Provista Diagnostics, Inc. Expands Its Contract Research Offerings Through Its Provista Dx Reference Laboratory
Scottsdale, Arizona (GLOBE NEWSWIRE) - Provista Diagnostics, Inc., a leading molecular diagnostics company, is pleased to announce the addition of new contract research services and technologies to be offered to the pharmaceutical and biotechnology industries by its Provista Dx Reference Laboratory. These new services, combined with the company's existing complement of development and testing services, allow Provista to offer its customers a complete solution to their laboratory needs, including consultation, assay evaluation and development, method development, clinical laboratory services, clinical trial design and diagnostic support, analytical regulatory guidance and companion diagnostics. Furthermore, the Provista Dx Reference Laboratory offers a comprehensive array of technologies, such as qualitative and quantitative immunohistochemistry, advanced protein analysis (ELISA, Luminex and MSD) and next generation sequencing (Real Time qPCR, Ion Torrent).
The Provista Dx Reference Laboratory, which is both CLIA-accredited and GLP capable, is licensed in 48 states to perform human clinical testing and offers a comprehensive menu of testing services, including custom projects, companion diagnostics and clinical trial support. The laboratory is managed by experienced research, method development, clinical and commercial laboratory scientists and has a strong Quality Management Program with significant training requirements for all staff members. The laboratory scientists have expertise in assessing, evaluating and bringing new analytical technologies to the commercial marketplace. In addition, Provista is committed to adhering to this same level of quality as it expands the capabilities of its New York City facility.
Building upon the experience of management, the laboratory and its staff has enabled Provista Diagnostics to adopt a two-pronged commercialization strategy. This strategy allows Provista to align its resources to provide validation and development services needed for companion diagnostics, clinical trial support and other custom projects, and also to continue to pursue the development and commercialization of its own proprietary diagnostic, prognostic and predictive tests for women's cancers, including breast, endometrial and ovarian. With the company's current offerings, a series of recent hires to complement the experienced staff, and a strong Scientific Advisory Board comprised of recognized leaders in the fields of oncology and biomarker research, Provista Diagnostics is rapidly becoming a highly regarded, world class laboratory facility.
Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. The objective of CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. A CLIA lab is a laboratory that operates under CLIA supervision and is defined as a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings. In total, CLIA covers approximately 225,000 laboratory entities, most located in the United States.
About Provista Diagnostics, Inc.
Provista Diagnostics, Inc., a Delaware corporation, offers comprehensive testing services through its CLIA-accredited Provista Dx Reference Laboratory to support the development of companion diagnostics and clinical trials, while developing and commercializing breakthrough, easy to administer blood-based diagnostic tests for early oncology-related disease state recognition and detection purposes. Near term development and commercialization efforts focus on women's cancers such as breast, endometrial and ovarian cancer.
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SOURCE: Provista Diagnostics, Inc.