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Epigenomics to Meet with FDA, Hire US Head as it Looks to Crack US Market

By Tony Fong

NEW YORK (GenomeWeb News) – As Epigenomics prepares to enter the US market, it plans to meet with the US Food and Drug Administration in the coming weeks and to hire someone to direct its commercial operations in the US.

On the sidelines of the JP Morgan Healthcare Conference last week in San Francisco, an official from the German molecular diagnostics firm outlined the company's plan to break into the US market with its lead product, the Epi proColon test for the early detection of colon cancer.

As Epigenomics eyes the US market, Achim Plum, senior vice president of corporate development, told GenomeWeb Daily News that the company is also looking for a successor to Oliver Schact, chief financial officer and CEO for the company's Seattle-based US subsidiary. The company disclosed last week that Schact would be leaving the firm and that Thomas Taapken would replace him as CFO.

The title of the new hire has not yet been decided, Plum said, but the person will head the company's efforts to establish a commercial infrastructure in the US. That would include developing a strategy to get Epi proColon into physician offices and clinics, getting them to prescribe the test, and creating "a pool [of patients] through patient advocacy groups and awareness," Plum said.

He said that officials conducted a "couple" of interviews during last week's conference and that he expects the firm to hire someone during the current quarter.

At the moment, the Seattle facility conducts only clinical research because Epigenomics does not have an FDA-cleared product commercially available in the US, though Quest Laboratories and ARUP Laboratories both market Epi proColon as a laboratory-developed test.

The idea is that upon FDA clearance, the laboratories that offer it as a CLIA test would start offering it as an FDA-cleared test. "We want to make sure that the product with the highest regulatory clearance level is used in the marketplace," Plum said.

The Epi proColon test, which is based on the company's Septin 9 DNA methylation biomarker, was launched in October 2009. The CE-marked test is currently available in parts of Europe and the Middle East.

Epigenomics is adapting the test for FDA clearance, meaning it must be put on a platform that is already FDA cleared. "We are simplifying the workflow, streamlining it … switching it to GMP-grade reagents, for example," according to Plum.

In Europe the test runs on the Roche LightCycler 480 PCR system and the ABI 7500 PCR system. Epigenomics has secured access to an "open system" in the US, which has been cleared by the FDA for other assays, though Plum declined to identify the vendor.

In addition, Epigenomics is scheduled to have a pre-investigational device exemption meeting with the FDA in early February. Two months ago, the company submitted a pre-IDE briefing booklet to the agency, outlining its plan for the test in the US, its clinical claims, and its validation strategy.

During the February meeting, FDA will provide feedback on Epigenomics' approach. Based on that meeting, if Epigenomics is comfortable that its assay design will pass FDA scrutiny, it can go into initial manufacturing for the first lots and then proceed to clinical validation.

The plan is to submit to FDA before the end of 2011 for a US launch of Epi proColon in the second half of 2012, Plum said.

Abbott, which holds a license to the Septin9 biomarker that gives it marketing rights in Europe and Asia-Pacific, is separately seeking FDA approval of the test on its m2000 system. Abbott sells the test as a kit in Europe as the mS9 assay.

Building from Scratch

Epigenomics' US facility currently has a staff of about 14, but once it begins setting up its commercial operations, it will add a sales staff and technical support staff. For all intents and purposes, the Seattle subsidiary has no commercial operations, "so the person we hire will have to build that from scratch," Plum said.

Plum declined to disclose any revenue figures for Epi proColon, but said that the US market is clearly an important one if the test is to become truly successful.

The goal for Epi proColon, which would be marketed as a kit if cleared by FDA, is not to replace colonoscopies, which remain the gold standard for detecting colorectal cancer, but rather to identify high-risk patients who should receive regular screening.

According to Plum, about half of the US population, or 45 million people, should be screened for colorectal cancer, either by colonoscopies or fecal occult blood tests, but don't for a variety of reasons, including inconvenience, discomfort from such screens, or the "yuck factor."

"The idea is really to encourage the people who don't anything at the moment to get a colonoscopy," he said. If a patient tests positive on the Epi proColon, the next step would be to get a colonoscopy. "Those people who are prepared [to get] a colonoscopy are really not our target group," he added.

If Epigenomics is successful in its efforts, it would join a growing number of companies eyeing the US colon cancer market. Exact Sciences, for example, is preparing a prospective trial in preparation of an FDA submission for its Cologuard DNA screen. In addition, Agendia told GWDN last week it plans to file with the FDA for clearance of its ColoPrint test for stage II and III colon cancer prognosis and prediction, and Genomic Health recently completed a validation trial for its Oncotype DX colon cancer test.

Aside from sheer market size, the US has other factors that make it attractive, including the ability to do direct-to-consumer marketing once FDA clearance is gained, something not possible in other countries such as Germany, Plum said. Also, because the US insurance market remains one in which private insurers continue to be a major player, economics plays a bigger role in healthcare decisions.

In considering whether a test should be reimbursed, private insurers factor in whether the test has any long-term healthcare economic benefits, and if a test can provide benefits by preventing disease, Plum said.

In government-run reimbursement systems, however, longer-term economic benefits are often overlooked in place of immediate cost impacts, he said. In Germany, for instance, "If you then tell them you have a test and it costs a certain amount of money, but it will save you money six years down the road, for them it's not an immediately compelling story," according to Plum.

Last year, Epigenomics presented data from a prospective study called the Presept Study in which the Epi proColon test was able to detect 67 percent of colorectal cancer cases at a specificity of 88 percent when compared to colonoscopies.

The study has been submitted to a scientific journal for publication, and in conjunction with that, the company plans to publish data from a healthcare economic analysis that will outline the healthcare savings that can be achieved with Epi proColon.

Along with early detection of colon cancer, Epigenomics is evaluating the use of the Septin 9 biomarker for other settings around colon cancer, including its use as a prognostic marker, and especially the effectiveness of Septin 9 as a monitor to determine whether colon cancer patients will relapse, Plum said.

"If you look at relapse monitoring of cancer, it's a tricky business," he said. "We have very bad markers for that."

Along with its colon cancer test, Epigenomics markets the Epi proLung test in Europe for confirming the diagnosis of lung cancer when imaging or cytology tests are inconclusive. There are no plans yet to launch it in the US, Plum said.

The company also is developing a biomarker for prostate cancer, Pitx2, that may be useful in stratifying patients who have a high likelihood of relapse after prostatectomy. Epigenomics has been able to measure the biomarker in tissue biopsies but has not done validation studies on clinical samples. The company is searching for a partner that is active in the prostate cancer arena to develop an assay around the biomarker.

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