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Plasma-SeqSensei™ Solid Cancer IVD Kit

Plasma-SeqSensei™ (PSS) 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. PSS'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 such as BRAF, EGFR, KRAS, NRAS and PIK3CA to detect established and emerging predictive markers, resistance mutations, and frequently occurring genetic alterations in cancer.

PSS 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
More details

PSS technology

Confident mutant reporting

To increase sensitivity and reduce error rates associated with sequencing, the PSS library preparation workflow employs SafeSEQ technology 1 . This technology assigns a unique identifier (UID) to each DNA molecule during the target selection step. UIDs help track and identify real mutations in samples and distinguish them from polymerase or sequencing errors. PSS detects 0.07% and higher mutant allele fractions (MAF) with 95% certainty in a background of 10,000 wild-type copies.

Beyond MAF – absolute mutant quantification

PSS technology utilises internal quantifier Quantispike, which allows robust quantification of tumour-specific sequences over a broad dynamic range down to a limit of detection (LOD) of seven mutant molecules. Additionally, absolute quantification reported as a number of mutant molecules detected in the tested volume of blood helps to facilitate a meaningful comparison of changes in ctDNA levels over time. 

Plasma-SeqSensei™ IVD Software

PSS IVD Software offers the possibility to effortlessly plan and analyse sequencing runs and report data easily. It is the first IVD-certified software designed to run on an office PC or laptop – no workstation or server structure is needed. The interface is divided into three functional modules: run planning, data analysis and reporting. The automatically generated report includes sample metrics and mutation status, both listing MAFs as well as the absolute number of mutant molecules detected in the sample volume, alongside sequencing quality metrics.

 

References

  1. Kinde, I., Wu, J., Papadopoulos, N., Kinzler, K. W., & Vogelstein, B. (2011). Detection and quantification of rare mutations with massively parallel sequencing. Proceedings of the National Academy of Sciences of the United States of America, 108(23), 9530–9535. https://doi.org/10.1073/pnas.1105422108
Technical specifications
Feature Plasma-SeqSenseiTM Solid Cancer IVD Kit
Sample type Whole blood and plasma
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™
Input DNA required 5.7–95 ng/116 µl
Number of amplicons 17
Sensitivity 0.07% allele frequency at 95% certainty at 10,000 wildtype copies
Cut-off 7 mutant molecules
Cat. No. ZR150534

 

Gene targets

Gene Transcript* Coding sequence start Coding sequence end Most frequent mutations detected (AA change)
BRAF ENST00000288602 1,383 1,431 G469A/R/V/E, G466V/E
BRAF ENST00000288602 1,742 1,813 V600E/K/R/M, K601E, D594G
EGFR ENST00000275493 2,116 2,177 G719A/S
EGFR ENST00000275493 2,565 2,620 L858R, L861Q
EGFR ENST00000275493 2,225 2,279 E746_A750del, L747_P753delinsS, L747_T751del, L747_A750delinsP, E746_S752delinsV
EGFR ENST00000275493 2,361 2,403 T790M
EGFR ENST00000275493 2,284 2,325 S7681I
KRAS ENST00000256078 419 445 A146T/V
KRAS ENST00000256078 326 352 K117N
KRAS ENST00000256078 34 102 G12D/V/C/A/S/R/F, G13D/C/R/V/A
KRAS ENST00000256078 169 102 Q61H/R/L/H/K, A59T
NRAS ENST00000369535 162 210 Q61R/K/L/H
NRAS ENST00000369535 420 449 A146V/T
NRAS ENST00000369535 1 52 G12D/C/S/A/V/R, G13R/V/C/S
NRAS ENST00000369535 341 364 L120D, K117R
PIK3CA ENST00000263967 3,118 3,195 H1047R/L/Y, G1049R, M1043I/V
PIK3CA ENST00000263967 1,611 1,659 E545K/A/G/Q, E542K, Q546K/R/P

 

Contact

Sysmex Europe SE

Bornbarch 1

22848 Norderstedt

Germany

+49 (40) 527 26 0

+49 (40) 527 26 100

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