Ventana Medical Systems, a Roche (PINK:RHHBY) subsidiary, landed 510(k) clearance from the FDA for the Companion Algorithm image analysis software.
The software is used in conjunction with the Ventana iScan Coreo scanner. The software has been cleared for 2 uses: clinical use, to semi-quantify the ER biomarker; and digital use, to manually read and score the ER biomarker in lieu of a microscope.
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 breast markers," according to a press release.
“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," digital pathology and workflow VP Dr. Steve Burnell said in prepared remarks. "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."
The Tuscon, Ariz.-based company was acquired by Roche in 2008 for $3.4 billion.
