Biomarkers play a pivotal role in guiding cancer care, serving as vital indicators of cancer risk and aiding in treatment decisions. Drs. Brendan Sheffield, Andrea Beharry and Shaan Dudani of the Osler Research Institute for Health Innovation, along with a team of researchers from across Canada, have introduced a groundbreaking end-to-end proficiency testing exercise that improves on the traditional quality assessments of biomarker results.
Typically, researchers and clinicians use colon cancer tumor specimens to assess the accuracy of biomarker tests. However, the team sought a more holistic approach beyond only accuracy. They proposed including an assessment of turnaround times for results, specimen handling methods, and assessing the communication of results to oncologists and care teams.
To determine how these additional factors impact the quality of biomarker results, eight laboratories were tasked with analyzing tissue samples alongside a fictional medical scenario simulating a real-world diagnostic challenge. The test results were then evaluated by a team, including medical oncologists, who suggested treatment plans based on each lab's report. The results varied significantly: Three labs led to inappropriate treatments, with one treatment needing to be stopped altogether.
Published recently in the Journal of Molecular Pathology, the article described the disparity in lab results. Turnaround times ranged from six to 86 days, specimens were handled differently, and the reporting methods varied among labs. All these factors significantly impacted treatment decisions.
The multifaceted nature of biomarker results underscores the need for a different approach to quality measures, ultimately leading to better treatment decisions for cancer patients. “This new style of proficiency testing can really highlight where precision medicine is working well and where it's not,” said Dr. Sheffield. “These differences in lab practice can lead to big treatment discrepancies in cancer patients.”
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