NEW YORK – Cancer molecular diagnostics firm Epigenomics announced on Wednesday a restructuring that will include the recall of its Epi proColon blood-based colorectal cancer test, staff cuts, and the reduction of its remaining operations.
The firm, which has offices in Berlin and San Diego, said it will keep only enough employees at both sites to maintain minimal business operations, but it did not provide details on how many employees would be laid off or retained. On deadline, Epigenomics did not respond to a request for additional comment.
The company is also halting sales of the Epi proColon cancer test, which it previously said it would no longer market after the US Centers for Medicare and Medicaid Services denied coverage in 2021.
The company is also cutting its supervisory board from five members to three, applying for revocation of its admission to the Prime Standard subsegment of the Frankfurt Stock Exchange, and ending its American Depositary Receipts program. Epigenomics plans to publish on April 21 an annual report with financial statements for fiscal year 2022.
The firm said it predicts 2023 revenues in the range of €60,000 to €200,000 ($64,000 to $256,000).
Epigenomics CEO Greg Hamilton said in a statement that the company had been unable to secure funding for a pivotal study needed to support submission of the company's next-generation colorectal cancer screening test for US Food and Drug Administration approval, and the restructuring is a "tough but, in our view, unavoidable step to ensure the continued existence of the company."
He said company leaders remain convinced of the test's value and hope to find a path toward further development and regulatory approval. The firm said in December that in preclinical testing involving 241 individuals ages 45-85 years, its next-generation colorectal cancer detection assay had achieved 84 percent sensitivity and 90 percent specificity with an advanced adenoma detection rate of 20 percent.
The firm said at the time that if the company could achieve similar results in its prospective clinical trial CRC-DRAW, it would exceed US CMS criteria of 74 percent sensitivity and 90 percent specificity for Medicare reimbursement.
The firm also said in December it expected to post a loss for fiscal year 2022 of €10.2 million to €10.8 million before interest, taxes, depreciation, and amortization.