The United States Food and Drug Administration (FDA) has granted a Fast Track Designation to imaging agent 99 mTc-maraciclatide for use in endometriosis diagnosis. A non-invasive test for endometriosis with reliable and consistent performance could transform women’s healthcare. This technology, developed by Serac healthcare, will not only allow fast assessment of the condition, it will also open the door for researchers trying to understand endometriosis and how to treat it.
In a press release David Hail, Chief Executive Officer of Serac Healthcare, said:
‘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. We are committed to working closely with the FDA and clinicians to complete the development of 99 mTc-maraciclatide. A non-invasive test which could be used for earlier diagnosis of endometriosis would represent a major advance in women’s healthcare.’
Fast Track
The FDA Fast Track process speeds up the journey from the lab to the clinic. It will allow FDA administrators to prioritize applications concerning 99 mTc-maraciclatide for use in imaging of superficial endometriosis. In practice this means that the FDA will hold more frequent meetings with Serac Healthcare to get the process moving and 99 mTc-maraciclatide could be eligible for accelerated approval and priority review.
While this does not confer instant approval for the new imaging agent, it does signal a vote of confidence for the imaging protocols demonstrated in the DETECT clinical trial. The FDA only grants Fast Track Designation to drugs and medical devices that will provide a substantial enhancement of patient experience compared to current available treatments. This could mean filling an unmet need, offering an alternative treatment with fewer risks and side effects or significantly improving on present methods.
A New Strategy
Until now the definitive diagnostic tool for endometriosis has been laparoscopic surgery. Serac Healthcare has developed an imaging technique that can detect superficial endometriosis. This test avoids the need for surgery while giving answers that a biomarker blood test simply aren’t equipped to give. Radiologists would give the patient a dose of 99 mTc-maraciclatide imaging agent, then perform a simple SPEC/CT scan. As we reported earlier this year, preliminary results of phase II clinical trials have been encouraging, with researchers hoping to complete the trial by the end of 2024.
Endometriosis is a chronic condition affecting at least ten percent of females of reproductive age worldwide. Women and girls suffering from the disease experience chronic pain amongst other concerning symptoms. It’s unclear how the condition starts or how it progresses, but it manifests as clumps of endometrium-like tissue growing outside the uterus.
