PITTSBURGH, PENNSYLVANIA and VANCOUVER, BRITISH COLUMBIA -- (Marketwire) -- 01/23/13 -- Precision Therapeutics, Inc. and Med BioGene Inc. (TSX VENTURE: MBI) today announced that Precision Therapeutics has successfully completed their previously announced clinical studies to validate the use of LungExpress Dx with tissue preserved by RNAlater®, a molecular fixative.
RNAlater eliminates the need to flash-freeze specimens and to keep specimens frozen throughout storage and transport, a process that can be cumbersome and costly. 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.
The clinical studies were conducted using patient specimens prospectively accrued by Precision from a consortium of medical centers in the United States.
Precision expects to commence commercialization of LungExpress Dx in its CLIA-certified laboratory by mid-2013. In advance of commercialization, Precision has established an advisory board comprised of world leaders in lung cancer research and treatment from the United States, Canada, France and Italy.
"Precision's efforts in commercializing this important test underscores our ongoing commitment to improving the outcomes of cancer patients by providing personalized medicine solutions that aim to increase quality of life and cancer survival rates," said Sean McDonald, Precision's President and Chief Executive Officer. "The successful completion of our clinical studies provides further evidence of the robustness of our test and we are moving closer to providing patients and doctors with a tool to address a critical unmet need."
Erinn Broshko, Executive Chairman of Med BioGene, commented: "We are very pleased with the progress made by Precision and are looking forward to our clinically valuable test being available to lung cancer patients. The commercial success of a molecular diagnostic test depends, in large measure, upon the extent of its integration into current pathological processes. The use of LungExpress Dx with RNAlater will allow pathologists to avoid the logistics involved with using flash-frozen tumor specimens and, instead, to handle and ship specimens at room temperature, thereby simplifying the process significantly. We believe that this will materially enhance the commercial prospects of our test."
About LungExpress Dx
LungExpress Dx 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 LungExpress Dx 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. LungExpress Dx was subsequently validated in predicting patient mortality in four independent studies involving data from tumor specimens totaling 676 untreated early-stage NSCLC patients. LungExpress Dx is expected to provide better-informed and personalized treatment decisions to assist in the selection of patients for adjuvant chemotherapy.
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