NIH Small Biz Grant Supports Uterine Health Diagnostic

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23 Feb. 2022. A women’s health diagnostics developer is receiving funds for a non-invasive test analyzing menstrual fluids to detect the uterine disorder endometriosis. National Institute of Child Health and Development or NICHD, part of National Institutes of Health, is awarding $1.5 million to NextGen Jane in Oakland, California to confirm and refine genomic indicators in menstrual fluid for the test.

Endometriosis occurs when tissue resembling the lining of the uterus grows outside the uterus. According to WomensHealth.gov, endometriosis affects 11 percent of women in the U.S. between the age of 15 and 44. The disorder, says the agency, occurs more often among women in their 30s and 40s, making it difficult to become pregnant. Other symptoms are menstrual cramps and other pain, bleeding between menstrual periods, and digestive problems. Pelvic exams, ultrasound, or MRI imaging can help detect endometriosis, but laparoscopic surgery is needed to confirm the diagnosis.

NextGen Jane says that despite laparoscopic surgery, endometriosis reoccurs in half of women with the condition. Moreover, says the company, the time between onset of the disease and diagnosis averages 10 years. As a result, says NextGen Jane, there’s an unmet need for a safe, quick, and easy-to-use diagnostic test for endometriosis.

The company is developing what it calls a smart tampon system to collect and test menstrual fluids, to provide a yes or no answer to women who think they may have endometriosis. The at-home device, as envisioned by NextGen Jane, will collect menstrual fluids for rapid measurement of blood volume and biomarker analysis to return a yes/no signal for the disorder.

Develop big-data analytic tools

Earlier, NextGen Jane received a grant of nearly $268,000 from NICHD to verify the feasibility of detecting multiple RNA biomarkers in menstrual fluids with a smart tampon device. The new award provides funds over two years to confirm the preliminary analysis of RNA biomarkers in menstrual fluid, with a sample of 72 women diagnosed either with or without endometriosis. The grant also supports gathering RNA sequencing and other data from some 300 women before and after undergoing laparoscopic surgery for endometriosis, to validate true-positive sensitivity and true-negative specificity of those biomarkers.

“To overcome a significant barrier in helping women with endometriosis,” says NextGen Jane co-founder and CEO Ridhi Tariyal in a company statement released through BusinessWire, it is critical to increase disease awareness through convenient at-home testing.” Tariyal adds, “This competitive NIH grant helps NextGen Jane take the next steps in developing the big-data analytic tools needed to establish the molecular signature of this novel non-invasive diagnostic for patients in obstetrics and gynecological care and for women who want greater control of their own health.”

NextGen Jane is also participating in a study with Baylor College of Medicine in Houston to identify genomic signatures for endometriosis onset and remission. The study is part of a project to identify inflammatory pathways that could lead to precision medicine treatments for endometriosis harnessing the body’s own mechanisms against the disorder.

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials.

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