Med BioGene Provides GeneFx(R) Lung Regulatory Update
February 05 2014 - 8:30AM
Marketwired
Med BioGene Provides GeneFx(R) Lung Regulatory Update
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.
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
these identifying words. Forward looking statements include, but
are not limited to, that with respect to the timing, completion
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
events or results may differ materially. A party may not actually
achieve the plans, intentions or expectations disclosed in its
forward-looking statements. Forward-looking statements are subject
to known and unknown risks and uncertainties and are based on
uncertain assumptions that could cause a party's actual results and
the timing of events to differ materially from those anticipated in
such forward-looking information. You are cautioned not to place
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
any future partnerships, collaborations, acquisitions, mergers,
dispositions, joint ventures or investments that that party may
make. All forward-looking statements are qualified in their
entirety by this cautionary statement and a party undertakes no
obligation to revise or update any forward-looking statements as a
result of new information, future events or otherwise after the
date of this press release, other than as required by applicable
law. Certain information included in this press release in respect
of Precision and its scientific, clinical and/ or commercialization
efforts have been provided to MBI by Precision. MBI may not have
been able to confirm the accuracy of such information and you
should not place undue reliance on any such information, including
any information regarding Precision that would constitute
forward-looking information. A redacted copy of the
commercialization agreement, as amended, between Precision and MBI
may be found at www.sedar.com. Each trademark, trade name or
service mark of any entity appearing in this news release belongs
to its holder.
Med BioGene Inc.Erinn B. BroshkoExecutive Chairman(800)
641-3593ebroshko@medbiogene.comwww.medbiogene.com
Med Biogene (TSXV:MBI)
Historical Stock Chart
From Oct 2024 to Nov 2024
Med Biogene (TSXV:MBI)
Historical Stock Chart
From Nov 2023 to Nov 2024