Ventana Medical Systems, a member of the Roche Group, has obtained the US Food and Drug Administration’s (FDA) 510(k) approval for its Companion Algorithm ER (SP1) image analysis algorithm used with the Ventana iScan Coreo scanner running Virtuoso2 software.
Ventana obtained the 510(k) approval for the system for two intended uses that include clinical use of the software algorithm to semi-quantify the estrogen receptor (ER) biomarker, and digital read, or clearance to manually read and score the ER biomarker using a computer monitor, in lieu of a microscope.
The Companion Algorithm ER (SP1) image analysis software clearance completes the company's breast diagnostic portfolio, providing physicians with the FDA-cleared testing package of five key immunohistochemistry (IHC) breast markers with their corresponding image analysis algorithms and digital read applications for cancer patients.
Ventana Digital Pathology and Workflow vice president Dr Steve Burnell noted this most recent addition of the Ventana ER (SP1) Companion Algorithm software to the company's digital pathology portfolio demonstrates its continued commitment to provide its customers with the most advanced, clinically validated, pathology solutions available.
"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," Dr Burnell added.
All IHC breast markers in the Ventana portfolio have both image analysis and digital read application 510(k) clearances.
In addition to 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 the company's accompanying Ventana IHC assays3.
According to Ventana, the Ki-67 protein test and p53 genetic mutation test are known to be excellent markers for cellular proliferation.
