4D Path Prepping FDA Submission for AI-Enabled Breast Cancer Digital Pathology Product


Although many pathologists still use traditional microscopic methods to interpret the clinical qualities of cancerous tumor tissue, digital pathology has seen increasing uptake in laboratories in recent years as more products become available and receive regulatory approval.

Digital pathology firms that harness artificial intelligence (AI), such as Paige and Proscia, have raised millions in private financing over the past year, and Inspirata has partnered with companies such as DeePathology to provide artificial intelligence-based digital pathology solutions.

Boston-based 4D Path is another company offering a digital pathology workflow that uses the power of AI to provide clinical diagnosis of tumor tissue and predictive indices that can help group patients for the correct therapy, according to 4D Path’s Founder and Chief Scientist Satabhisa Mukhopadhyay.

The firm’s cloud-based algorithm can extract microenvironmental dynamics, or “cell-to-cell talking,” from images and translate that information into molecular immune profiles. That information includes the basics of histopathology, including the tumor’s grade, but also includes molecular information, such as hormone receptor status, Mukhopadhyay said.

4D Path’s first product, the 4D Q-plasia OncoReader Breast, received Breakthrough Device Designation from the US Food and Drug Administration last year and has been patented in the US. Breast cancer is the first focus, but far from the only – the company’s Founder and CTO Tathagata Dasgupta said that it will expand into lung, ovarian, and skin cancer next.