Artera gets FDA okay for prostate cancer AI
Micrograph of prostate cancer.
Artificial intelligence specialist Artera has won FDA approval for AI-powered software that can help guide the management of patients diagnosed with localised prostate cancer.
ArteraAI Prostate is billed by its developer as "the first and only AI-powered software […] to prognosticate long-term outcomes for patients with non-metastatic prostate cancer." The multimodal artificial intelligence (MMAI) uses an algorithm that can analyse digital images from a patient's biopsy and clinical data to predict, for example, whether they will benefit from hormone therapy.
The algorithm was developed using data from thousands of patients and tens of thousands of pathology slide images, and has been clinically validated in multiple phase 3 trials, including new data from the STAMPEDE study reported at this year's ASCO congress.
STAMPEDE was a landmark study that showed adding abiraterone to standard treatment for non-metastatic prostate cancer improved survival, although the drug does come with side effects and requires additional monitoring for potential issues with high blood pressure or liver abnormalities.
Using Astera's AI to analyse images collected in the study from more than 1,000 men, it was revealed that the software could distinguish between those most likely to benefit from abiraterone and those who would do well from standard treatment with hormone therapy and radiotherapy.
New product category unlocked
The approval of ArteraAI Prostate by the FDA as a software as a medical device (SaMD) means it can now be used at the point of diagnosis at qualified pathology labs in the US, and also establishes a new product code category for future AI-powered digital pathology risk-stratification tools, according to the company.
"This is a defining moment for AI in cancer care," said Andre Esteva, chief executive and co-founder of Artera, which previously won a breakthrough device designation from the FDA for the tool.
"The FDA's decision validates the power of our MMAI platform to deliver on our vision to create AI-guided tools that enable data-backed and tailored treatments for each patient, leading to more confidence throughout the cancer journey, and ultimately save more lives," he added.
Digital pathology tools can help reduce the workload of pathologists, particularly in areas where access to pathology services is stretched, and are also being used to support drug development in the biopharma industry.
"As the demand for pathology services continues to outpace available capacity, tools like ArteraAI Prostate are critical," commented Dr Adam Cole, founder and chief scientific officer of digital-focused pathology organisation TruCore.
"Implementing this software enhances our ability to deliver personalised insights more quickly, improves workflow efficiency, and allows us to scale services while increasing the quality of care."
