VANCOUVER, BRITISH COLUMBIA--(Marketwired - Jun 3, 2013) - Med BioGene Inc. (TSX VENTURE:MBI) today announced that its commercial partner, Precision Therapeutics, Inc., presented data regarding GeneFx® Lung at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois and also provided an update on the commercialization of GeneFx Lung.
The presentation at the ASCO Annual Meeting, titled "Performance of a Prognostic Genomic Signature for Early-Stage NSCLC in Matched Fresh Frozen and RNA-Stabilized Tissue," was presented on June 1, 2013. The presented data detailed the successful completion of the previously announced clinical studies to validate the use of GeneFx Lung with tissue preserved by RNAlater®, a molecular fixative.
The clinical study was undertaken by Precision Therapeutics of Pittsburgh, Pennsylvania, Almac Diagnostics Ltd. of Craigavon, Northern Ireland and the University Health Network and Princess Margaret Hospital of Toronto, Ontario.
With over 30,000 attendees, the ASCO Annual Meeting is one of the largest educational and scientific events in the oncology community. The five-day event provides a venue for physicians and scientists to present research results to a global audience of oncology professionals.
Sean McDonald, President and Chief Executive Officer of Precision commented: "The results from our study demonstrate the robustness of GeneFx Lung and highlight the exceptional work being done by our technicians and partner clinicians. Only a handful of genomic signatures in other disease areas have been validated across differing tissue platforms and so we were excited to present the results from our study."
RNAlater eliminates the need to flash-freeze specimens and to keep specimens frozen throughout storage and transport, a process that is cumbersome and costly and limits test adoption as many laboratories are not equipped to work with frozen specimens. It also eliminates the need for preserving tissue in formalin, which is known to cross-link and degrade the nucleic acids rendering them less suitable for specific downstream molecular applications.
A copy of the poster from the ASCO presentation will be available on MBI's website at www.medbiogene.com.
Successful completion of the clinical studies to validate the use of GeneFx Lung with tissue preserved by RNAlater, and the associated presentation of the data at the ASCO Annual Meeting, are significant milestones and allows Precision to move forward with commercialization under CLIA.
Commercialization of GeneFx Lung
Precision plans to commercialize GeneFx Lung under CLIA (Clinical Laboratory Improvement Amendments of 1988), the United States federal regulations applicable to clinical laboratory testing. In order to receive a CLIA-certificate relating to GeneFx Lung to allow for the commencement of commercial testing, Precision is required to complete certain "wet laboratory work" and associated data analysis demonstrating the analytical validity of the assay in Precision's laboratory. Precision has already completed the substantive analytical design for this work and expects the remaining laboratory work and data analysis to take approximately 12 to 14 weeks to complete. Precision anticipates receipt of their CLIA-certification and product launch shortly thereafter.
In anticipation of commercialization, Precision is integrating GeneFx Lung into its sales, marketing and reimbursement teams and will continue with its successful strategy of having their teams interact directly with surgeons, oncologists, pathologists and patient advocacy groups to convey the clinical and health economic benefits of their tests.
The long-term commercial success of GeneFx Lung will depend largely upon the extent to which third-party payers reimburse the test. In the United States, government insurers, such as Medicare and Medicaid, and third party insurers generally require evidence of both clinical validity (i.e. reliability of test results associated with the target disease) and clinical utility (i.e. whether the test results affect actual clinical decision-making) 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. In order to establish evidence of the clinical utility of GeneFx Lung, Precision is planning to initially commence commercialization of the test through a select group of top-tier clinical and academic institutions to assess the impact of the GeneFx Lung risk determination on physician treatment recommendations and patient care decisions. It is expected that this study will show that GeneFx Lung provides actionable information which affects the decisions of physicians and will provide to insurers compelling evidence of clinical utility. Precision is planning to undertake a broad national commercial roll-out of GeneFx Lung approximately three to six months from their initial focused launch of the test. The adoption and recommendation of the use of GeneFx Lung by these centers of excellence and their key opinion leaders in lung cancer is also expected to increase general awareness, acceptance and adoption of the test.
"Reimbursement of GeneFx Lung is critical to ensuring that lung cancer patients have access to this important technology and we are putting in place a substantive strategy to provide to public and private insurers clinical data that will meet their evidentiary requirements. We are successfully applying this strategy to GeneFx Colon, our gene expression-based test that predicts the risk of recurrence in patients diagnosed with stage II colon cancer, and are confident in taking the same approach with GeneFx Lung," noted Sean McDonald.
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.
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