NextGen Jane awarded $2.2 million NIH grant for endometriosis diagnostic

Next step is the final clinical validation of the non-invasive menstrual test for endometriosis in infertility patients

A start-up developing a non-invasive menstrual test for endometriosis in infertility patients has been awarded a new $2.2 million grant to support its final clinical validation.

NextGen Jane received a SBIR Direct to Phase II grant from the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), part of National Institutes of Health (NIH).

Endometriosis is one of the most debilitating and underdiagnosed conditions affecting women's health today. On average, it takes nearly ten years from symptom onset to receive a diagnosis; this delay has serious implications for fertility. The current standard of surgical confirmation of disease contributes to the endometriosis diagnostic odysessy.

A non-invasive alternative to surgery

NextGen Jane is tackling this problem with a non-invasive alternative: using tampon-collected samples to capture and decode the molecular signals shed from the uterine lining. The approach builds on the company’s broader platform, which combines next-generation sequencing with longitudinal sample collection to better understand the biological activity of the uterus over time.

The company’s endometriosis assay draws on both human and microbial biomarkers, offering insight into the transcriptional activity of the uterus and the microbiome in people with endometriosis and infertility. This dual analysis could help uncover patterns currently missed by conventional diagnostic methods.

"We are delighted to receive this continued financial support and validation from NICHD, which will accelerate our mission to bring precision diagnostics to people with gynecologic conditions that are often overlooked," said Ridhi Tariyal, Co-Founder and CEO of NextGen Jane.

"Endometriosis diagnosis and treatment in the context of infertility can be especially frustrating, as long delays, expensive appointments, and few alternatives for care can lead to patient distress, disease sequelae and increased time to conceive. The at-home collection system will help patients understand whether they have a chronic, inflammatory condition as they navigate the complex terrain of fertility treatment."

This marks the second NIH award for the company to further their research on endometriosis ($1.8M in 2020 through the Fast Track mechanism). The new award is a significant milestone for the company as it continues to expand its platform for capturing and decoding uterine health through the menstrual cycle. The work also sets the stage for broader applications of menstrual effluence analysis in areas like fertility, infection, and gynecologic cancer detection.