Dive Brief:
- Artera has received Food and Drug Administration clearance for an artificial intelligence tool that predicts the likelihood of a certain form of breast cancer developing distant metastases.
- The clearance, which Artera disclosed Wednesday, covers technology that uses histopathology images and clinical variables to stratify patients into low- and high-risk groups.
- Insights into the risk of distant metastases could improve decisions about the use of treatments including chemotherapy, the company said.
Dive Insight:
The clearance covers the use of ArteraAI Breast in early-stage, hormone receptor-positive, HER2-negative invasive breast cancer. Patients are hormone receptor-positive if they have receptors for progesterone or estrogen. In the indicated population, adjuvant endocrine therapy is commonly used to reduce the risk of recurrence, and higher-risk patients may benefit from adjuvant chemotherapy.
Genomic assays such as Exact Sciences’ Oncotype DX Breast Recurrence Score can help determine if the benefits of adjuvant chemotherapy outweigh the risks in an individual. However, some clinical facilities lack access to genomic assays, which researchers studying ArteraAI Breast called expensive and time-consuming to run.
Artera designed its AI tool to provide faster, more cost-effective insights without using biopsy tissue. The company developed the technology using digitized pretreatment biopsy and surgical slides, plus clinical variables including age, tumor size and nodal status. Last year, researchers presented assessments of the effectiveness of the technology at predicting distant metastases and the benefit of chemotherapy.
The company received de novo authorization for a prostate cancer AI tool last year. ArteraAI Prostate uses digital pathology and clinical data to predict long-term outcomes for patients with nonmetastatic prostate cancer. The FDA established a product code category for future AI-powered digital pathology risk-stratification tools as part of the de novo authorization.
Artera is also targeting the European market. The company recently received a CE mark for its prostate and breast cancer tools, positioning it to bring its multicancer AI platform to the European Union. Artera said it is among the first companies to offer such a platform in the EU.
The company launched in 2023 with $90 million in funding from organizations including Johnson & Johnson’s venture capital arm and angel investors such as Salesforce founder Marc Benioff. Artera was already offering the ArteraAI Prostate test as a laboratory-developed test when it officially launched.
