A collaborative study led by researchers from Mass General Brigham, the Wyss Institute at Harvard University, and Dana-Farber Cancer Institute, alongside international partners, has developed an ultra-sensitive, low-cost blood test, which shows promising results for early cancer detection and monitoring by pinpointing minute levels of a specific cancer biomarker.
Highlighting the Innovative Test
The test utilizes just half a drop of blood (25 microliters) and employs a single-molecule-based detection technology named SIMOA, developed by the Walt lab.
It targets the open reading frame 1 protein (ORF1p), a transposable element protein prevalent in various cancers but absent in normal tissues, acting as an indicator of a high risk of cancer lethality.
The test has already demonstrated efficacy in detecting ORF1p across numerous cancer types and showcased the potential as a reliable pan-cancer biomarker.
Probing into the Research Details
The initial pilot experiment and subsequent iterations with engineering enhancements were more successful than anticipated, revealing the remarkable ability of this test to detect biomarker expression across different cancer types.
“We were shocked by how well this test worked,” remarked lead author Martin Taylor, M.D., Ph.D., from the Department of Pathology at Massachusetts General Hospital.
Collaborating with a myriad of institutions, the researchers validated the tool using blood samples from patients with various cancers, including ovarian and colorectal cancer.
ORF1p was quantified in cancer patient blood samples, affirming its specificity for cancer detection, with the protein expression prevalent in carcinomas and high-risk precursor lesions in tissue samples.
ORF1p: A Potential Hallmark of Cancer
“Our results bolster the emerging idea that ORF1p expression is a ‘hallmark of cancer’ expressed starting early in the disease process,” Taylor said.
The lack of expression in normal tissues and pervasive expression in carcinomas renders ORF1p distinctly specific and not akin to other protein biomarkers, which might possess normal expression levels.
Caveats and Future Directions
Despite its specificity, the test does not divulge extensive information, such as the location of cancerous tissues in the body. Moreover, it does not identify all cancers and their subtypes.
Hence, the tool is visualized to be utilized conjointly with other tests to enhance early detection testing methodologies and enable real-time monitoring of patient responses to cancer therapies.
David Walt, Ph.D., of Brigham and Women’s Hospital and a core faculty member at the Wyss Institute, acknowledged, “The test is very specific, but it doesn’t tell us enough information to be used in a vacuum.”
While the early success of this ultrasensitive assessment tool is exciting, Walt recognizes that further investigation is necessary.
Propelling Forward into Larger Clinical Trials
Researchers are now exploring the test’s accuracy in larger trial cohorts and various patient populations.
They are striving to decipher whether the assessment of the ORF1p biomarker would be beneficial in patient care and are also probing whether the biomarker can be utilized to stratify cancer risk in patients.
Co-corresponding author Kathleen Burns, M.D., Ph.D., Chair of the Department of Pathology at Dana-Farber, reflected on the potential impact, “Having a technology capable of detecting ORF1p in blood opens so many possibilities for clinical applications.”
The team, energized by the compelling results, continues to explore the exciting horizons that this technology opens up in the domain of early cancer detection and management.
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The research findings can be found in Cancer Discovery.
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