Saturday, August 30, 2014

MDxHealth strengthens position in epigenetics testing

March 5, 2013 by · Leave a Comment 

After launching a breakthrough epigenetics diagnostic for prostate cancer in the U.S. last May, Belgium-based MDxHealth (NYSE Euronet:MDXH), with U.S. headquarters in Irvine, Calif., continues to demonstrate strong scientific data for its ConfirmMDx molecular test and its economic benefits.

Dr. Jan Groen

Dr. Jan Groen

“As many as one-in-four men are misdiagnosed with a false-negative biopsy result but have hidden prostate cancer,” president and CEO Dr. Jan Groen says in an interview with BioTuesdays.com. “Our test can help urologists distinguish patients who have a true-negative biopsy from those who may have cancer.”

As a result, the test can help rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and rule in those men who may require repeat biopsies and potential treatment.  “We also can provide prostate mapping of positive methylation results to guide repeat biopsy, because it is important that urologists know the likely location of the cancer.”

Last month, the Journal of Urology published results of an efficacy study for ConfirmMDx, which received high marks from analysts.

In the study, researchers in Scotland confirmed that the biomarkers can identify a “halo” associated with the presence of cancer in adjacent negative biopsies and which may be indicative of aggressive prostate cancer. This epigenetic “halo” around a cancer lesion can be present despite displaying a normal appearance under the microscope.

Another study presented at the ASCO GU conference indicated that combining ConfirmMDx with other tests of a first biopsy resulted in an improved prediction of the presence of aggressive prostate cancer, with a sensitivity of 74% and negative predictive values of 91%.

In a research report last month, Roderick Verhelst, an analyst with Petercam in Belgium, said that the studies provide further evidence that DNA methylation-based tests are the way of the future in improving the diagnosis and subsequent treatment of cancer patients. “MDxHealth is on the forefront of this field and thus excellently positioned to benefit from this,” he added.

In epigenetics, scientists seek to understand how environmental influences on genes can be used to predict people’s risk of developing disease. Epigenetic changes are inherited changes to the DNA molecules that don’t affect the actual sequence of DNA. They have been described as “Post-it Notes” on genes that, over time, can lead to cancer.

The performance of the ConfirmMDx test has been demonstrated in more than 42 published studies.  It has been tested on some 5,000 patients at leading U.S. and European academic medical institutions. The test uses a proprietary three-gene epigenetic assay consisting of GSTP1, APC and RASSF1.

“As a global leader in epigenetics diagnosis of oncology, we are in an attractive space with a validated platform and biomarkers, plus a clear commercialization strategy,” Dr. Groen said following his address at the BIO CEO conference in New York last month.

He points out that there are four FDA-cleared epigenetic drugs already on the market, with more than 60 companies working on new epigenetic therapies. “This sector is booming as part of the promise of personalized medicine to select patients who are more or less likely to respond to particular drugs.” Studies suggest that the global market for epigenetics therapies and technologies will climb to more than $5-billion by 2023 from $2-billion this year.

Along with the two efficacy studies last month, MDxHealth released data from a peer-reviewed economic analysis of ConfirmMDx published in the Journal of American Health & Drug Benefits.

Among other things, the analysis demonstrated that a commercial health plan would realize cost savings within the first year of establishing coverage for the ConfirmMDx test for prostate cancer. The upfront cost would be recovered based on the savings associated with avoided biopsy procedures and associated complications.

Clinical Utility and Reimbursement

Clinical Utility and Reimbursement

Given these assumptions and the costs associated with the current standard of care, the inclusion of ConfirmMDx in the management of men screened for prostate cancer resulted in a net cost savings of $588 per patient or a budget impact savings of $500,000 in a managed care plan of one million members, according to the study.

“These numbers provide a strong economic incentive for the reimbursement of ConfirmMDx by commercial health plans,” said Petercam’s Mr. Verhelst.

Dr. Groen says MDxHealth is using epigenetic markers to develop diagnostic tests for cancer, with: ConfirmMDx products to assess the presence or absence of cancer; InformMDx products to distinguish between aggressive and non-aggressive cancers and to forecast the risk of recurrence; and PredictMDx products to decide which treatments are most likely to be effective.

“Our commercial partnerships demonstrate the value of our technology and biomarkers,” he adds. The company runs clinical trials for pharmaceutical companies, out-licenses its platform to pharma companies for their research only, develops diagnostics for pharma companies and has partnered with diagnostic companies in the U.S. for use of MDxHealth’s biomarkers.

Commercial Partnerships Demonstrate Value of MDx Technology and Biomarkers

Commercial Partnerships Demonstrate Value of MDx Technology and Biomarkers

The company operates a CLIA-approved lab in Irvine, Calif., and is awaiting a decision regarding its New York State license. It also has signed a co-marketing agreement with a commercial pathology lab, PlusDx, which has 25 sales reps in the field that target urologists for traditional pathology work. Dr. Groen says MDxHealth plans to expand the size of its own sales force to 15 from five this year and expand its marketing agreements in the U.S.

The company also will begin looking for commercialization opportunities to sell its prostate cancer test outside of the U.S. He says, “In the U.S., the business comes down to Medicare and commercial reimbursement, while in the rest of the world, reimbursement is tied to hospitals that are on government budgets.” Dr. Groen says the company has submitted a substantial dossier for Medicare reimbursement in the U.S. and expects to receive a decision in 2013.

In addition to its prostate cancer test, MDxHealth is also developing ConfirmMDx for lung cancer and InformMDx for lung, colon and prostate cancers. These collaborations currently involve GlaxoSmithKline, Roche and Celldex. MDxHealth also has diagnostic programs in development for esophageal and breast cancer, with partners who wish not to be identified.

Product Pipeline

Product Pipeline

In January 2012, MDxHealth’s licensing partner, Exact Sciences (NASDAQ:EXAS), submitted the second module of its premarket approval application to the FDA for its stool DNA colorectal cancer screening test, Cologuard, which includes an MDxHealth epigenetic biomarker together with MDxHealth’s methylation-specific PCR platform.

Last week, MDxHealth reported that revenue for 2012 rose 71% to more than $6-million (EUR 4.6-million). The company initiated billing to U.S. third party private insurance payors in the third quarter of 2012 for tests performed in 2012.

Projected MDx Revenue by Analyst

Projected MDx Revenue by Analyst

“We are poised to build on this strong momentum in 2013,” Dr. Groen says. “During the year, we achieved all of our key milestones in support of the commercialization of ConfirmMDx for prostate cancer, and moving forward, we will continue to execute on our licensed central lab strategy, increasing our market penetration in the urology community and driving the development and commercialization of new ClinicalMDx and PharmacoMDx products and services.”

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