Genomictree has released the results of an interim analysis of a clinical trial of Earlytect, its colon cancer diagnostic kit, for evaluating the device’s sensitivity and specificity.
The trial, conducted by the Korean Society of Coloproctology (KSC), was based on the feces of patients at a high risk of developing colon cancer and subject to undergo colonoscopy in seven university hospitals in Korea from April 2020. Participants in the high-risk group for colorectal cancer were those aged 40 years or older with a family history of cancer, experienced polypectomy or inflammatory bowel disease, and had a family history of hereditary polyposis and nasal polyposis colorectal cancer.
After randomly using the Earlytect diagnostic device on participants, the team compared the device’s detection power between cancer patients, ordinary people, and patients with polyps and compared them with colonoscopy results.
“As a result of conducting an intermediate analysis with Earlytect, the sensitivity for diagnosing colorectal cancer was found to be 100 percent regardless of the stage or location of the tumor as well as gender or age of the study subject,” the company said. “When there was no disease, the specificity for clearing the patient was 90 percent.”
Genomictree plans to release the final analysis results of this study, covering about 1,200 cases, in the first quarter of next year.
The company expects that if the clinical usefulness of the final results is confirmed, it will secure the clinical evidence for using the Earlytect diagnostic kit as a screening method for high-risk colon cancer.
“The five-year survival rate reaches about 94 percent when colon cancer is detected early, but the early detection rate of colon cancer in Korea is low at 37.7 percent,” said Professor Lee Seok-hwan, president of KSC and lead investigator. “As a result, most colon cancer patients are found at later stages, which also explains why colon cancer has the third-largest cancer mortality rate in Korea.”
Particularly, for those over 60 years of age, family history, genetic history, polyp resection history, or high-risk group with inflammatory bowel disease, regular colon cancer screening plays a vital role in reducing mortality, he added.
“If the clinical effectiveness of an in vitro molecular diagnostic test using fecal DNA biomarkers is confirmed, we expect that it will be of great help in early detection of colorectal cancer in high-risk groups,” he said.
Genomictree CEO An Sung-whan also said, “To confirm the clinical excellence of Earlytect and the effectiveness of colorectal cancer diagnosis in the actual clinical field, the company will secure various clinical evidence for high-risk groups and real-world studies.”
Looking at the interim clinical results confirmed so far, the company expects that Earlytect’s diagnostic accuracy has been proved once again in the final results of analyzing 1,200 cases, he added.