http://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.