VANCOUVER, BRITISH COLUMBIA--(Marketwired - Feb. 5, 2014) - Med BioGene Inc. (TSX VENTURE:MBI) today provided an update on the regulatory approval process for GeneFx® Lung.
MBI's commercial partner, Precision Therapeutics, Inc., plans to offer GeneFx Lung testing under CLIA (Clinical Laboratory Improvement Amendments of 1988), the United States federal regulations applicable to clinical laboratory testing. Consistent with MBI's guidance outlined in its press releases of November 5 and 29, 2013, Precision submitted to CLIA in December 2013 for approval of GeneFx Lung the required data demonstrating the analytical validity of the test in Precision's laboratory. Precision expects a response from CLIA soon in respect of its application.
About GeneFx Lung
GeneFx Lung is a proprietary gene expression-based test to improve upon staging for identifying those patients with early-stage non-small-cell lung cancer (NSCLC) who, following surgical removal of their tumor, are at higher and lower risks of mortality. In an initial study of patient specimens from the National Cancer Institute of Canada Clinical Trials Group JBR.10 trial, published in the Journal of Clinical Oncology, patients classified by GeneFx Lung as higher risk benefited from adjuvant chemotherapy, and those classified as lower risk did not benefit and may have experienced a detrimental effect from adjuvant chemotherapy. GeneFx Lung was subsequently validated in predicting patient mortality in four independent studies involving data from tumor specimens totaling 676 untreated early-stage NSCLC patients. GeneFx Lung is expected to provide better-informed and personalized treatment decisions to assist in the selection of patients for adjuvant chemotherapy.
On April 15, 2011, Precision and MBI closed their commercialization, license and research reimbursement agreement. The agreement provides to Precision exclusive global rights to develop and commercialize GeneFx Lung.
About Precision Therapeutics
Precision, a leading life science company based in Pittsburgh, Pennsylvania, is dedicated to improving the outcomes of cancer patients by providing personalized medicine solutions that aim to increase quality of life and cancer survival rates. Precision offers a portfolio of products developed to help guide physicians and patients with difficult clinical decisions throughout the continuum of cancer care.
Precision currently markets a number of tests through its CLIA-certified laboratory, including ChemoFx®, BioSpeciFx®, GeneFx® Colon and the Rosetta Genomics Cancer Origin Test®.
For more information on Precision, please visit www.precisiontherapeutics.com.
About Med BioGene
MBI is a life science company based in Vancouver, British Columbia that is currently focused on managing the license and rights to GeneFx Lung. MBI's common shares are listed for trading on the TSX Venture Exchange.
For more information on MBI, please visit www.medbiogene.com.
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
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Erinn B. Broshko