AI-enabled Software To Detect Prostate Cancer Bone Metastases Clears FDA

AI-enabled Software To Detect Prostate Cancer Bone Metastases Clears FDA

An artificial intelligence (AI) program that aims to make it easier to identify bone metastases in men with prostate cancer has been granted 501(k) clearance by the U.S. Food and Drug Administration (FDA), its developer announced.

The program uses a neural network — a type of AI — to identify hotspots on bone scans indicative of bone metastasis, which is when cancer cells spread from the prostate and start growing in bone tissue. It also calculates the automated bone scan index or aBSI, an imaging marker that can help detect changes in bone health in men with prostate cancer.

Traditionally, bone scans are assessed manually by a clinician, a process that can be time-consuming and that may be subject to human error. The new program, owned by Lantheus Holdings and also called aBSI, offers a fast and reliable alternative to manual interpretation for detecting hotspots that indicate bone metastases.

Multiple studies have demonstrated the clinical utility of the aBSI index as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.

“aBSI has demonstrated clinical value in quantifying and managing disease progression in advanced prostate cancer patients with the potential to support critical clinical decisions,” Etienne Montagut, senior vice president of corporate development at Lantheus, said in a press release.

The program was approved to run on the Xeleris platform, an imaging platform developed by GE Healthcare. GE and Lantheus entered into a global software licensing agreement for the program in October 2019.

“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,” Montagut said.

Erez Levy, general manager of nuclear medicine at GE Healthcare, said the global COVID-19 outbreak has demonstrated the usefulness of AI and other analytic technology.

“The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care,” Levy said.

“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,” he added.

Under the terms of the 2019 agreement, Lantheus will receive tiered licensing fees from GE per license sold.

The medical imaging development company also recently submitted an application to the FDA seeking approval of PyL, an investigational imaging agent used to locate prostate cancer lesions.

“Lantheus will continue to develop AI solutions to augment and expand the utility of imaging diagnostics for precision medicine in oncology,” Montagut said.