![]() ![]() “As more anatomic pathology laboratories routinely digitize patient slides, it’s important that the most critical and commonly prepared stain-the H&E-can be reliably scanned and interpreted by a pathologist using a computer monitor for primary diagnostic purposes,” said Dr. This new CE mark for their application in routine pathology including primary diagnosis takes digital pathology a big step forward by expanding diagnostic options for a lab’s most common test-the Hematoxylin and Eosin (H&E)-while improving workflow, physician collaboration and the standard of patient care. The system, consisting of VENTANA Virtuoso software coupled with either the VENTANA iScan Coreo or the VENTANA iScan HT slide scanner, provides automated digital slide creation, case management and computer viewing of human tissue specimens. (Ventana), a member of the Roche Group, today announced that its VENTANA System for Primary Diagnosis1 has been CE marked in the European Union for routine pathology, including primary diagnosis with human tissue specimens. New CE mark in the European Union extends application to routine pathology including primary diagnosis with human tissue specimens Perkins Coie Office Hours (Busines Law).Booth Udall Fuller Office Hours (IP Law).How a Professional Employer Org (PEO) Can Support Your Business.Looking Back at Arizona Bioscience Week 2022 (Video).Join Us in Shaping AZBio’s 20th Anniversary Celebration. ![]() 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. 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.ģ. 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. 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.Ģ. The Ki-67 protein test and p53 genetic mutation test are known to be excellent markers for cellular proliferation.ġ. 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. Hormone receptor status is a main factor in planning breast cancer treatment. 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. 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.Īll IHC breast markers in the Ventana portfolio have both image analysis and digital read application FDA 510(k) clearances. 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. ![]() (PRNewsFoto/Ventana Medical Systems, Inc.) VENTANA Companion Algorithm ER (SP1)image analysis algorithm. ![]()
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