The recently published US Preventative Services Task Force (USPSTF) updated recommendation statement on colorectal cancer screening referenced multiple available options for colorectal screening, including Epigenomics’ Epi proColon. However, in a letter in JAMA, two researchers said that USPSTF did not take into account the most recent data available on this blood test when cautioning about its relatively low efficacy.
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The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing to age 75 years. In their statement, the group said that Epi proColon—a blood-based methylated SEPT9 DNA assay approved by the US Food and Drug Administration (FDA)—demonstrated a low sensitivity of 48% for detecting the disease in a test characterization study.
In their letter, Klaus Mergener, MD, PhD, Digestive Health Sciences (Tacoma, WA), and Nicholas T Potter, PhD, Molecular Pathology Laboratory Network (Maryville, TN), stated that the SEPT9 DNA data cited by the USPSTF was based on an earlier version of the assay and not the one approved by the FDA.
According to Drs Mergener and Potter, data from the Prospective Evaluation of Septin 9 Performance for Colorectal Screening trial showed that the approved test had a sensitivity of 68% and a specificity of 80%, while a second study demonstrated the test to have a sensitivity of 72% and specificity of 81% compared with 68% and 97%, respectively, for a fecal immunochemical test.
Both researchers who have received financial support for their research from Epigenomics said, “Ultimately, effective colorectal cancer screening will depend on participation as well as on the performance characteristics of the test used. Therefore, clinicians and patients should have the most recent data to make an informed decision about which screening modality to recommend and pursue.”
Greg Hamilton, chief executive officer of Epigenomics AG, said the company was pleased by JAMA’s decision to publish this important clarification on the clinical evidence.
