Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Companion Algorithm ER (SP1)1 image analysis algorithm used with the VENTANA iScan Coreo scanner running Virtuoso2 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 assays3.
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.
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 the components of the VENTANA laboratory workflow solution including the company’s BenchMark IHC/ISH slide stainer, exclusive HER2 (4B5), PR (1E2), ER (SP1), and Ki-67 (30-9) clones, detection systems, iScan slide scanner, and Virtuoso software.
3. The PATHWAY HER2 (4B5) assay is FDA-approved, the CONFIRM PR (1E2) and CONFIRM ER (SP1) assays are FDA-cleared, and Ki-67 (30-9) and p53(DO-7) assays are FDA class 1, exempt in vitro diagnostics.