Scottsdale, AZ, May 7, 2013 (GLOBE NEWSWIRE) -- Provista Diagnostics, Inc., a leading molecular diagnostics company focused on developing and commercializing proprietary diagnostic, prognostic and predictive tests for cancers affecting women is pleased to announce that it has been licensed to offer clinical laboratory services for samples originating within the State of Florida following the approval for an Out of State Laboratory License to Provista Diagnostics by the Clinical Laboratory Unit of the Florida Agency for Healthcare Administration.
Laboratory services are offered through the Company's PDx Reference Laboratory, which is fully CLIA-accredited through theCenters for Medicare and Medicaid Services (CMS). Services include a comprehensive menu of testing services, such as consultation, assay evaluation and development, method development, clinical laboratory services, clinical trial design and diagnostic support, analytical regulatory guidance and companion diagnostics.
Later this year, the Company plans to submit an application along with supporting test documentation to the College of American Pathologists (CAP) for increased Lab Accreditation documenting a stringent quality program that exceeds regulatory requirements. An additional application will be submitted to the New York State Department of Health, Clinical Laboratory Evaluation Program ("CLEP"), to offer Out of State Clinical Lab services to New York State residents. Once New York State approval is granted Provista will have been licensed to offer clinical laboratory services in all 50 U.S. States.
Provista Diagnostics, Inc. is a privately held molecular diagnostics company focused on developing and commercializing proprietary diagnostic, prognostic and predictive tests for cancers affecting women, including breast, endometrial and ovarian. ProvistaDx also offers diagnostic testing and clinical laboratory services to the pharmaceutical and biotechnology industries through its PDx Reference Laboratory, a CLIA-accredited and GLP capable laboratory, licensed in 49 states to perform human clinical testing. Provista Diagnostics invites interested readers to visit our website at www.provistadx.com to find out more about the Company and our technology.
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.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Provista's actual results may differ materially due to a number of factors, many of which are beyond Provista's ability to predict or control, including among others, viability and effectiveness of our sales approach and overall marketing strategies, the outcome of development or regulatory review of our products, commercial success or acceptance by the medical community, competitive responses, our ability to raise additional capital, and the ability to successfully file a registration statement with the SEC. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. Provista operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Provista undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
CONTACT: John N. Fermanis +1 602 224 5500 firstname.lastname@example.org
Source:Provista Diagnostics, Inc.