Skip to main content
Premium Trial:

Request an Annual Quote

Epigenomics Q3 Revenues Grow 7 Percent as Firm Awaits Regulatory Decisions on Colorectal Cancer Test

NEW YORK (GenomeWeb) – Epigenomics today said that its third quarter revenues grew 7 percent year over year as the firm progresses in its efforts to gain regulatory approval of its colorectal cancer molecular diagnostic test.

For the three months ended Sept. 30, the firm recorded revenues of €284,000 ($353,000), up from €263,000 in the year-ago quarter.

Epigenomics' net loss for the quarter was €1.8 million, or €.14 per share, compared to a net loss of €1.9 million, or €.16 per share, in Q3 2013. Its R&D costs were flat at €1.1million, while its SG&A costs also were unchanged at €1.1 million.

The company finished the quarter with €3.1 million in cash and cash equivalents, but it subsequently raised $5.3 million through the sale of shares to clinical diagnostics firm BioChain Institute, a marketing partner of the firm.

Epigenomics is currently seeking US Food and Drug Administration and Chinese Food and Drug Administration approval of its Epi proColon test. In June the FDA said the test was not approvable, and as part of its efforts to change the FDA's mind, the company completed the design of a study to demonstrate that the test will increase patient participation in colorectal cancer screening.

Epigenomics said today that initiation of the clinical and laboratory testing sites is underway. The company plans to conduct the study with two major US healthcare systems that actively manage colorectal cancer screening programs, and enrollment for the trial is anticipated to be completed in a few months.

"Epigenomics is convinced that generating the additional data requested by the [FDA] can be done quickly and that the approval of the test remains very likely," it said in a statement.

At the same time, Epigenomics and its partner BioChain are working for CFDA approval in China, which the company said is expected "in the foreseeable future."

"[W]e are now ready to embark on the final steps of the approval and commercialization of our test in the US and China," Epigenomics CEO and CFO Thomas Taapken said. "We have also secured the financial resources necessary for the execution of this important next phase in our development."

The Scan

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.

Sequencing Study Leads to Vaccine Target in Bacteria Behind Neonatal Meningitis

Researchers eBioMedicine track down potential vaccine targets with transposon sequencing on mutant bacteria causing neonatal meningitis in mouse models of the disease.

Multiple Myeloma Progression Influenced by Immune Microenvironment Expression

Researchers in NPJ Genomic Medicine compare RNA sequencing profiles of 102,207 individual cells in bone marrow samples from 18 individuals with rapid or non-progressing multiple myeloma.

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.