Aditxt has signed a market development collaboration agreement with Evofem Biosciences to commercialise the former’s blood-based diagnostic test for endometriosis.
As part of the agreement, the companies will develop a marketing strategy and commercialisation plan for launching Pearsanta’s Mitomic endometriosis test (MET) in the US in mid-2025. Evofem also plans to potentially expand its women’s health portfolio with tests developed by Aditxt’s subsidiary Pearsanta, including a Mitomic ovarian test for early detection of ovarian cancer.
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“We look forward to leveraging our strong relationships with OB/GYNs and allied healthcare providers to plan and execute the successful US launch of this first-in-class non-invasive diagnostic,” said Evofem’s CEO Saundra Pelletier.
Pearsanta’s MET detects a specific deletion in mitochondrial DNA, a novel and proprietary biomarker for endometriosis. The company noted that it has evaluated MET in “over 300 endometriosis cases” and plans to validate the product in 600 cases.
Pearsanta added the MET product to its portfolio earlier this year as part of the $25m acquisition of MDNA Life Sciences. Along with the endometriosis test, the company also added mitomic tests for a variety of cancers including prostate cancer.
Endometriosis occurs when tissue similar to the lining of the uterus (endometrium) grows outside the uterus. It can start at a person’s first menstrual period and last until menopause. There is no known cause of endometriosis and there is no cure for the disease, only symptomatic relief. There are no validated blood tests for diagnosing or screening endometriosis.
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By GlobalDataThe World Health Organization (WHO) estimates that endometriosis affects 10% of reproductive-age women and girls worldwide. GobalData forecasts the endometriosis market to generate $2.91bn across seven main markets in 2030.
The increased awareness of women’s health in recent years has also increased the number of women’s health products, including diagnostics for diseases that were previously hard to detect or required invasive techniques for confirming diagnosis. Earlier this year, Roche received a European CE mark for its Elecsys anti-müllerian hormone (AMH) plus immunoassay as a diagnostic blood test for polycystic ovary syndrome (PCOS), a disease whose diagnosis is often made by the exclusion of other conditions.
