Introduction to the Special Series “From Lab to Clinic”

This article is part of our Special Series titled “From Lab to Clinic.” To stay informed about the advancements of a non-invasive diagnostic test for endometriosis through clinical trials and regulatory approvals, follow along with us here.

A Non-Invasive Diagnostic Test for Endometriosis

Researchers at Oxford University have presented preliminary findings from a clinical trial, supported by Serac Healthcare, indicating that a scan-based diagnostic test for endometriosis may soon be available. This innovative test aims to deliver quicker results for women suffering from this painful condition.

The Challenges of Endometriosis

Approximately 10% of women of reproductive age experience endometriosis, characterized by the growth of tissue similar to the uterine lining in the abdominal cavity and pelvis. The origins and development of this condition remain unclear. Common symptoms include intermittent abdominal and pelvic pain, as well as difficulties in conceiving.

Currently, the only definitive method for diagnosing endometriosis at all stages is through laparoscopy, a surgical procedure performed under general anesthesia. Relying on surgery for diagnosis presents significant challenges.

Understanding Endometriosis

Endometriosis occurs when tissue resembling the endometrium grows outside the uterus, forming lesions on various organs, including the intestines and bladder. This tissue responds to sex hormones like estrogen and progesterone, leading to the buildup and shedding of lesions, which causes pain, inflammation, and scarring.

On average, women face a 7.5-year wait for a diagnosis due to a lack of awareness about endometriosis and the complexities involved in diagnosing it. Symptoms often overlap with other conditions, making it difficult for general practitioners to identify endometriosis promptly.

The Diagnostic Dilemma

Due to the necessity of keyhole surgery for accurate diagnosis, patients endure a taxing ordeal involving high costs, surgery risks, and long waiting times. Alarmingly, up to 50% of women referred for laparoscopy may not have visible lesions, leading to unnecessary procedures and recovery without a diagnosis of endometriosis.

Researching endometriosis is equally challenging, as the reliance on surgical methods complicates the ability to study its progression and effects ethically.

Innovative Imaging Solutions

Collaborating with Oxford University, imaging specialists at Serac Healthcare are developing a method to identify potential endometriosis through a body scan similar to a CT scan. This groundbreaking approach utilizes a novel molecular label that highlights tissue mimicking the endometrium, allowing for non-invasive detection of the disease.

How the Imaging Process Works

The team plans to use SPECT/CT scanners to locate endometrium-like patches by employing a specialized molecule that labels newly formed blood vessels. Patients will receive an injection of a radio-labeled imaging agent and undergo scanning, resulting in digital images from which 3D reconstructions will be created. Radiologists will analyze these images for indications of endometriosis.

Maraciclatide: The Key Molecule

The crucial component of this test is Maraciclatide, a labeling molecule that binds to newly formed blood vessels. Initially developed as a cancer detection tool, it has shown promise beyond oncology. Dr. Druin Burch, Chief Scientific Officer of Serac Healthcare, shared insights on the journey of Maraciclatide, which has been repurposed for conditions like rheumatoid arthritis and now endometriosis.

Research and Development Journey

The path to exploring Maraciclatide’s potential for endometriosis imaging was not straightforward. Securing funding for this under-researched condition posed challenges, but the management team succeeded in raising necessary funds for initial research. Growing interest in endometriosis research has fueled enthusiasm among investors to support advancements in this area.

Collaborative Efforts and Clinical Trials

Serac Healthcare’s collaboration with the Oxford Endometriosis CaRe Centre, a leading group in endometriosis research, has accelerated progress. With existing safety data from previous clinical trials, researchers can focus on determining the efficacy of their imaging approach for endometriosis.

Current Research Initiatives

Dr. Tatjana Gibbons and her colleagues presented promising results at the International Society for Reproductive Imaging meeting. The ongoing DETECT study aims to recruit volunteers undergoing laparoscopy to compare the results of the imaging technique with surgical findings. However, establishing imaging parameters for endometriosis remains a significant hurdle before advancing to phase III clinical trials.

Promising Preliminary Results

Dr. Gibbons has reported early findings indicating the ability to detect superficial peritoneal lesions, an early form of endometriosis visible only through laparoscopic surgery. With the trial expected to conclude by year-end, researchers are optimistic about the potential of their non-invasive diagnostic test to significantly reduce the diagnosis delay for endometriosis.

Dr. Burch expressed optimism about the promising early results, emphasizing the potential impact on the diagnostic landscape for endometriosis and the need for a non-invasive testing option.