Colorectal cancer test kit Plasma-SeqSensei™

geneticEGFREpidermal Growth Factor

highly sensitive down to 0.07% mutant allele fractions fast turnaround time of two days from cfDNA to report convenient data analysis and reporting with IVD-certified software Sensitive mutation detection and streamlined workflow Plasma-SeqSensei™ assays enable highly sensitive and quantitative detection of mutations in circulating tumour DNA (ctDNA) from the blood plasma of cancer patients by utilising next-generation sequencing technology. Plasma-SeqSensei’s™ short and standardised workflow delivers results within two days, including the generation of easy-to-read reports using laptop-compatible Plasma-SeqSensei™ IVD Software. The kit covers key gene mutations on BRAF, EGFR, KRAS, NRAS and PIK3CA to detect established and emerging predictive markers, resistance mutations and frequently occurring genetic alterations in cancer. Plasma-SeqSensei™ Solid Cancer IVD Kit is intended to support clinicians with: detecting minimal residual disease recurrence surveillance (neo-)adjuvant response monitoring analysing the RAS mutation status to determine the potential benefit of anti-epidermal growth factor receptor (EGFR) therapy for colorectal cancer patients Technical specifications Sample capacity - 2–16 samples per kit QC function - Positive control and no template control (NTC) applied to every run Compatible platforms - Illumina NextSeq 500/550™ Number of amplicons - 17 Analytical sensitivity - Cut-off: 0.07% allele frequency on a background of 10,000 GE represent the assay´s cutoff of 7 mutant molecules (MM). LOD: 0.09-1.55% allele frequency, based on 20.34 MM across a validated range of 1,315-22,500 GE