Plasma-SeqSensei™ Breast 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 patients with breast cancer 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 AKT1, ERBB2, ESR1, KRAS, PIK3CA, and TP53 to detect established and emerging predictive markers, resistance mutations, and frequently occurring genetic alterations in breast cancer.

PSS Breast Cancer IVD Kit is intended to support clinicians with:

  • detecting minimal residual disease
  • recurrence surveillance
  • (neo-)adjuvant response monitoring

PSS technology

Confident mutant reporting

To increase sensitivity and reduce error rates associated with sequencing, the PSS library preparation workflow employs SafeSEQ technology1. 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 0.06% 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 an internal quantifier Quantispike, which allows robust quantification of tumour-specific sequences over a broad dynamic range down to a limit of detection (LOD) of six 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. Automatically generated reports include 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.



  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.
Technical Specifications
Feature Plasma-SeqSenseiTM Breast 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 4.3–86 ng/116 µl
Number of amplicons 28
Sensitivity 0.06% allele frequency at 95% certainty at 10,000 wildtype copies
Cut-off 6 mutant molecules
Cat. No. ZR150544


Gene targets

Gene ID# Transcript ID# Coding sequence start Coding sequence end Most frequent mutations detected
AKT1 ENST00000554581 47 69 E17K
ERBB2 ENST00000269571 907 947 S310F
ERBB2 ENST00000269571 2,308 2,36 L755S, D769Y
ERBB2 ENST00000269571 2,258 2,307 V777L
ESR1 ENST00000440973 1,108 1,143 E380Q
ESR1 ENST00000440973 1,378 1,42 S463P
ESR1 ENST00000440973 1,583 1,614 D538G, Y537S/C/N
KRAS ENST00000256078 8 43 G12D/V/C/R/A/S, G13D
PIK3CA ENST00000263967 254 278 R88Q
PIK3CA ENST00000263967 329 352 K111E
PIK3CA ENST00000263967 353 367 G118D
PIK3CA ENST00000263967 1,033 1,058 E345K
PIK3CA ENST00000263967 1,085 1,115 P366R
PIK3CA ENST00000263967 1,252 1,264 C420R
PIK3CA ENST00000263967 1,348 1,387 E453K
PIK3CA ENST00000263967 1611 1659 E545K/A, E542K
PIK3CA ENST00000263967 2,138 2,184 E726K
PIK3CA ENST00000263967 3118 3169 H1047R/L
TP53 ENST00000269305 144 232 W53*
TP53 ENST00000269305 293 375 R110P
TP53 ENST00000269305 376 423 C141Y, C135Y
TP53 ENST00000269305 451 537 R175H, H179R
TP53 ENST00000269305 574 659 R213*, Y220C, R196*
TP53 ENST00000269305 695 782 R248Q/W, G245S
TP53 ENST00000269305 783 856 R273H/C, R282W
TP53 ENST00000269305 888 919 R306*
TP53 ENST00000269305 920 993 Q331*
TP53 ENST00000269305 994 1,08 R342*


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