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| Epigenomics CEO Thomas Taapken |
Epigenomics won marketing approval in China for its next-generation colorectal cancer test, moving the company forward on its path toward global commercialization for the product and helping it compete in an increasingly competitive playing field.
The company, along with partner BioChain, scored a regulatory signoff from the China Food and Drug Administration for its Epi proColon test, a noninvasive diagnostic that screens for colorectal cancer by looking at a Septin9 DNA methylation marker in the bloodstream. Regulators based their decision on a major clinical study completed in April 2014, which showed that Epi proColon detected 75% of all cancer cases at 97.5% specificity. Epigenomics touts its test as being able to screen for colorectal cancer earlier, cutting down on later stage disease and reducing healthcare costs.
Epigenomics and BioChain plan to launch the product in Chinese markets in the next few weeks, the companies said in a statement.
"We are extremely pleased to announced the approval of Epi proColon in the important Chinese market," Dr. Thomas Taapken, CEO and CFO of Epigenomics, said in a statement. "We are convinced that our test will help to reduce the mortality and costs of care associated with [colorectal cancer] in China through the early identification of the disease."
The news bodes well for Epigenomics, as it pushes for FDA approval for its blood-based colorectal cancer test. In March, the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 5-to-4 with one abstention that its Epi proColon test's benefits outweighed any risks, moving it one step closer to premarket approval. The company's PMA submission included data from a clinical trial of the 2.0 version of its test with nearly 8,000 samples, which showed that Epi proColon produced 68% sensitivity and 80% specificity but generated a 20% false-positive rate.
In June, the FDA turned down the company's PMA application for its colorectal cancer screening test, saying in a letter that it did not have sufficient evidence to warrant the product's approval. The company has since completed the design of a new study, which it hopes will show an increase in participation of patients in colorectal cancer screening when offered its Epi proColon test, as opposed to traditional screening methods.
Marketing approval in China also helps Epigenomics compete with other diagnostic outfits developing innovative colorectal cancer tests. Companies like Exact Sciences ($EXAS) and Belgium's VolitionRx are hard at work on related products, chalking up regulatory approvals and scoring critical reimbursement for their tests. In August, Madison, WI-based Exact won FDA approval and proposed CMS coverage for its stool-based colorectal cancer screening test through a joint pilot program from the FDA and the Centers for Medicare and Medicaid Services. In September, VolitionRx raised just over $1.1 million to fuel R&D for its noninvasive colorectal cancer diagnostic test panel. The company plans to pursue a CE mark application by the end of this year or in early 2015.
- read Epigenomics' statement