The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ventana Medical Systems' Companion Algorithm ER (SP1) image analysis algorithm used with the Ventana iScan Coreo scanner running Virtuoso software. With this clearance, Ventana is now the only company in the industry offering a comprehensive portfolio of FDA-cleared image analysis algorithms and digital read applications for the five key immunohistochemistry (IHC) breast markers.

There are two intended uses obtained with the 510(k) 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 will be able to 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 breast 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," says 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," says Dr. Steve Burnell, vice president, Ventana Digital Pathology and Workflow. "It represents another significant step by Ventana in assisting pathologists with the consistent and objective interpretation of these important breast cancer biomarkers, supporting the highest standards of patient care."

Hormone receptor status is a main factor in planning breast cancer treatment. The presence or absence of estrogen receptor (ER) and progesterone receptor (PR) status in cancer cells, along with HER2 receptor status, help guide treatment options. The Ki-67 protein test and p53 genetic mutation test are known to be excellent markers for cellular proliferation.

"Digital pathology is a transformational technology, delivering greater accessibility, confidence and faster results to physicians and their patients," says Ventana president Mara G. Aspinall.

Ventana Medical Systems, Inc., a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics.