NextGen Jane, a women's health company developing menstrual diagnostics, has secured a $2.2 million SBIR Direct to Phase II grant from the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), part of the National Institutes of Health. The funding will support final clinical validation of the company's non-invasive menstrual test for endometriosis in patients experiencing infertility.
The grant provides $759,944 in the first year and represents the second NIH award for NextGen Jane, which previously received a $1.8 million Fast Track grant in 2020 for endometriosis research.
"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.
Addressing a Critical Diagnostic Gap
Endometriosis affects millions of women worldwide and currently faces significant diagnostic challenges. The condition takes an average of nearly ten years from symptom onset to diagnosis, with the current diagnostic standard requiring surgical confirmation. This lengthy process has serious implications for patients' fertility and quality of life.
Tariyal emphasized the particular challenges in fertility contexts: "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."
Innovative Diagnostic Approach
NextGen Jane's technology offers a non-invasive alternative to surgical diagnosis. The company's approach uses tampon-collected samples to capture and analyze molecular signals shed from the uterine lining. This method allows for the detection of both human and microbial biomarkers, providing comprehensive insight into uterine transcriptional activity and microbiome characteristics specific to patients with endometriosis and infertility.
The at-home collection system aims to help patients understand whether they have this chronic, inflammatory condition while navigating fertility treatment options. This approach could significantly reduce the time to diagnosis, allowing for earlier intervention and potentially improved fertility outcomes.
Broader Applications in Women's Health
Beyond endometriosis, NextGen Jane's platform establishes a foundation for broader applications of menstrual effluence analysis. The technology shows promise for additional diagnostic applications in areas such as fertility assessment, infection detection, and gynecologic cancer screening.
The continued NIH funding represents significant validation for NextGen Jane's scientific approach and underscores the critical need for improved diagnostic tools in women's health. The company's work addresses a substantial unmet need in gynecological care, particularly for conditions like endometriosis that have historically been underdiagnosed and undertreated.
Clinical Validation Process
The new grant will specifically support the final stages of clinical validation for the endometriosis diagnostic test. This validation process is crucial for demonstrating the test's accuracy, reliability, and clinical utility before it can be widely implemented in healthcare settings.
If successful, NextGen Jane's diagnostic could transform the standard of care for endometriosis, potentially reducing the years of suffering many patients endure before receiving an accurate diagnosis and appropriate treatment. The company's work represents an important step toward more accessible, non-invasive diagnostics in women's health.
