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Med BioGene Will Launch LungExpress Dx in H2, Establish US Office, CEO Says

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Med BioGene, a Vancouver, BC-based firm developing a test to stratify lung cancer patients, last week said that it has extended its biomarker collaboration with the University Health Network in Toronto.

The deal expands the firm's previous exclusive license and collaboration with UHN, which will provide additional gene expression-based markers for its early-stage non-small-cell lung cancer test.

According to CEO Erinn Broshko, Med BioGene is on track to launch its LungExpress assay in the second half of this year and will likely open a US office to support the test, which will initially be offered in a Clinical Laboratory Improvement Amendment-compliant partner lab.

"Our intentions are to launch this test in the second half of the year under CLIA in the US and then run it in a central reference lab," Broshko told BioArray News this week. "The first move will be in the US, though Canada is on the list, as is obviously the EU and Asia. We are still working through the nuances of the approach for launching the test in different jurisdictions."

Broshko said that Med BioGene is leaning towards a CLIA partnership model, where a CLIA partner lab will perform the "wet lab" work and Med BioGene will control the running of the prognostic algorithm, sales, marketing, and reimbursement. Broshko said that the company is simultaneously scouting locations for a US office, from where the "dry work" of LungExpress will be coordinated.

Eventually, the firm plans to have its own CLIA-certified lab and is "working towards getting that certificate," but it "makes sense for us to do this because it allows us to move more quickly into the US market," Broshko said. A 510(k) submission to the US Food and Drug Administration is also under consideration, though Broshko said that Med BioGene's first priority is to launch the assay via a CLIA lab in the US market.

LungExpress Dx is a 15-gene expression-based prognostic for survival and is predictive of adjuvant chemotherapy benefit for early-stage NSCLC. It is intended to classify patients into high- and low-risk groups based upon the molecular profile of their tumors. The test is expected to be used to improve the selection of patients beyond current clinical parameters, such as stage and histology, for adjuvant chemotherapy, according to the firm.

UHN provided data at the 2008 meeting of the American Society of Clinical Oncology that it claimed shows that by better selecting patients for adjuvant chemotherapy, LungExpress Dx has the potential to increase the five-year survival rate by up to 33 percent while decreasing health care costs significantly.

The main reason for the expected cost savings is a decrease in treatment failure and terminal care costs associated with cancer recurrence, which in the United States can range between $150,000 to $500,000 per patient, the firm claims.

The LungExpress Dx signature was originally developed on Affymetrix's GeneChip platform, but because of the low number of markers and in order to reduce the price of the assay, Med BioGene has opted to transfer the signature to a Taqman RT-PCR assay manufactured by Applied Biosystems, part of Life Technologies.

"The underlying signature was developed using Affymetrix microarrays, but with PCR, you get a better dynamic range," Broshko said. "More importantly, [PCR] is an assay that basically every lab has access to, and the cost basis is much lower than running a microarray," he said. "Lastly, it's easier to develop a PCR assay for robust use with formalin-fixed, paraffin-embedded tissue samples than using it with a microarray," he added.

According to Broshko, Med BioGene originally had research programs focused on lymphoma and cardiovascular diseases but opted to in-license IP from UHN related to NCSLC because of both the clinical need for such a prognostic as well as a perceived quicker route to market.

"Given the nature of hematological diseases and different subtypes, it was a longer pathway than we were comfortable with looking at a short term to market," said Broshko. "One thing that drove us to focus on NCSLC, aside from a serious unmet need in lung cancer to select patients for chemotherapy, is that, logistically, you are not looking at 25 different subtypes of disease," Broshko said.

Med BioGene have already developed and validated the test on around 400 samples with partners at Princess Margaret Hospital in Toronto, who include Ming-Sound Tsao and Frances Shepherd. Now, using both the Affy and Taqman platforms, Med BioGene and its partners will complete the process of validating its assays on between 200 and 300 samples by the end of May. By the end of August, the firm hopes to have its Taqman assay validated in both frozen and FFPE samples, Broshko said.

“Not all patients benefit from chemotherapy and not all patients require chemotherapy after surgery," Tsao said in a statement. "Knowing that a patient has a genetic signature for a more aggressive cancer and that their chance of cure may be improved with chemotherapy gives patients and their doctors a clearer picture of the need for post-operative treatment.”

Once it hits the market, Med BioGene's test will compete against older methods and technologies, such as clinical staging or single-marker assays. "The strongest predictor of prognosis is still staging, but it's unfortunately a very rough indicator," Broshko said. "There has been also increased use of single markers looking at EGFR [and] KRAS, but nothing that has been substantially adopted. In terms of other gene-expression signatures for NCSLC, we are the only group with a signature predictive of adjuvant chemotherapy benefit and prognostic for survival."

Beyond LungExpress, Med BioGene is still interested in developing its hematology and cardiovascular programs. At the same time, Broshko said that most of the firm's resources are being spent on launching its first test. "We have been in discussions with a number of groups in terms of acquiring further technology and looking at the programs that we have started to date," he said.

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