Successful generation of Tc-99m is a supply chain advancement that can help ensure patient access to critical medical imaging scans.
November 9, 2015 – CHALFONT ST. GILES, UK – Technetium-99m (Tc-99m) is used in more than 40 million medical imaging procedures each year, primarily stress tests to assess heart disease, and bone scans to determine the stage of cancer progression. This essential medical isotope is generated in pharmacies and hospitals from another isotope—molybdenum-99 (Mo-99). Despite using half of the world’s supply of Mo-99, the United States does not produce any domestically and imports 100 percent of its supply from foreign nuclear reactors. Many of these reactors are beyond their originally intended lifespans and outages have caused major shortages of Mo-99.
Today, SHINE and GE Healthcare announced they have successfully obtained pharmaceutical-grade Tc-99m from GE Healthcare’s Drytec™ (Technetium Tc99m Generator) For the Production of Sodium Pertechnetate for Tc99m Injection, using Mo-99 produced by SHINE’s innovative process. The positive results of this test confirm that Mo-99 produced by the SHINE process can be incorporated into the existing Mo-99 supply chain. Once approved by FDA, use of SHINE-produced Mo-99 in DRYTEC Tc- 99m generators will not require changes to radiopharmacy practices or how the resulting Tc-99m is used in scanning procedures. SHINE is expected to begin commercial production in 2019 using this new process and expects to be able to produce enough Mo-99 to supply two-thirds of the US patient population.
“We have been confident from the beginning that molybdenum-99 produced by our process would be compatible with existing Tc-99m generators, and now we’ve proved it,” said Greg Piefer, CEO of SHINE. “This demonstration validates that the cleaner, safer technical approach we’ve been pursuing can be fully integrated into the existing supply chain. SHINE greatly appreciates the help of GE Healthcare in proving this essential point. I would like to thank GE and Argonne National Laboratory for making this test possible, as well as our partners at the National Nuclear Security Administration who have provided important support for many of our efforts, including this one.”
After successfully producing technetium-99m (Tc-99m) in the DRYTEC™ Tc-99m Generator using SHINE Mo-99, GE tested it in preparation of finished radiopharmaceuticals using kits of GE Healthcare Tc-99m-based products: Myoview™ (Kit for the Preparation of Tc99m-Tetrofosmin for Injection) and Ceretec™ (Kit for the Preparation of Tc99m Exametazime for Injection). Successful quality control testing was performed on the reconstituted kits, indicating feasibility for Tc-99m radiopharmaceuticals prepared using this material.
GE Healthcare and SHINE signed a long-term, strategic molybdenum-99 supply agreement in 2014. “Our customers—healthcare providers and imaging specialists—rely on a secure supply of molybdenum-99 to ensure that patients can get the diagnostic imaging scans they need,” said Jan Makela, general manager of Core Imaging, GE Healthcare Life Sciences. “We are working hard to make this key isotope readily-available and cost-effective for customers. Successfully using the SHINE material for our DRYTEC™ Tc-99m generator is a promising step in making that goal a reality.”
SHINE’s alternative to highly-enriched uranium (non-HEU) technology also advances the United States’ efforts to eliminate the use of weapons-grade highly enriched uranium (HEU) in Tc-99m production around the world. The SHINE process provides a cost-effective, LEU-based alternative to the HEU-produced Mo-99.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
About SHINE Medical Technologies, Inc.
Founded in 2010, SHINE is a development-stage company working toward becoming a manufacturer of radioisotopes for nuclear medicine. The SHINE system uses a patented proprietary manufacturing process that offers major advantages over existing and proposed production technologies as it does not require a nuclear reactor, uses less electricity, generates less waste and is compatible with the nation’s existing supply chain for moly-99.