A recent article about the opening of PETNET's first molecular imaging biomarker production facility in Chennai, India, caught my attention for a couple of reasons (see: Siemens to launch PETNET services in India). Below is an excerpt from the article with boldface emphasis mine:
Siemens...announced the launch of its project to set up [PETNET's] first molecular imaging biomarker production facility in Chennai. The new facility will enable the healthcare providers in and around Chennai to access the PET.CT technology for diagnosis of patients with life-threatening diseases ...PETNET Solutions, a fully owned subsidiary of Siemens Medical solutions, operates the largest PET radiopharmacy network [comprised of] over 44 radiopharmacies and distribution centers at multiple locations that produce and distribute PET radiopharmaceuticals to hospitals, clinics, and research facility for PET imaging....The new facility will house the Siemens Eclipse HP cyclotron which will be deployed to manufacture FDG (fluorodeoxyglucose), the imaging biomarker used in PET.CT facilities to assist with the diagnosis and staging of disease processes and to monitor cellular response to treatments such as chemotherapy and radiotherapy. Currently, there is no PET.CT in Tamilnadu because of non availability the vital imaging biomarker FDG, which is essential to do the imaging in PET.CT. FDG has a half-life of only 110 minutes (losing half of its activity every 110 minutes) and hence needs to be produced locally.
The first point of interest for me in this article relates to the term imaging biomarker. In a previous note (see: Use of Term Biomarker vs. Analyte), I used the following definition of biomarker: any molecular species found to provide correlation to a particular phenotype or perturbation of a biological system. I must confess to my preconceived notion that a biomarker was a substance that was quantified in serum or tissue. The use of the term to apply to an imaging radiopharmaceutical caught me by surprise. Nevertheless, its use in this way is certainly within the scope of the definition that I cited, particularly when modified by the term imaging.
The second point of interest relates to Siemens' status as a major manufacturer of PET/CT imaging systems. For the use of this medical imaging technology to flourish, the company needs to ensure a ready supply of FDG to its customers, the most important radioisotope used in for PET imaging. As noted above, the substance has a half-life of only 110 minutes and thus needs to be produced in close proximity to the imaging device itself. I can't articulate the PETNET business model more clearly than the company's itself on its web site:
PETNET Solutions has carefully planned and successfully built the SafetyNet, a unique program by which your delivery of PET tracers is guaranteed on time through our national network of cyclotron-based radiopharmacies.On time and reliable delivery of high quality PET biomarkers is essential for the successful operation of a PET practice.
An interesting analogy can be drawn between the IVD companies that manufacture both the analyzers and the "juice" (i.e., reagents) that are required for the analyzers to work and PET/CT. In this latter case, Siemens produces both the hardware and the "juice" (i.e., FDG). However, the "juice plant" need to be close to the hospitals that have installed the imaging devices. Most IVD reagents are relatively stable and can manufactured and then shipped anywhere in the world.
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