Plasma-SeqSensei™ Solid Cancer IVD Kit
Discover the benefits of our Solid Cancer IVD Kit
- 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
Gene targets
| Gene | Transcript1 | Amino acid start | Amino acid end | Most frequent mutations detected2 |
| BRAF | ENST00000288602.6 | 462 | 477 | G469A/R/V/E, G466V/E |
| BRAF | ENST00000288602.6 | 582 | 604 | V600E/K/R/M, K601E, D594G |
| EGFR | ENST00000275493.2 | 706 | 725 | G719A/S |
| EGFR | ENST00000275493.2 | 743 | 759 | E746_A750del, L747_P753delinsS, L747_T751del, L747_A750delinsP, E746_S752delinsV |
| EGFR | ENST00000275493.2 | 762 | 775 | S768I |
| EGFR | ENST00000275493.2 | 788 | 801 | T790M |
| EGFR | ENST00000275493.2 | 856 | 873 | L858R, L861Q |
| KRAS | ENST00000256078.4 | 12 | 34 | G12D/V/C/A/S/R/F, G13D/C/R/V/A |
| KRAS | ENST00000256078.4 | 57 | 76 | Q61H/R/L/H/K, A59T |
| KRAS | ENST00000256078.4 | 110 | 117 | K117N |
| KRAS | ENST00000256078.4 | 141 | 148 | A146T/V |
| NRAS | ENST00000369535.4 | 1 | 17 | G12D/C/S/A/V/R, G13R/V/C/S |
| NRAS | ENST00000369535.4 | 55 | 70 | Q61R/K/L/H |
| NRAS | ENST00000369535.4 | 115 | 121 | L120D, K117R |
| NRAS | ENST00000369535.4 | 141 | 149 | A146V/T |
| PIK3CA | ENST00000263967.3 | 538 | 553 | E545K/A/G/Q, E542K, Q546K/R/P |
| PIK3CA | ENST00000263967.3 | 1,040 | 1,065 | H1047R/L/Y, G1049R, M1043I/V |
1 Sequence source: Ensemble database
2 For the exact nucleotide coverage refer to the Plasma-SeqSensei™ Instruction for Use
| Feature | Plasma-SeqSensei™ Solid Cancer IVD Kit |
| Sample type | Whole blood and plasma |
| Sample capacity | 2–16 samples per kit and up to 32 samples with Plasma-SeqSensei™ Extension IVD Kit |
| QC function | Positive control and no template control (NTC) applied to every run |
| Compatible platforms | Illumina NextSeq 500/550™ |
| Input DNA required | 5.7–95 ng/116 µl |
| 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 |
| Limit of Quantitation | LOQ: 0.13 - 2.28% allele frequency, based on 30 MM across a validated range of 1,315-22,500 GE |
| Cat. No. | REF |
Sysmex Europe SE
Deelböge 19 D
22297 Hamburg
Germany
+49 (40) 527 26 0
+49 (40) 527 26 100
Plasma-SeqSensei™ basic online training
After completing this course, you will be able to perform liquid biopsy analyses using Plasma-SeqSensei™ Kits. This training is intended for laboratory specialists who will perform liquid biopsy analyses using Plasma-SeqSensei™ Kits.
Product documents
Regulatory documents
Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:
Go to My Sysmex
