Med BioGene Announces Regulatory Approval of GeneFx(R) Lung
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.
Certain statements in this press release contain
forward-looking statements and information ("forward-looking
statements") under applicable United States and Canadian securities
legislation. Words such as "anticipates," "believes," "estimates,"
"expects," "intends," "may," "plans," "projects," "will," "would"
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
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and/or results of clinical trials or studies, the timing for
commercialization of any products, future profits, future product
revenues, future shareholder value, future operations and plans,
the completion and use of proceeds from transactions or financings
and the prospects for negotiating partnerships or collaborations
and their timing. These forward-looking statements are only a
prediction based upon the party's current expectations, and actual
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to known and unknown risks and uncertainties and are based on
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undue reliance on these forward-looking statements, which speak
only as of the date of this press release. A party's
forward-looking statements do not reflect the potential impact of
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result of new information, future events or otherwise after the
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of Precision and its scientific, clinical and/ or commercialization
efforts have been provided to MBI by Precision. MBI may not have
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forward-looking statements. A redacted copy of the
commercialization agreement, as amended, between Precision and MBI
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to its holder.
Med BioGene Inc.Erinn B. BroshkoExecutive Chairman(800)
641-3593ebroshko@medbiogene.comwww.medbiogene.com
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