Serac Healthcare secures FDA backing for next stage endometriosis diagnosis imaging trial
Trial offers new hope for endometriosis diagnosis
A British healthcare company has received positive feedback from US regulators for a new non-invasive imaging test that could transform the diagnosis of endometriosis.
Serac Healthcare, a London-based radiopharmaceutical firm, has announced that the US Food and Drug Administration (FDA) has endorsed its plans for a Phase III clinical trial of an innovative imaging agent for diagnosing one of the most common and undiagnosed forms of endometriosis, known as superficial peritoneal endometriosis (SPE).
Endometriosis affects an estimated 190 million women worldwide, causing chronic pain, infertility, and a significant impact on quality of life. Currently, definitive diagnosis requires laparoscopic surgery. This is an invasive procedure that can delay treatment. Existing non-invasive imaging techniques, such as ultrasound and MRI, struggle to detect early-stage or superficial forms of the disease.
David Hail, Chief Executive of Serac Healthcare, said:
“Chronic pain, fertility issues and depression are just some of the consequences that one in ten women with endometriosis are living with every day.
“A non-invasive test, particularly for early-stage disease which cannot easily be visualised by other imaging methods, and which accounts for eighty per cent of diagnoses by laparoscopic surgery, is desperately needed by the 190 million women worldwide suffering from this debilitating condition.”
Identifying endometriosis without surgery
The growth of endometrial tissue is dependent upon new blood vessel formation (angiogenesis) which studies have shown can be imaged with Serac’s experimental agent, known as 99mTc-maraciclatide.
99mTc-maraciclatide is designed to work with SPECT-CT scans, potentially offering a breakthrough in identifying endometriosis without the need for surgery.
Early Phase II trial results have been promising, leading the FDA to grant the agent Fast Track Designation in July 2024, a status aimed at accelerating the development of treatments for serious conditions.
The upcoming Phase III trial will compare the imaging results of women undergoing laparoscopy with scans taken using 99mTc-maraciclatide. If successful, the test could provide an urgently needed alternative for millions of women who face years of uncertainty and misdiagnosis.
The company is now preparing to launch its Phase III programme, a critical step toward making the test available to patients worldwide.