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Ventana receives FDA clearance for Estrogen Receptor (ER) Image Analysis and Digital Read Application for breast cancer
Date:12/5/2013

werful 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.

1 When 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. 

2 Virtuoso software is part of a 510(k)-cleared system with the HER2 (4B5), PR (1E2), Ki-67 (30-9), ER (SP-1) and p53 (DO-7) Companion Algorithm image analysis software. The FDA clearance includes all of
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SOURCE Ventana Medical Systems, Inc.
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