From the June 2019 issue of DOTmed HealthCare Business News magazine
By Leah Gannon
Last year’s announced shutdown of two international research nuclear reactors, utilized to create the products necessary for SPECT imaging, again revealed the weakness of the radiopharmaceutical supply chain. The American market relies on these reactors to produce a radioisotope called molybdenum-99 (Mo-99), which is then is eluted in nuclear pharmacies to make its daughter isotope, technetium-99 (TC-99).
TC-99 is the main radioactive material used in 80 percent of nuclear imaging tests, including SPECT (single photon emission computed tomography). When maintenance or unexpected reactor issues disrupt the delivery of this product, the effect is felt immediately.
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Shaking confidence even more, The New York Times reported last year that nervous pilots had refused to fly with the radioactive materials onboard. The lack of essential, raw radioactive materials to prepare radiopharmaceutical doses hinders the ability of providers to perform unique diagnostic functions and therapeutic treatment of cardiovascular, neurologic and oncologic disease, which puts patients at risk.
While the ongoing supply chain fragility of Mo-99 is cause for concern, there is reason to be cautiously optimistic about the longer term availability of these “low energy” radioactive materials. New domestic sources are emerging that will increase the ability to acquire radioactive isotopes. Additionally, there is a lot of market buzz about the expansion of positron emissions tomography (PET) imaging, which utilizes “high energy” radioactive materials.
US suppliers to join the Mo-99 market
In 2018, the National Nuclear Security Administration (NNSA) issued a funding opportunity announcement for the production of Mo-99. Four U.S. companies received funding awards in the first quarter of 2019 from the NNSA to further the efforts toward establishing a reliable domestic supply of nuclear isotopes. These efforts also support continued progress to reestablish the domestic production for non-HEU (highly-enriched uranium) Mo-99, which had been unavailable since 1998.
The four companies receiving NNSA funding are:
• NorthStar Medical Radioisotopes, located in Beloit, Wisconsin
• SHINE Medical Technologies, located in Janesville, Wisconsin Northwest
• Medical Isotopes, located in Corvallis, Oregon
• Niowave, located in Lansing, Michigan
And that’s just the beginning. The NNSA is reaching out to six other companies with potential funding opportunities as well. That’s potentially 10 new players supplying the U.S. market, meaning less reliance on foreign medical reactors to produce the medical isotope. How quickly this comes to fruition is yet to be seen, but the outcome should inspire the trust of clinicians and patients.