Serac Healthcare, a London-based radiopharmaceutical company, has secured crucial support from the U.S. Food and Drug Administration (FDA) to advance its non-invasive imaging test for diagnosing endometriosis. The test, which uses an innovative imaging agent, could significantly improve the detection of superficial peritoneal endometriosis (SPE), one of the most common yet difficult-to-diagnose forms of the condition.
Endometriosis affects approximately 190 million women globally, causing chronic pain, infertility, and other life-altering symptoms. Currently, a definitive diagnosis requires laparoscopic surgery, an invasive procedure that can delay treatment. Existing non-invasive imaging methods, such as ultrasound and MRI, struggle to detect early-stage or superficial cases of endometriosis.
David Hail, CEO of Serac Healthcare, emphasized the importance of an improved diagnostic approach.
“One in ten women with endometriosis suffer from chronic pain, fertility issues, and depression. A non-invasive test, particularly for early-stage disease which is difficult to visualize by current imaging techniques, is crucial for the 190 million women worldwide dealing with this debilitating condition,” Hail said.
A New Path for Diagnosis: 99mTc-maraciclatide
The key to Serac’s imaging breakthrough lies in its experimental agent, 99mTc-maraciclatide, which targets the angiogenesis process—the formation of new blood vessels that is essential for the growth of endometrial tissue. Previous studies have shown that this process can be imaged effectively using Serac’s agent.
Designed to work with SPECT-CT scans, the agent may offer a non-invasive alternative to surgery for diagnosing endometriosis. Promising results from the early Phase II trials have prompted the FDA to grant Fast Track Designation to 99mTc-maraciclatide in July 2024. This designation aims to expedite the development of treatments for serious health conditions.
The Path Forward
The next critical step for Serac is the Phase III clinical trial, which will compare the imaging results of women undergoing laparoscopy with those of women receiving 99mTc-maraciclatide scans. If successful, the trial could provide a major breakthrough in diagnosing endometriosis, particularly for those with superficial forms of the disease that are difficult to detect through current imaging methods.
Serac Healthcare is preparing to launch the Phase III program, which represents a vital milestone in making this innovative diagnostic tool accessible to patients worldwide, offering a much-needed solution for millions of women who face prolonged misdiagnosis and uncertainty.
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