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FDA approves Epigenomics’ Epi proColon test

BioCenturyFDA approves Epigenomics’ Epi proColon test

http://www.biocentury.com/dailynews/company/2016-04-13/fda-approves-epigenomics-epi-procolon-test

Published on Wednesday, April 13, 2016

Epigenomics AG (Xetra:ECX) said FDA approved a PMA for its Epi proColon blood-based colorectal cancer (CRC) screening test. Epigenomics and Polymedco Inc. (Cortlandt Manor, N.Y.) will jointly market Epi proColon in the U.S.

Epigenomics spokesperson Peter Vogt said the partners expect to launch the test in the next few weeks, but did not disclose the list price.

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In November, Epigenomics appealed FDA’s request for additional data demonstrating that Epi proColon would increase compliance in patients with a history of non-compliance to recommended CRC screening programs. The request came in a response letter for Epigenomics’ PMA, the second it had received for Epi proColon.

Epi proColon detects methylated DNA of the septin 9 (SEPT9) gene in blood plasma by real-time PCR.

Epigenomics gained EUR 1.31 (25%) to EUR 6.58 on Wednesday.

Exact Sciences Corp. (NASDAQ:EXAS), which markets CRC screening test Cologuard, rose $0.34 to $7.46 on Wednesday. Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene.

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Epigenomics scores FDA approval for colorectal cancer screening test

FierceMedicalDeviceshttp://www.fiercemedicaldevices.com/story/dx-digest-epigenomics-wins-fda-approval-colorectal-cancer-test-nanostring-a/2016-04-13

Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Epigenomics won FDA approval for its colorectal cancer screening tool. Testing heavyweight Siemens also got a regulatory nod for its Graves’ disease (GD) test. Last but certainly not least, NanoString Technologies and HalioDx teamed up to develop immuno-oncology gene expression tests. Read on for the details. And as always, feel free to contact us with any comments or questions. — Emily Wasserman (email | Twitter)

Epigenomics scores FDA approval for colorectal cancer screening test

German and U.S.-based molecular diagnostics firm Epigenomics got FDA approval for its blood-based colorectal cancer screening test.
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Epigenomics’ Epi proColon uses a blood sample to see whether or not patients are at risk for developing the disease. The test provides an alternative to other colorectal cancer screening methods including colonoscopy and stool-based fecal immunochemical tests.

The FDA based its approval on three major clinical studies, which showed that Epigenomics’ test was safe and effective in screening for colorectal cancer. But regulators are also asking the company to run a post-approval study to show Epi proColon’s long-term benefit.

The Berlin and Germantown, MD-based firm will market Epi proColon in the U.S. under a joint agreement with its partner Polymedco, who specializes in noninvasive colorectal screening technology.

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FDA Approves Epigenomics’ Blood-Based Colorectal Cancer Screening Test

genomewebFDA Approves Epigenomics’ Blood-Based Colorectal Cancer Screening Test

https://www.genomeweb.com/molecular-diagnostics/fda-approves-epigenomics-blood-based-colorectal-cancer-screening-test

Apr 13, 2016

a GenomeWeb staff reporter

NEW YORK (GenomeWeb) – Epigenomics announced today that the US Food and Drug Administration has approved the company’s blood-based colorectal cancer screening test Epi proColon.

Epi proColon is a PCR-based test that detects methylated Septin9, a biomarker already incorporated into laboratory-based tests currently available in the US. It is now approved for use in average-risk patients who choose not to undergo screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests, and will be co-marketed by Epigenomics and strategic partner Polymedco.

The FDA approval comes after a series of setbacks for Epigenomics. Although Epi proColon received a positive recommendation from an FDA advisory panel in early 2014, the agency issued Epigenomics a “not approval letter” for the test a few months later.
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In its letter to Epigenomics, the FDA noted that the firm’s clinical studies of the Epi proColon were conducted in patients who had agreed to a routine screening colonoscopy, and asked for data demonstrating that the test would boost compliance to colorectal cancer screening in its intended population of patients who currently don’t undergo such screening.

Meanwhile, Exact Sciences’ stool-based colorectal screening test Cologuard got a nod from the advisory panel in 2014 and was approved by the FDA that August. The Centers for Medicare and Medicaid Services also issued a proposed national coverage determination for the test.

In July 2015, Epigenomics received some good news when China included the Epi proColon in its screening guidelines for colorectal cancer. However in late 2015, the FDA said it would require yet more data before making its own decision on the test. It was not until this January that the FDA told the company the additional information it had submitted was sufficient.

“We are excited by the FDA’s decision to approve Epi proColon as the first and only blood-based colorectal cancer screening test,” Epigenomics CEO and CFO Thomas Taapken said in a statement. “Given the significant benefits for patients, healthcare professionals, and payors, Epi proColon could help to meet the objective of 80 percent screening compliance of the eligible US population as pursued by US guideline bodies such as the American Cancer Society.”

Epigenomics said that it intends to conduct a post-approval study to demonstrate the long-term benefit of the test.