VANCOUVER, BRITISH COLUMBIA--(Marketwired - Nov 5, 2013) - Med BioGene Inc. (TSX VENTURE:MBI) today provided an update on the regulatory and commercialization plans 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. In order to receive CLIA approval for GeneFx Lung, Precision is completing the required "wet laboratory work" and associated data analysis demonstrating the analytical validity of the assay in Precision's laboratory. The analytical work completed to date has been successful and has shown the expected results. Primarily as a result of feedback from New York State, Precision is planning to undertake certain other laboratory work that is expected to add approximately three weeks to the completion date of the overall analytical laboratory work. As such, Precision anticipates submitting the required data to CLIA in December. As Precision's clinical laboratory is already CLIA-certified, approval for GeneFx Lung is expected reasonably soon thereafter. This timeline relating to the CLIA submission and receipt of approval is Precision's current best estimates; however, given the short timeframe, unforeseeable events, even if minor, may result in delays.
The long-term commercial success of GeneFx Lung will depend largely upon the extent to which government payors, such as Medicare and Medicaid, and other third-party payors reimburse the test. In the United States, insurers generally require evidence of both analytical and clinical validity (i.e. reliability of test results associated with the target disease) as well as clinical utility (i.e. whether the test results affect actual clinical decision-making and, possibly, improve patient outcomes) before reimbursing for a molecular diagnostic test.
Precision believes that it has sufficient evidence of the clinical validity of GeneFx Lung from existing and in-process peer-reviewed publications which demonstrate the prognostic power of the test.
The evidentiary requirements of payors in the United States relating to the clinical utility of high-value molecular diagnostic tests, which includes GeneFx Lung, has varied over the last couple of years as among the numerous Medicare contract administrators who make coverage determinations within their jurisdictions, and as among other third-party payors. Published recommendations earlier in the year from The Center for Medical Technology Policy, an independent, non-profit think tank, relating to the evidentiary requirements to demonstrate clinical utility, combined with recent decisions of specific payors to not cover certain molecular diagnostic tests due to their submissions lacking evidence of clinical utility, seems in aggregate to indicate an increase in evidentiary requirements. In advance of the commercial launch of GeneFx Lung, Precision plans to engage in further dialogue with payors to better understand the current landscape and the specific needs of relevant payors as it applies to GeneFx Lung and will incorporate this into their launch strategy in order to ensure that efforts are aimed to provide clinical utility data that satisfies payors' requirements.
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 miRview®mets2.
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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