Current Status of Positron Emission Tomography
PET scanning is the fastest growing medical imaging modality in the U.S. Its primary role has been in oncology, where it has an expanding role in diagnosis, the monitoring of therapy or the progression of disease, and in the staging of patients for radiation therapy. Most oncology PET procedures are now adequately reimbursed under Medicare and by insurance companies. Research has demonstrated the effectiveness of diagnostic applications in cardiology and neurology, including the early diagnosis of Alzheimer's disease, and reimbursement as clinical procedure is expected soon.
Expansion of the PET market from its clinical beginnings in the early 1990s has been rapid, but it has been limited by the availability of the radiopharmaceutical necessary for imaging. Because the physical half life of [18F]FDG is short (110 minutes) and because it must be produced using a particle accelerator (e.g., cyclotron), each PET scanner must be in close proximity to a commercial PET radiopharmaceutical manufacturing facility that costs $2 $4 million to construct. For this reason, clinical PET is generally available only in large cities where a radiopharmaceutical manufacturing facility can serve a minimum of four or five PET scanners. In medium and smaller sized cities, the radiopharmaceutical must be shipped from the manufacturer at a very high cost, and, owing to the short life, impaired reliability. Commercial PET radiopharmaceutical manufacture, and to some extent PET scanning itself, has not generally been a viable business in a geographical area with an accessible population less than 500,000. Mobile scanners serving smaller cities a few days per week have helped extend PET scanning to these markets, but the problems with radiopharmaceutical supply remain.
As PET procedures increase in volume, and as competition for the patient increases, reimbursement will surely decrease. This, and the already felt price erosion because of sales competition in PET radiopharmaceuticals among the many manufacturers, produces a widening gap between PET-capable and PET-incapable cities. The answer to this dilemma is obvious; shared, locally owned PET radiopharmaceutical manufacturing centers that produce quality product for a limited market.
The problems with the formation of a cost effective small volume producer have been:
- Finding PET scanner operators who are willing to cooperate in constructing a shared radiopharmaceutical manufacturing center.
- Locating capital required for the investment.
- Providing the expertise in:
- Accelerator radiation safety
- Accelerator physics
- Quality control
- Drug regulatory affairs
- Providing manufacturing management.
There are not enough adequately trained and experienced people available to staff a significant number of these sites.
Cyclomedical Applications Group offers the solution to these problems.