• Sysmex Inostics launches two NGS-based liquid biopsy panels for cancer therapy drug development

    • September 30, 2019
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    Hamburg, Germany and Baltimore, Maryland, 2019.09.27 – Sysmex Inostics announces the availability of the SafeSEQ Breast Cancer and Head and Neck Cancer Panels along with the SafeSEQ Rapid Custom Development program for circulating tumor DNA (ctDNA) analysis. SafeSEQ is a next-generation sequencing (NGS)-based approach that delivers sensitivity comparable to the clinically validated OncoBEAM platform for rare mutant molecule detection, with sensitivity down to five mutant molecules amongst ten thousand wildtype copies, or 0.05% mutant allele frequency (MAF).

    The SafeSEQ Breast Cancer Panel tests for mutations affecting the PIK3CA, ESR1, TP53, ERBB2, AKT1 and KRAS genes in ER-positive, HER2-negative breast cancer samples. Alterations in these genes can guide an oncologist’s selection of appropriate therapy, clinical trial enrollment, or indicate mechanisms of therapy resistance. The SafeSEQ Breast cancer panel provides unparalleled highly sensitive detection of mutant ctDNA and is thus also well suited for disease monitoring in order to assess treatment response, minimal residual disease and molecular relapse.

    The SafeSEQ Head and Neck Cancer Panel tests for mutations in the genes PIK3CA, CDKN2A, HRAS and TP53. Although head and neck squamous cell carcinoma (HNSCC) affects approximately 600,000 globally, molecular testing is not routinely performed, and a number of molecular alterations in these genes are actively being pursued as therapeutic targets. A primary challenge in HNSCC is that many patients exhibit low levels of ctDNA with the vast majority having a MAF below 1%. Below this level, many liquid biopsy tests have demonstrated poor performance. Sysmex Inostics has demonstrated reliable, high-sensitivity detection well below this level with detection of as few as five mutant molecules in a background of ten thousand wildtype ones, or a MAF of 0.05%.

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