Emerging SPECT/CT Agent Gets FDA Fast Track Designation for Superficial Peritoneal Endometriosis

The Food and Drug Administration (FDA) has granted a fast track designation for the SPECT/CT radiotracer ^99mTc-maraciclatide in the detection of superficial peritoneal endometriosis, which comprises approximately 80 percent of diagnosed endometriosis, a condition that affects 190 million women and adolescents of reproductive age.^1,2

Offering a high binding affinity to the cell adhesion protein αvβ3 integrin, ^99mTc-maraciclatide enables imaging of angiogenesis, which plays a key role in the development of endometriotic lesions, according to Serac Healthcare, the developer of ^99mTc-maraciclatide.

The SPECT/CT radiotracer ^99mTc-maraciclatide recently demonstrated promising findings in the detection of superficial peritoneal endometriosis in preliminary research presented at the 7th European Endometriosis Congress in Romania. The imaging agent recently garnered a fast track designation from the Food and Drug Administration (FDA). (Images courtesy of Serac Healthcare.)

Conventional imaging such as ultrasound and magnetic resonance imaging (MRI) reportedly have limitations in detecting the small lesions and plaque-like appearance of superficial peritoneal endometriosis. However, preliminary research from the ongoing phase II DETECT trial, presented at the 7th European Endometriosis Congress last month in Romania, demonstrated that ^99mTc-maraciclatide accurately diagnosed superficial peritoneal endometriosis in patients who had subsequent confirmation of the condition via laparoscopy.³

“Granting fast track designation to maraciclatide highlights the FDA's recognition of the critical need for improved diagnosis of endometriosis. The average delay for diagnosis of this condition, which affects 190 million women worldwide, is seven and a half years and is often only possible with laparoscopy,” noted David Hall, the chief executive officer of Serac Healthcare.

In discussing the aforementioned preliminary study findings with ^99mTc-maraciclatide, Krina Zondervan, M.D., said the SPECT/CT agent may represent a key advance in facilitating earlier diagnosis of endometriosis.

“A non-invasive diagnostic option for superficial peritoneal endometriosis could be transformative in enabling young women to make different life choices and avoid years of pain. … Maraciclatide has a real possibility of helping us to meet this goal,” posited Dr. Zondervan, head of the Nuffield Department of Women’s Reproductive Health at the University of Oxford in the United Kingdom.³

References

1. Serac Healthcare. 99mTc-maraciclatide granted FDA fast track designation for the diagnosis of superficial peritoneal endometriosis. Available at: https://www.serachealthcare.com/news-cpt/%e2%81%b9%e2%81%b9%e1%b5%90tc-maraciclatide-granted-fda-fast-track-designation-for-the-diagnosis-of-superficial-peritoneal-endometriosis/ . Published July 2, 2024. Accessed July 2, 2024.

2. Endometriosis. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/endometriosis . Published March 24, 2023. Accessed July 2, 2024.

3. Serac Healthcare. Continuing positive results for imaging of endometriosis with 99mTc-maraciclatide. Available at: https://www.seraclifesciences.com/wp-content/uploads/2024/06/6_7_24-DETECT-PR-EEC-FINAL.pdf . Published June 7, 2024. Accessed July 2, 2024.