99mTc-maraciclatide Granted FDA Fast Track Designation for the Diagnosis of Superficial Peritoneal Endometriosis

 London, UK, 2 July 2024. Serac Healthcare Limited, a clinical radiopharmaceutical company developing an innovative molecular imaging agent, announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation to ^99mTc-maraciclatide as a diagnostic SPECT-CT agent for the visualisation and diagnosis of superficial peritoneal endometriosis in women of 16 years and 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. Criteria include improving the diagnosis of a serious condition where early diagnosis results in an improved outcome.