blood, particularly estradiol levels as low as 1 picogram per milliliter.

Abstract

Burst diagnostics (burstdx), in partnership with femmeloop, is developing a multiplexed, quantitative point-of- care and at-home diagnostic to measure estradiol (E2), progesterone (PG), luteinizing hormone (LH) and follicle stimulating hormone (FSH). The diagnostic will measure levels in blood and saliva to enable determination of perimenopause/ menopause status and personalization of therapies including but not limited to hormone RE- placement therapy (HRT). Perimenopause/menopause affects 27M women in the USA, impacting 20% of the workforce at a cost of $1.8B. Menopause treatment is growing, with the market for diagnostics and treatment currently at $17B. More frequent hormone level checks could be incredibly beneficial for patients and clinicians. However, the current regime for testing is 6-12 months. Consistent, timed daily to weekly tests are required to establish effective treatment but current laboratory testing cannot meet this demand limited by the high costs of testing ($80-$150). At-home multiplexed hormone detection represents an analytical challenge due to the small molecular size and low hormone concentrations in saliva and blood. E2 levels are as low as 1 PG/ML, progester- one levels as low as 10 PG/ML, LH levels as low as 0.5 MIU/ML, and FSH as low as 0.1 MIU/ML. Lateral flow assays (lfas) and enzyme linked immunosorbent assays (elisas) are commercially available but DON't meet the demand. Lfas are easy to use but lack sensitivity and quantitative abilities. Moreover, hormone measure- ments necessitate the use of competitive immunoassays capable of detecting analyte at PG/ML levels, a feat that is virtually unattainable with lfas. As a result, the market lacks any quantitative lfas specifically designed for monitoring perimenopause/HRT. As a result, there is a clear need for a new at-home multiplexed test that is easy to use, low cost, accurate, and quantitative. Burst diagnostics (burstdx) is developing the capillary-flow driven immunoassay (cadi) as an alternative point-of-care elisa that provides fast, specific, quantitative, multiplexed results. Our goal is to develop a reader that costs