This fast track designation for maraciclatide highlights the FDA's recognition of the critical need for improved diagnosis of endometriosis. Congratulations to the Serac Healthcare team for putting together this successful application which will help to accelerate the development of maraciclatide in this important indication.
We are excited to report major news this week for the development of ⁹⁹ᵐTc-maraciclatide as an imaging agent for endometriosis: the US Food & Drug Administration (FDA) has granted fast track designation to maraciclatide "for the visualisation and diagnosis of superficial peritoneal endometriosis in women 16 years of age or older". Fast track is a process designed to facilitate the development and expedite the review of drugs to treat (or in our case, diagnose) serious conditions and fill an unmet medical need so that patients can benefit sooner. Superficial peritoneal endometriosis (SPE) is the earliest and most common form of endometriosis, comprising approximately 80% of all diagnoses. SPE is not well visualised with current non-invasive imaging tools (ultrasound and MRI) and definitive diagnosis requires laparoscopy. In data previously reported from the DETECT study being run by our colleagues at the Nuffield Dept of Women's & Reproductive Health, University of Oxford, maraciclatide correctly identified superficial peritoneal endometriosis in those who went on to have this early-stage endometriosis confirmed by laparoscopy. Please see full details here: https://lnkd.in/eQM3nCKm Maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities. #FDAFastTrack #endometriosis #womenshealth #molecularimaging #diagnosticimaging #medicalimaging #precisionmedicine #nuclearmedicine EndoCaRe Oxford 🎗️ Spectrum Dynamics Medical Hermes Medical Solutions Krina Zondervan Tatjana Gibbons