Lantheus Holdings, Inc., the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced the U.S. FDA has granted 510(k) clearance for the use of Lantheus’ artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare’s Xeleris platform.
“Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare’s platform. As a leading multinational medical technology company with deep experience in medical imaging and diagnostics, GE Healthcare presents the ideal attributes to provide global access to this unique digital solution,” said Etienne Montagut, Sr. Vice President of Corporate Development. “aBSI has demonstrated clinical value in quantifying and managing disease progression in advanced prostate cancer patients with the potential to support critical clinical decisions. Lantheus will continue to develop AI solutions to augment and expand the utility of imaging diagnostics for precision medicine in oncology,” Mr. Montagut added.
In October 2019, the Company entered into a global software licensing agreement with GE Healthcare for the rights to aBSI, a vendor neutral stand-alone platform that is enabled with artificial intelligence, which has been trained to automate the detection of hotspots in bone indicative of metastatic disease and calculate the aBSI. The platform offers a fast and reliable alternative to manual interpretation of bone scan images of metastatic prostate cancer. Recent investigations have demonstrated the clinical utility of aBSI as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.1,2
“The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care,” said Erez Levy, General Manager, Nuclear Medicine, GE Healthcare. “For GE Healthcare, that means continuing to advance intelligent and innovative technologies, like aBSI, and deliver precision health to promote better patient outcomes around the world.”
Under the terms of the non-exclusive agreement, GE Healthcare acquired from Lantheus the software license for aBSI for integration into GE Healthcare’s Xeleris platform, excluding the use of aBSI in Japan. Under the agreement with GE Healthcare, Lantheus will receive tiered licensing fees per license sold.
The aBSI product is vendor neutral stand-alone software as a medical device which calculates the automated bone scan index in Technetium-99m bone scintigraphy. aBSI received FDA clearance in 2019 (K191262). The product is enabled with a neural network that has been trained to automate the detection of hotspots and calculate the aBSI value.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden.
About GE Healthcare
GE Healthcare is the $16.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.