With great fanfare, the Mayo Clinic won FDA approval late last year for a new diagnostic imaging agent that helps determine when prostate cancer has returned. But as Bloomberg reports, the non-profit medical center has struggled to expand access to the compound.
C11 Choline is a radioactive imaging agent designed for PET scan use, and it highlights tiny cell changes that can flag the early development of new prostate cancer tumors. Once spotted, a biopsy confirms the diagnosis and can propel early and aggressive intervention. And advocates believe it can reduce the need for other diagnostic tests prostate cancer patients typically require. It's also a first for the Mayo Clinic, as it is the first product it has ever shepherded entirely through FDA regulatory approval. And as the article notes, the Mayo Clinic gave up exclusivity to encourage its production and wider use by other organizations.
But here's the thing. Due to production requirements, the compound has to be administered a few minutes after it's produced. Blame the radioisotopes, which deplete to half their effectiveness in about 20 minutes, according to the story. For now, that reality has limited the imaging agent's use to the Mayo Clinic itself, where demand for the imaging agent/PET scan has been soaring.
The Bloomberg story points out, however, that FDA regulations have limited broader commercialization of the imaging agent, requiring separate FDA approval processes even if rival medical centers use the Mayo Clinic's exact same FDA-approved formula.
The FDA, meanwhile, defends its regulations of imaging agents as a necessary means to make sure they remain safe as a diagnostic treatment tool.
- read the Bloomberg story