Lantheus Holdings, Inc., Progenics Pharmaceuticals, Inc., and Exini Diagnostics AB Announces U.S. Food and Drug Administration Clearance for Ai-Enabled Automated Bone Scan Index in Prostate Cancer on GE HealthcareS Xeleris Platform
November 13, 2020 at 08:30 am EST
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Lantheus Holdings, 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. Food and Drug Administration has granted 510(k) clearance for the use of Lantheus' artificial intelligence enabled automated bone scan index product on GE Healthcare's Xeleris platform. 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. 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.
Lantheus Holdings, Inc. is a radiopharmaceutical-focused company. The Company is engaged in delivering science to enable clinicians to find, fight and follow disease to deliver patient outcomes. The Company classifies its products in three categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships. Its Radiopharmaceutical Oncology diagnostics and therapeutic candidates help healthcare professionals (HCPs) find, fight, and follow cancer, with a focus in prostate cancer. Its Precision Diagnostic products assist HCPs to find and follow diseases, with a focus in cardiology. Its Strategic Partnerships focus on enabling precision medicine through the use of biomarkers, digital solutions and pharma solutions platforms. Its commercial products include PYLARIFY, DEFINITY, TechneLite, NEUROLITE, Xenon-133, CARDIOLITE, RELISTOR, Automated Bone Scan Index, and others. Its commercial products are used by cardiologists, internal medicine physicians, and others.
Lantheus Holdings, Inc., Progenics Pharmaceuticals, Inc., and Exini Diagnostics AB Announces U.S. Food and Drug Administration Clearance for Ai-Enabled Automated Bone Scan Index in Prostate Cancer on GE Healthcare’S Xeleris Platform