US FDA Clears Estrogen Receptor Image Analysis and Digital Read Application for Breast Cancer

Ventana Medical Systems, Inc. (Tucson, AZ, USA), a member of the Roche Group, has now received 510(k) clearance from the US Food and Drug Administration (FDA) for its Companion Algorithm ER (SP1)¹ image analysis algorithm used with the VENTANA iScan Coreo scanner running Virtuoso software. This clearance completes Ventana's diagnostic package offering.

There are two intended uses obtained with this clearance for ER: first, clinical use of the software algorithm to semi-quantify the ER biomarker, and second, digital read, or clearance to manually read and score the ER biomarker using a computer monitor, in lieu of a microscope. This means the pathologist can digitally view a slide on a computer monitor, assign a score, and then sign out the case with a diagnosis or opinion, with or without the assistance of an image analysis algorithm.

All IHC breast markers in the Ventana portfolio have both image analysis and digital read application FDA 510(k) clearances. Along with the Companion Algorithm ER (SP1) image analysis software, the full panel includes HER2 (4B5), PR (1E2), Ki-67 (30-9) and p53 (DO-7) image analysis algorithms along with their accompanying VENTANA IHC assays.

"The biomarkers, scanner, and image analysis software have been optimized and clinically validated to work together as a system. Not only does this provide a powerful image analysis tool but an added level of clinical confidence," said Robert C. Babkowski MD, FCAP Chair, Department of Pathology and Laboratory Medical Director, the Stamford Hospital. "This most recent addition of the VENTANA ER (SP1) Companion Algorithm software to our digital pathology portfolio demonstrates our continued commitment to provide our customers with the most advanced, clinically validated, pathology solutions available," said Dr. Steve Burnell, vice president, Ventana Digital Pathology and Workflow. "Digital pathology is a transformational technology, delivering greater accessibility, confidence, and faster results to physicians and their patients," added Ventana President Mara G. Aspinall.


¹When the VENTANA ER (SP1) algorithm is used in conjunction with the CONFIRM anti-ER (SP1) Rabbit Monoclonal Primary Antibody test, it may be used as an aid in the assessment of ER status in breast cancer patients for whom endocrine treatment is being considered but is not the sole basis for treatment.

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