A mutation in the HER2 gene causes aggressive growth in some patients. Credit: Nephron.

Roche has announced the CE-IVD launch of its automated digital pathology algorithms for breast cancer to help to select the best treatment approach for each patient.

Using artificial intelligence (AI), the uPath HER2 (4B5) and uPath Dual ISH image analysis algorithms will enable pathologists in making quick and precise patient diagnoses in breast cancer.

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A mutation in the HER2 gene causes aggressive growth in some patients. Detecting this mutation is necessary for deciding which patients may profit from targeted treatment.

Roche Diagnostics CEO Thomas Schinecker said: “About 15% to 20% of women diagnosed with breast cancer are HER2 positive, which makes fast and accurate diagnosis critical.

“Roche is continuing to innovate in HER2 diagnostics by providing precise information through image analysis algorithms for pathology decision support.”

uPath HER2 (4B5) image analysis for breast cancer helps pathologists to rapidly check if tumours are positive for the HER2 biomarker, highlighting positively stained tumour cell membranes with a clear visual overlay.

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Using uPath HER2 Dual ISH image analysis, pathologists can check for HER2 gene amplification.

Furthermore, a heatmap is provided to guide them to areas of interest where the algorithm can detect cells that will support treatment strategy determination.

Along with the VENTANA DP 200 slide scanner and Roche uPath enterprise software, the latest algorithms deliver novel digital pathology solutions to improve personalised healthcare.

The ready-to-use algorithms are approved for use on the VENTANA HER2 (4B5) assay and the VENTANA HER2 Dual ISH DNA Probe Cocktail and are integrated within the Roche uPath enterprise software.

Last month, Roche launched a high-throughput SARS-CoV-2 antigen test in markets accepting the CE Mark to help to detect Covid-19 infections.