Caris Life Sciences Showcases Data Demonstrating the Clinical Value of Clonal Hematopoiesis Identification and Subtraction in Liquid Biopsy to Improve the Accuracy of Treatment Recommendations
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IRVING, Texas, Nov. 25, 2024 ~ A recent study presented at the International Society for Liquid Biopsy (ISLB) 6th Annual Congress has highlighted the importance of accurately identifying clonal hematopoiesis (CH) mutations in liquid biopsy profiling results. The study, conducted by Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, in collaboration with leading cancer centers, including those within the Caris Precision Oncology Alliance™ (Caris POA), demonstrated the clinical value of subtracting CH mutations from liquid biopsy results to avoid incorrect treatment recommendations.

According to George W. Sledge, Jr., MD, EVP and Chief Medical Officer of Caris, as we age, we accumulate somatic CH mutations in our blood that can lead to false positives in blood-based molecular profiling tests. This can complicate treatment decisions and potentially harm patients. Accurately determining which variants are coming directly from the tumor versus which are germline or CH is crucial for patient care.

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The study utilized Caris Assure™ assay, which uniquely and accurately identifies clonal hematopoiesis in a way not possible when sequencing plasma alone. The assay was used to analyze 11,914 patients with advanced cancer across 48 tumor types. The results showed that nearly four out of ten patients had at least one pathogenic or likely pathogenic CH variant among reportable clinical genes. This prevalence increased with age, ranging from 17% for patients aged 65-69 to 50% for those over 80 years.

The study also found high rates of CH mutations in DNA repair genes that are prescriptive for PARP inhibitors in cancers such as breast, female genital tract, ovarian, pancreatic, prostate, and endometrial cancer. For example, 79.9% of BRCA2 variants were found to be of CH origin, meaning that nearly eight out of every ten mutations detected were not from the tumor itself and, therefore, not relevant to therapeutic decision-making. Similar high rates were seen for other genes such as CHEK2 (79.4%), BRCA1 (68.5%), and ATM (41.9%).

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Caris Assure provides higher confidence for therapy selection by excluding CH mutations, compared to plasma-only biopsies. This is especially important for patients with cancer as it ensures that treatment decisions are based on accurate information.

David Spetzler, MS, PhD, MBA, President of Caris, stated that Caris Assure is the only commercially available blood-based profiling assay that accurately identifies clonal hematopoiesis mutations instead of using ineffective algorithmic approximations. This provides doctors and patients with more accurate treatment recommendations to fight their disease.

The study was performed in collaboration with members of the Caris POA, which includes 96 cancer centers, academic institutions, research consortia and healthcare systems. The alliance aims to advance precision oncology and biomarker-driven research by establishing and optimizing standards of care for molecular testing.

In conclusion, the study presented at ISLB highlights the importance of accurately identifying CH mutations in liquid biopsy results to avoid incorrect treatment recommendations. The use of Caris Assure assay provides higher confidence for therapy selection by excluding CH mutations and ensures that patients receive appropriate treatment based on accurate information.
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