Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today introduced its Caris Assure™ liquid biopsy assay at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Booth #22081).
“Caris Assure establishes a new standard for liquid biopsy testing,” said David D. Halbert, Chairman, Founder and CEO of Caris Life Sciences. “Current liquid biopsy offerings examine smaller panels of genes, which lack the versatility for the identification of novel predictive markers and signatures that are only possible through the whole exome and whole transcriptome approach unique to Caris. With Caris Assure, we have created the most extensive sequencing assay available to ensure we leave no stone unturned in properly guiding treatment selection and ongoing cancer care management.”
Caris Assure is a blood-based molecular profiling assay that uses a novel circulating nucleic acids sequencing (cNAS) approach to analyze the Whole Exome (cfDNA) and Whole Transcriptome (cfRNA) of 22,000 genes, including Loss of Heterozygosity (LOH), Microsatellite Instability (MSI) and Tumor Mutational Burden (TMB) from a simple blood sample. This unique assay includes characterization of somatic tumor alterations, somatic Clonal Hematopoiesis of Indeterminate Potential (CHIP) alterations and identification of incidental germline findings. The assay further enables minimally invasive serial monitoring for detection of tumor heterogeneity and emergence of resistance mutations.
“We have applied the same industry leading, multi-cancer profiling technology used in our tissue assay to blood,” said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris. “Our broad, 22,000 gene WES and WTS analysis ensures we render the most accurate results and findings for physicians seeking to properly diagnose, treat and monitor cancer patients. We are excited to bring this assay to the market and provide physicians with a new and comprehensive multi-cancer blood assay to add to their cancer diagnoses and treatment strategies.”
Caris Assure sequences the largest panel of genes across both cfDNA (Whole Exome) and cfRNA (Whole Transcriptome), which helps overcome many of the shedding problems that plague cfDNA-only assays. By including DNA and RNA coverage across somatic tumor, somatic CHIP and germline alterations, Caris Assure captures more tumor-informed material, leading to improved performance and comprehensive molecular profiling results for the physician and patient. The approach also results in fewer missed mutations due to more tumor derived material inputs and concordance to tissue, as well as fewer false positives due to the analysis of CHIP mutations.
In an initial performance validation study of this first-of-its-kind whole exome, whole transcriptome (22,000 gene) blood assay, Caris Assure demonstrated more than 95 percent sensitivity for variant frequencies greater than 0.5 percent, while maintaining greater than 99.99 percent specificity. Additional validation data will be released in the coming months.
Caris Assure will be commercially available in the second half of calendar year 2022, with limited availability in the third quarter and expanding availability in Q4 and 2023.
