PreciseDx

PreciseDx operates at the intersection of artificial intelligence and oncology diagnostics, providing a morphology-driven approach to disease analysis. The company was established in 2019 as a spin-out from the Mount Sinai Health System and was co-founded by Carlos Cordon-Cardo, Gerardo Fernandez, Jack Zeineh, Michael Donovan, and Eric T. Converse. Dr. Cordon-Cardo, a key figure in molecular pathology, envisioned an “inside-out” framework for understanding disease by integrating anatomical pathology with molecular and systems biology, a concept that forms the foundation of PreciseDx. His personal experience as a cancer survivor adds a layer of empathy to the company's mission.

The firm's core business revolves around its proprietary AI platform, the Morphology Feature Array® (MFA), which analyzes standard H&E pathology slide images to provide insights for cancer diagnosis and prognosis. This technology is designed to assist pathologists and oncologists in making more informed treatment decisions. The company generates revenue through its diagnostic testing services offered from its CLIA-certified laboratory. Its clientele includes healthcare providers, pathologists, and oncologists, with collaborations established with institutions like UCLA, COTA, Baptist Health South Florida, and Baylor Scott & White Health.

PreciseDx's flagship product is PreciseBreast™, an AI-powered test for early-stage invasive breast cancer. This test analyzes millions of data points from pathology slide images to generate a Risk of Recurrence Score, independent of HER2 and hormone receptor status. The objective is to provide a faster and more cost-effective risk assessment compared to traditional methods, delivering results in under 48 hours. The technology has received approval from the New York State Department of Health (NYSDOH) under its Clinical Laboratory Evaluation Program (CLEP). Beyond breast cancer, the company's AI platform has demonstrated the ability to detect early signs of Parkinson's disease.

Financially, PreciseDx has secured significant investment to fuel its commercialization and research efforts. The company has raised a total of $43 million, including a Series B funding round that brought in notable investors such as Eventide Asset Management, Labcorp, Quest Diagnostics, Merck Global Health Innovation Fund, and Philips Ventures. These funds are allocated towards ongoing clinical data collection, commercial expansion, and the planned 2026 launch of PreciseBreast™.

Keywords: oncology diagnostics, artificial intelligence, digital pathology, morphology feature array, cancer risk stratification, breast cancer recurrence, PreciseBreast, Carlos Cordon-Cardo, Mount Sinai spin-out, AI-powered diagnostics, pathology analysis, cancer prognosis, clinical decision support, CLIA certified lab, NYSDOH approval, medical diagnostics, healthcare AI, personalized medicine, cancer care, disease analysis