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Caris Assure™

"Caris Life Sciences®...announced a landmark study published in Scientific Reports, a Nature journal, demonstrating the accuracy and clinical utility of the Caris Assure® blood-based biopsy assay across the cancer continuum."

For MRD and recurrence monitoring, the disease-free survival of patients whose cancers were predicted to have an event was significantly shorter than those predicted not to have an event using a tumor naïve approach (HR = 33.4, p < 0.005, HR = 4.39, p = 0.008, respectively). The data presented here demonstrate a unified liquid biopsy platform that uses blood-based whole-exome and transcriptome sequencing coupled with artificial intelligence to address the important clinical needs in multi-cancer early detection, monitoring of MRD and recurrent cancers, and precision selection of molecularly targeted therapies.

"Caris Life Sciences® (Caris)...today announced the publication of "Characterization of plasma cell-free DNA variants as of tumor- or clonal hematopoiesis-origin in 16,812 advanced cancer patients," in Clinical Cancer Research. Utilizing Caris Assure™ blood-based profiling, the study shows how CH-associated variants, which are highly prevalent in cancer patients, can often overlap with therapeutic targets. The findings underscore the importance of distinguishing CH- from tumor-derived mutations to improve diagnostic accuracy and guide appropriate cancer therapy."

This large study highlights the need for thorough CH classification during liquid biopsy to appropriately recommend therapies, especially PARP inhibitors.

"Caris Life Sciences®...today announced the presentation of data highlighting the clinical value of subtracting clonal hematopoiesis (CH) mutations from liquid biopsy profiling results to avoid incorrect treatment recommendations. Caris generated the findings, in collaboration with leading cancer centers, including those within the Caris Precision Oncology Alliance™ (Caris POA), and presented the data on November 23, 2024, at the International Society for Liquid Biopsy (ISLB) 6th Annual Congress. The study’s results demonstrate the power of the Caris Assure™ assay to identify somatic tumor, incidental CH and incidental germline variants by sequencing both the plasma and buffy coat in a single whole exome and whole transcriptome next-generation sequencing assay."

These preliminary results suggest that CSF liquid biopsy may be useful for identifying mutations in primary and metastatic brain tumors. Serial sampling is feasible, and may disclose changes in diagnostic and/or driver mutations over time, with important therapeutic and diagnostic implications. Many mutations were found in CSF alone.

These preliminary results suggest that CSF liquid biopsy may be useful for identifying mutations in primary and metastatic brain tumors. Serial sampling is feasible, and may disclose changes in diagnostic and/or driver mutations over time, with important therapeutic and diagnostic implications. Many mutations were found in CSF alone.

Jaclyn Hechtman will explore the utility of whole blood biopsy for profiling solid tumors, with a focus on the critical distinction between clonal hematopoiesis (CH) and tumor-derived mutations. By analyzing both plasma and Buffy coat, Caris Assure enables clinicians to more accurately identify tumor alterations, ensuring precise diagnosis and targeted treatment to improve patient outcomes.

"Caris Life Sciences® (Caris)...announced that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present 10 studies across eight tumor types at the 2024 American Association for Cancer Research (AACR) Annual Meeting on April 5-10, 2024, in San Diego, CA, at Booth Number 1105."

"Lastly, for therapy selection, detection of driver mutations where blood was collected within 30 days of matched tissue demonstrated high concordance with a PPA of 93.8% and PPV of 96.8%. CHIP correction proved to be essential as ~35% percent of patients had CHIP mutations, including KRAS, BRAF, ATM, BRCA1/2, findings that could lead to improper therapy selection.Herein, we demonstrate for the first time a single liquid biopsy assay that addresses the entire continuum of care in clinical oncology with optimal diagnostic, prognostic, and predictive utility for patients and physicians."

The novel Caris Assure liquid biopsy platform demonstrates high sensitivity and specificity for somatic variants, while mitigating against FPs from CH, and identifying incidental germline pathogenic alterations.

Furthermore, through translational research, our trial will shed light on which patients would benefit from the targeted combination therapy for patients with HRR gene-mutated tumor even after the failure of ICIs. The IMAGENE trial: jRCT, Clinical trial no.: jRCT2051210120, Registered date: November 9, 2021.