Non-Invasive Blood Test for Endometriosis Could Replace Surgical Procedures

Endometriosis affects 6.5 million women in the United States and remains notoriously difficult to diagnose, with patients waiting an average of seven years for a definitive diagnosis. The current diagnostic standard—laparoscopic surgery—is invasive, expensive, and carries inherent risks and side effects. This delay in diagnosis often forces women to endure severe pelvic pain, painful intercourse, fatigue, and infertility without proper treatment. Many patients are told their symptoms are normal, even when they are experiencing disabling pain. The lack of a simple, non-invasive diagnostic method has led to misdiagnosis or no diagnosis at all for countless women. Now, a new blood-based test offers a quicker, safer, and more accessible pathway to diagnosing endometriosis, potentially transforming patient care.

The EndomTest, developed by Kephera Diagnostics (Framingham, MA, USA), measures two specific biomarkers, Brain Derived Neurotrophic Factor (BDNF) and Cancer Antigen 125 (CA125), in human serum and combines them with clinical variables using a proprietary algorithm to provide a rule-in diagnostic result. Both BDNF and CA125 have been shown in studies to be elevated in the serum of patients with endometriosis versus healthy controls. While each individual biomarker is not 100% specific to endometriosis, the combined measurements of the levels of both biomarkers together with selected patient history information was found to yield a highly specific assay for endometriosis, suitable as a “rule in” test. The test requires only a blood sample, offering a non-surgical diagnostic option for patients.

Image: The test combines an immunoassay on a patient’s blood sample with clinical information in a diagnostic algorithm (Photo courtesy of Kephera Diagnostics)

With the EndomTest, clinicians now have a non-invasive blood test for endometriosis that offers an attractive alternative to laparoscopy—an invasive procedure with risks common to surgeries, including the potential for post-surgical complications. Published clinical validation studies demonstrate that EndomTest delivers 100% specificity, meaning no false positives were reported in the methodology used. The specificity of the test means that a positive result provides a patient with certainty about their condition. This high accuracy can inform critical treatment decisions, including whether surgery is necessary, and support earlier treatment options for patients. The test is expected to fill critical gaps in women's healthcare by providing a reliable and accessible alternative to surgical diagnosis for endometriosis.

“We are proud to be launching the first non-invasive test for endometriosis in the United States. EndomTest leverages Kephera’s scientific expertise in in-vitro assays for challenging diseases. With the launch of this test through our CLIA lab, we hope to provide a diagnostic solution that will improve healthcare for thousands of patients who are affected by endometriosis,” said Andrew Levin, Chief Executive and Scientific Officer, Kephera Diagnostics.

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