VANCOUVER, BRITISH COLUMBIA--(Marketwired - Mar 24, 2014) - Med BioGene Inc. (TSX VENTURE:MBI) today announced that its commercial partner, Precision Therapeutics, Inc. has received regulatory approval of GeneFx® Lung under CLIA (Clinical Laboratory Improvement Amendments of 1988), the United States federal regulations applicable to clinical laboratory testing. With this approval, Precision may undertake testing of GeneFx Lung in its CLIA-certified clinical laboratory in Pittsburgh, Pennsylvania.
Erinn Broshko, Executive Chairman of MBI commented: "We are obviously very pleased with the receipt of regulatory approval of GeneFx Lung. This reflects the completion of yet another major milestone along the pathway to commercialization and we are looking forward to making this important test available to patients and their physicians."
"Not all patients benefit from chemotherapy and not all patients require chemotherapy after surgery. Knowing that a patient has a genetic signature for a more aggressive cancer and that their chance of a cure may be improved with chemotherapy gives patients and their doctors a clearer picture of the need for post-operative treatment. We believe that GeneFx Lung will provide a fuller understanding of each patient's risk of cancer recurrence after surgery, resulting in better-informed, more appropriate treatment decisions," further noted Mr. Broshko
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, payors 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 analytical and clinical validity of GeneFx Lung from peer-reviewed publications that 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. Also, specific payors have recently declined coverage of some molecular diagnostic tests citing a lack of evidence of clinical utility in the submissions.
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 they apply 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. As such, the timing of the commercial launch of GeneFx Lung will be established by Precision in light of these considerations.
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 high risk benefited from adjuvant chemotherapy, and those classified as low risk did not benefit and may have experienced a detrimental effect from adjuvant chemotherapy. In the same study, GeneFx Lung was validated in predicting patient mortality in four independent studies involving data from tumor specimens totaling 375 untreated early-stage NSCLC patients. As published in the Journal of Thoracic Oncology, GeneFx Lung was also independently validated in a prospective and blinded manner in predicting patient mortality in a study of 181 specimens from untreated 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 Therapeutics, 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® and GeneFx® Colon.
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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