World’s First Molecular, Cell-Based Test Offers Non-Surgical Method for Diagnosis and Staging of Endometriosis

Endometriosis is a very painful disorder in which tissue similar to that which normally lines the uterus migrates and grows on other organs outside of the uterus. The disease affects about 10-20% of women across the world and is responsible for a high majority of female infertility cases. Awareness of a patient’s endometriosis status and stage can save significant amounts of money spent on misdiagnosis and interventions that could be unsuitable for the stage of the disease. Additionally, during infertility, treatment of the underlying endometriosis before intervention can increase the chances of success by modifying the interventions after taking into account the underlying disease. Now, researchers will soon begin a clinical trial evaluating the world’s first molecular, cell-based test for diagnosing and staging endometriosis without surgery.

Hera Biotech (San Antonio, TX, USA) is developing and commercializing the world’s first non-surgical test for the definitive diagnosis and staging of endometriosis. Hera’s breakthrough approach is based on cutting edge, single cell, micro-fluidic analysis to identify endometriosis-specific biological markers. This approach enables clinicians to definitively diagnose endometriosis regardless of stage with unparalleled accuracy. A sample of the patient’s endometrium is collected using a uterine brush biopsy during an in-office procedure, thereby eliminating the need for surgery. MetriDx configuration utilizes micro-fluidic analysis of single cells obtained from the patient to definitively diagnose and stage endometriosis.

MetriDx can provide physicians with unprecedented diagnostic capability, reduce the liability risk for hospitals, eliminate unnecessary surgical procedures, and minimize the amount of time for patients before they receive a diagnosis, all the while maintaining tissue collection and a direct pathology diagnosis. MetriDx will initially be offered to both OB/GYN practices and those in the fertility solutions market as a laboratory developed test (LDT). MetriDx can also be utilized as a screening test in OB/GYN practices, in fertility clinics and by reproductive endocrinologist practices. The first patient for the proof-of-concept multi-center clinical trial of the MetriDx endometriosis diagnostic test has already been enrolled.

“Women in the US endure eight years and ten plus doctor’s visits, on average, before they get a diagnosis,” said CEO and Co-Founder Somer Baburek. “I want the process for obtaining a definitive answer about your endometriosis status to be as easy and as routine as getting a pap smear.”

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