Tempus AI, a leader in artificial intelligence and precision medicine, today announced a new collaboration with United Therapeutics (UT), a leading biotechnology company focused on providing a brighter future for patients through the development of novel pharmaceuticals and technologies. As part of this collaboration, Tempus will develop and investigate AI-based medical device software to detect patients at risk of having undiagnosed pulmonary hypertension (PH).
PH is a fatal, progressive disease of the heart and lungs that affects approximately 1% of the population. Despite an increasing number of available treatments for the disease, the detection or clinical diagnosis of PH is typically delayed for 2 or more years. To help solve this critical problem, Tempus built an algorithm that automatically analyzes the results of a 12-lead electrocardiogram (ECG) to identify patients at risk of undiagnosed PH to be further evaluated by clinicians. The initial findings from this work were recently presented at the American Thoracic Society International Conference in San Diego, California on May 22, 2024.
Tempus’ research and development program will leverage Tempus Next, the company’s AI-enabled care pathway intelligence solution, to facilitate the deployment of the algorithm at participating centers. Clinicians will evaluate its ability to detect patients at risk of undiagnosed PH, and to track clinical outcomes of patients who are identified for further evaluation, within a prospective clinical study at up to 60 centers. Tempus and UT plan to collaborate on this study to investigate the clinical impact of this technology and gain new insights into the detection and diagnosis of PH. Tempus expects to engage with the Food and Drug Administration (FDA) to align on regulatory requirements and FDA expectations regarding validation of this novel AI-based algorithm.
“We aim to set a new standard for identifying patients with pulmonary hypertension by getting novel technology into the hands of clinicians to enable earlier diagnosis and more effective disease management,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. “Exploring this in a prospective multicenter study brings us one step closer to realizing the dream of data-driven precision medicine.”