Med BioGene Inc. (TSX VENTURE:MBI) today announced that its commercial partner,
Precision Therapeutics, Inc. has received regulatory approval of GeneFx(R) 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(R), BioSpeciFx(R) and GeneFx(R) 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 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 statements. 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.


FOR FURTHER INFORMATION PLEASE CONTACT: 
Med BioGene Inc.
Erinn B. Broshko
Executive Chairman
(800) 641-3593
ebroshko@medbiogene.com
www.medbiogene.com

Med Biogene (TSXV:MBI)
Historical Stock Chart
From Apr 2024 to May 2024 Click Here for more Med Biogene Charts.
Med Biogene (TSXV:MBI)
Historical Stock Chart
From May 2023 to May 2024 Click Here for more Med Biogene Charts.