Novel Blood Test Detects Precancerous Colorectal Adenomas

A novel blood test has shown promise for colorectal cancer screening.

The "multiomics" test, under development by Freenome, has previously been shown to detect early-stage (I/II) colorectal cancer with a sensitivity of 94% and a specificity of 94%.

A new study shows that it can also detect precancerous lesions, colorectal advanced adenomas (AAs).

"The ability to detect advanced adenomas is incredibly important because we can remove them before they become cancerous," said senior author Aasma Shaukat, MD, MPH, chief of gastroenterology at Minneapolis VA Health Care System and professor of medicine, the University of Minnesota Medical School, Minneapolis, Minnesota, in a statement.

At the Gastrointestinal Cancers Symposium (GICS) 2021, she presented data showing that the novel test was able to detect AAs with a sensitivity of 41% and a specificity of 90%.

This sensitivity of the new test is better than or similar to that of currently available stool tests, noted study author C. Jimmy Lin, MD, PhD, MHS, chief scientific officer at Freenome.

The new test had almost double the sensitivity for detecting AAs (41% vs 24%) as the fecal immunochemical test (FIT), and its sensitivity was comparable to that of FIT-DNA testing (41% vs 42%).

In addition, it showed much higher sensitivity (41% vs 22%) for detecting AAs than the Epi proColon, a screening blood test that has been approved by the US Food and Drug Administration (FDA) for detecting methylated septin 9 DNA (mSEPT9).

"What's special about our company is...that we use a multinomic technology, meaning we look at DNA, RNA, protein, and other biomarkers — all of these things together," Lin told Medscape Medical News.

Their platform integrates assays for circulating free DNA, methylation, and proteins using advanced computational biology and machine-learning techniques, which provide a multidimensional view of both tumor- and immune-derived signatures that enable the early detection of cancer.

In contrast to other blood tests that are under development for cancer screening, some of which claim to detect several common cancer types, Freenome is focusing only on colorectal cancer. "There are other companies in the early detection space, but some of them are doing multicancer screening and have a generalized product," said Lin. "Our approach is to focus on a specific cancer type, and we are beginning with colorectal cancer screening, and then will expand to other types."

Better Sensitivity

The study that was presented at the meeting evaluated the novel multiomics blood test for AA detection.

Blood samples were obtained from participants in the AI-EMERGE study, a prospectively collected multicenter study that included primarily average-risk screening patients from 30 clinical sites in the United States and Canada. The study included a total of 542 samples, including 122 histopathologically confirmed AAs and 420 colonoscopy-confirmed negative control samples.

AA sensitivity of the novel test was greater than that with the mSEPT9 test, which is the only blood test currently available for colorectal cancer screening. The new test's sensitivity was much higher than that of FIT and was comparable to that of FIT-DNA. Sensitivity increased with increasing lesion size and was consistent across location and histology except for serrated lesions, the authors noted in the abstract.

"By combining signatures from both tumor and nontumor-derived sources, our multiomics signatures detect twice as many AAs as methylation only or single-protein approaches," Lin said. "And we have now shown that sensitive AA detection at a level similar to or better than currently available stool test is achievable in blood, which is necessary for effective early detection and prevention of colorectal cancers."

The company has begun the regulatory process for having the test approved by the FDA. The company's goal is to enroll 14,000 participants and have prospectively collected data.

The research was funded by Freenome. Lin is the chief scientific officer at Freenome and has relationships with Labroots, Natera, and Neon Therapeutics. Shaukat has relationships with Freenome and Iterative Scopes

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