Cernostics

About Cernostics

Cernostics, founded in 2008 by Dr. Rebecca Critchley-Thorne and Michel Nederlof, operates as a diagnostics company specializing in spatial biology and AI-driven image analysis for cancer prognostics. Dr. Critchley-Thorne, who served as the Chief Scientific Officer, leveraged her background in cancer immunotherapy and highly multiplexed biomarker analysis from her doctoral work and postdoctoral fellowship at Stanford University to pioneer the company's core technology. Cernostics was established as a spin-off from Cellumen's personalized medicine unit. The company's significant milestone was its acquisition by Castle Biosciences in a deal valued at up to $80 million, which was completed in December 2021. Following the acquisition, Cernostics became a wholly-owned subsidiary, with its Pittsburgh-based laboratory and management team, including then-CEO Mike Hoerres, transitioning to Castle.

The company's business model centers on providing precision diagnostic testing services to clinicians, specifically gastroenterologists. Revenue is generated through its proprietary laboratory developed tests (LDTs). The primary market for Cernostics is the gastrointestinal diagnostics space, addressing a segment with an estimated total addressable market of $1 billion. The company's main offering is the TissueCypher® Barrett's Esophagus Assay, the first precision medicine test designed to predict the future development of esophageal cancer in patients with Barrett's Esophagus (BE), a precursor to the highly lethal cancer. This condition affects approximately 4 million patients in the U.S., with around 400,000 endoscopies performed annually on this patient population.

The TissueCypher® platform is the core technology, which distinguishes itself from traditional, subjective pathology by applying AI and spatial biology to analyze tissue biopsies. It uses multiplexed fluorescence on whole slide digital images to quantify multiple biomarkers related to the tumor, immune system, and stroma simultaneously, while preserving the tissue's structural context. This patented approach provides an objective, individualized risk score for patients with non-dysplastic, indefinite, or low-grade dysplasia BE. The benefit for clinicians is the ability to make more informed management decisions, identifying high-risk patients who may require earlier intervention and low-risk patients who can avoid unnecessary procedures, ultimately aiming to reduce the incidence of esophageal adenocarcinoma.