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The designation allows the company to use its digital pathology system, also called Optrascan, as an in vitro diagnostic tool in the EU.
Oxford University Hospitals NHS Foundation Trust will use the Philips Intellisite system to create a digital pathology network across a number of UK hospitals.
The UK government aims to create six centers specializing in digital pathology, medical imaging or both, working together through a framework agreement.
Digital pathology has been relegated to research use only in many smaller labs, but an FDA approval last year, and more options targeted to them, may change that.
The firm's algorithm rapidly identifies skin irregularities by comparing the image to data from its cloud-based database, acting as a diagnostic aid for pathologists.
The firm recently announced a $3.15 million grant from the NIH, and it supported work that resulted in the first-ever digital primary diagnosis of a suspected cancer case.
Its CEO said the firm wants to make its tissue classifier the clinical standard for stratifying patients at risk of getting esophageal cancer.
Illumina Ventures was the sole investor in the Series A1 round, which will go toward Cernostics' clinical and market development studies for its TissueCypher Barrett's Esophagus assay.
The five-year award will go toward developing a tool that will be based on digitized hematoxylin and eosin (H&E)-stained pathology images alone.
The approval follows a validation study that included 3,300 cases and 6,600 FFPE glass slides at four sites in India.