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Ventana Companion Diagnostics CAP/CLIA lab launches new Robust Prototype Assays

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Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced the launch of three new companion diagnostic robust prototype assays (RPAs) for the detection of biomarkers PSMA, MDM2 and FGFR, offering biotech and pharmaceutical companies more options in exploring novel treatment options for patients with cancer. The new assays bring the company’s CAP/CLIA testing menu to almost 400, nearly 100 of which are RPA assays and the remainder are IVD approved Ventana tests.

Robust prototype assays are in vitro diagnostic tests used in biomarker identification that have been validated, manufactured and used within a single clinical laboratory. The key advantage of Ventana CAP/CLIA RPAs is that they adhere to the same rigorous quality standards as the company’s commercial, FDA-approved and Class I IVD assays. Biotech and pharmaceutical research development teams rely on RPAs when conducting early clinical studies to explore the potential value of specific biomarkers for a variety of indications. Data from these early research investigations can confirm, alter, or disprove a particular treatment hypothesis, saving companies valuable time and cost in bringing valuable cancer drugs to market to benefit patients.

PSMA (prostate specific membrane antigen)

PSMA is a cell surface protein that mediates signal transduction processes leading to cell migration. PSMA is expressed on the surface of most prostate tumor cells and increased levels of expression are associated with progressively higher grade tumors.

MDM2 ISH (mouse double minute 2)

MDM2 is a gene that encodes a protein that inhibits p53 activation and promotes progression through the cell cycle. Genetic amplifications of MDM2 are associated with aberrant progression through the cell cycle and the formation of neoplasms. Amplifications of the MDM2 gene are most commonly observed in soft tissue malignancies (sarcomas) and glioblastomas.

FGFR2 (fibroblast growth factor receptor 2)

FGFR2 is a receptor tyrosine kinase (RTK) that is responsible for mediating a number of intracellular processes culminating in cell growth and proliferation. Increased expression of FGFR2 protein has been observed in a number of human malignancies, including gastric, lung, ovarian, and breast cancers.

“High quality prototype assays for specific biotargets are a valuable tool for pharma early development,” says H. James Hnatyszyn, Ph.D., Director of Ventana CAP/CLlA Laboratory Operations. “Data from early clinical trials can help ensure that our pharma partners are pursuing strategies that will ultimately bring the most value to cancer patients.”

The Ventana CAP/CLIA lab is a full-service histopathology lab that employs automated staining platforms and validated assays for IHC and ISH staining of retrospective and prospective clinical samples. The laboratory’s goal is to support hypothesis testing during early phase drug development studies. Customers for these services include pharma development teams within the Roche group such as Genentech and Chugai, as well as external pharmaceutical companies that are interested in oncology biomarker evaluation and companion diagnostic development using tissue-based IHC and ISH assays.

The Ventana Companion Diagnostics (CDx) Pharma Services Team provides customers with a comprehensive suite of services in prototype assay development and validation, including antibody screening, analytical performance studies, validation report and IHC/ISH slide scoring by pathologists. Through the Ventana CAP/CLIA lab, clients have access to full anatomic pathology services in tissue processing, embedding, microtomy, primary staining, and advanced staining.

Source: Ventana