FDA has granted premarket approval for the Epi ProColon screening test by Epigenomics AG, Berlin, Germany. The blood-based colorectal cancer screening test is an in vitro polymerase chain reaction assay for the qualitative detection of Septin9 gene methylation in DNA isolated from the patient’s plasma.
“This is the first FDA-approved circulating tumor DNA assay, so it really is a breakthrough,” says Noel Doheny, CEO of the company’s US subsidiary, Epigenomics Inc, Germantown, Md. “This is the first time we have been able to go all the way to blood with a circulating tumor marker, and it represents a dramatic move toward liquid biopsy,” he adds. “This is really a pioneer product.”
Cytosine residues of the Septin9 gene are methylated in colorectal cancer tissue but not in normal colon mucosa. This tumor-specific methylation pattern can be used to detect cell-free DNA shed into the bloodstream by tumor cells. Detection of colorectal cancer-derived DNA in blood plasma using the Septin9 methylation biomarker has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer.
According to Doheny, Epigenomics will not offer testing services itself, but will seek “to make US diagnostic laboratories a vital element in colorectal cancer screening.” The test will be made available in the United States under a joint commercialization agreement with the company’s long-time partner Polymedco, Cortland Manor, NY. It is currently marketed in Europe, China, and select other countries.
“We are excited by FDA’s decision to approve Epi ProColon as the first and only blood-based colorectal cancer screening test,” says Thomas Taapken, PhD, CEO and CFO of Epigenomics AG. “While colorectal cancer remains the second-leading cause of cancer death in the United States, one out of three eligible Americans still does not undergo colorectal cancer screening. Given the significant benefits for patients, healthcare professionals, and payors, Epi ProColon could help to meet the objective of 80% screening compliance of the eligible US population as pursued by US guideline bodies such as the American Cancer Society.”
The availability of a blood test opens a new category apart from invasive methods such as colonoscopies and stool testing methods, Taapken says. “A blood-based test poses a much lower barrier for patients who have so far not been complying with existing methods to participate in colorectal cancer screening,” he adds.
“Epi ProColon has the potential to become an important opportunity for laboratories across the country to join the fight on colorectal cancer,” says Drew Cervasio, president and CEO of Polymedco. “We are very much looking forward to bringing this new, highly innovative blood-based test to the US market.”
The test is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests.
For patients, the test only requires a simple blood sample to be drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a local or regional diagnostic laboratory.
Epi ProColon has received FDA approval based on demonstrations of safety and efficacy as established in three major clinical studies. The test has also demonstrated its potential to significantly increase participation rates in colorectal cancer screening.
As typically required by FDA for new screening products, the company will initiate a postmarket study to determine the test’s long-term benefit. “We have 6 months to negotiate the final details of the study design with FDA,” Taapken says. “We will also use that time to select the centers that will be conducting the study, and to settle the study parameters. The study itself will probably start toward the end of this year.”
According to the American Cancer Society, there are projected to be more than 134,000 new diagnosed cases of colorectal cancer and almost 50,000 deaths from colorectal cancer in 2016 in the United States, where it remains the second-leading cause of cancer death.
For more information, visit Epigenomics.