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OncoMethylome Becomes MDxHealth, Sharpens Focus on Molecular Dx for Cancer

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Durham, NC-based OncoMethylome Sciences has changed its name to MDxHealth as part of a shift in its business strategy away from biomarker discovery and toward the development of molecular diagnostics for personalized medicine.

MDxHealth said it will leverage its DNA methylation platform to develop and commercialize molecular diagnostic, prognostic, and predictive tests for cancer patients.

The company said that its "new direction will move MDxHealth away from its historical focus on discovery and out-licensing of biomarkers for screening applications."

According to the company, the time is ripe for it to step out as a molecular diagnostics developer since DNA methylation markers have become increasingly important in cancer research. "While basic research is continuing, the number of clinical studies and publications in the field of methylation has risen exponentially," it said.

Specifically, MDxHealth will focus on developing diagnostics in prostate, colon, and lung cancer. The assays will be developed to prognose patients with cancer and predict their response to treatments. In order to commercialize these tests, MDxHealth is initially planning to collaborate with "established clinical laboratories with a strong presence in the US market."

Additionally, MDxHealth plans to become a clinical trial services provider, as well as a companion diagnostics partner for drug firms developing cancer treatments.

The company's biomarkers "are well suited to aid in stratification of patients, which can reduce drug development costs, timelines, and increase efficacy by identifying those patients who are most likely to respond to new therapies," MDxHealth stated.

According to the firm, it has companion diagnostic biomarkers in brain, breast, lung, and colon cancer.

Last month, GlaxoSmithKline and then OncoMethylome announced they would work together to "potentially use" one of OncoMethylome's DNA methylation-specific PCR biomarkers to personalize a drug in GSK's immunotherapy development program (PGx Reporter 08/29/10).

MDxHealth's first companion diagnostic test is currently in a Phase III FDA trial with Merck Serono's drug cilengitide for brain cancer. The deal with Merck to provide an MGMT gene promoter methylation test for cilengitide was announced last year (PGx Reporter 09/09/09).

According to its 2010 interim financial report, MDxHealth also has entered into an agreement with Roche for MGMT gene promoter methylation testing in a Phase III clinical trial for the use of Avastin in newly diagnosed glioblastoma brain tumors.

Throughout next year, MDxHealth will focus on validating its tests and establishing a marketing channel through a CLIA-certified lab.

First out of the gate, the company expects to commercialize a test for prostate cancer. "Results from ongoing validation studies show excellent performance of MDxHealth's prostate test compared to technologies and products currently on the market," according to the company.

Slated next for launch is a lung cancer recurrence assay for which data has already been published in the New England Journal of Medicine. "Lung cancer represents a large underserved market, in which MDxHealth's methylation profiles may have a positive impact," the company said.

Additionally, MDxHealth is developing a DNA methylation test to predict response to colorectal cancer treatments. According to the firm's estimates, its combined products will potentially address a market with a revenue potential of more than $1 billion annually.

The company has had a flurry of new appointments in light of the change in its strategic direction.

Since April, Jan Groen, formerly president of Agendia, has been leading the company as CEO. Additionally, Christopher Thibodeau has been appointed as the VP of commercial operations. Melissa Thompson will serve as VP of regulatory and quality affairs, and James Clark will be VP of research and development.

Additionally, in May, the company appointed several new members to its board of directors, including Edward Erickson, Mark Myslinski, and Hilde Windels.

In its half-year financials, released in August, MDxHealth forecast that revenues for the second half of the year would likely remain "stable" compared to the previous year. The company expected "an increase in commercial revenues" to offset a projected decrease in grant revenues.

For the six months ended June 30, MDxHealth reported revenues of approximately €1.3 million ($1.7 million), level with the year-ago period.

Furthermore, the company expected to decrease operating costs by 20 percent, "although these may be impacted by one-time charges in connection with the consolidation of our facilities and related operations."

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