Med BioGene (TSX-V:MBI, StockForum), a Vancouver-based life science firm engaged in the development and commercialization of genomic-based clinical laboratory diagnostic tests, announced today that the under Clinical Laboratory Improvement Amendments (“CLIA”), its GeneFx(R) Lung may undergo clinical testing at its CLIA-certified clinical laboratory located in Pittsburgh, Pennsylvania.
According to the news release, “The long-term commercial success of GeneFx Lung will depend largely upon the extent to which government payers, such as Medicare and Medicaid, and other third-party payers reimburse the test.”
It went on to explain, “In the United States, payers 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.”
Company Executive Chairman, Erinn Broshko, 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.”
He went on to explain, “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.”
And then he finally concluded, “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.”
Med BioGene was in the news recently when the company published data that independently validated the GeneFx(R) Lung at the top of the month.
Shares climbed 10.00% on the news to $0.11 per share.
Currently there are 77.6m outstanding shares with a market cap of $8.5 million.