MBI Med Biogene Inc

Med BioGene Inc. (TSX VENTURE:MBI) today provided an update on the regulatory
and commercialization plans for GeneFx(R) 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.
In order to receive CLIA approval for GeneFx Lung, Precision is completing the
required "wet laboratory work" and associated data analysis demonstrating the
analytical validity of the assay in Precision's laboratory. The analytical work
completed to date has been successful and has shown the expected results.
Primarily as a result of feedback from New York State, Precision is planning to
undertake certain other laboratory work that is expected to add approximately
three weeks to the completion date of the overall analytical laboratory work. As
such, Precision anticipates submitting the required data to CLIA in December. As
Precision's clinical laboratory is already CLIA-certified, approval for GeneFx
Lung is expected reasonably soon thereafter. This timeline relating to the CLIA
submission and receipt of approval is Precision's current best estimates;
however, given the short timeframe, unforeseeable events, even if minor, may
result in delays.


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, insurers 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 clinical validity of
GeneFx Lung from existing and in-process peer-reviewed publications which
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. Published recommendations
earlier in the year from The Center for Medical Technology Policy, an
independent, non-profit think tank, relating to the evidentiary requirements to
demonstrate clinical utility, combined with recent decisions of specific payors
to not cover certain molecular diagnostic tests due to their submissions lacking
evidence of clinical utility, seems in aggregate to indicate an increase in
evidentiary requirements. 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 it applies 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.


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(R), BioSpeciFx(R), GeneFx(R) Colon and
miRview(R)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. 

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.


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

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