Serac's SPECT-CT agent gets regulatory approval

Serac Healthcare has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its diagnostic SPECT-CT agent maraciclatide technetium-99m to diagnose superficial peritoneal endometriosis (SPE) in women ages 16 years and older.

SPE is the earliest and most common form of endometriosis, comprising approximately 80% of all cases. However, due to the plaque-like nature and generally small size of lesions, the condition is not well visualized with current noninvasive imaging tools and definitive diagnosis requires laparoscopy.

Preliminary data from the "Detecting Endometriosis expressed integrins using technetium-99m (DETECT)" imaging study showed that maraciclatide technetium-99m correctly identified SPE in women who went on to have this early-stage endometriosis confirmed by laparoscopy. The ongoing phase-II study will be completed later in 2024, Serac said.

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