CAP/CLIA Lab Launches New Robust Prototype Assays

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.

Mouse double minute 2 (MDM2 ISH) 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.

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.

The new assays bring the company's College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) testing menu to almost 400, nearly 100 of which are RPA assays and the remainder are in vitro diagnostic (IVD) approved Ventana (Tucson, AZ, USA) 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, US Food and Drug Administration (FDA; Silver Spring, MD USA)-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.

H. James Hnatyszyn, PhD, director of Ventana CAP/CLlA laboratory operations said "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. High quality prototype assays for specific biotargets are a valuable tool for pharma early development."

The Ventana CAP/CLIA lab is a full-service histopathology lab that employs automated staining platforms and validated assays for Immunohistochemistry (IHC) and in situ hybridization (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.

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US Food and Drug Administration