Sysmex Europe

Plasma-SeqSensei™ Breast Cancer IVD Kit

Sensitive mutation detection and streamlined workflow

Plasma-SeqSenseiTM 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. Plasma-SeqSensei’sTM short and standardised workflow delivers results within two days, including the generation of easy-to-read reports using laptop-compatible Plasma-SeqSenseiTM IVD Software.

The kit covers key gene mutations from AKT1, ERBB2, ESR1, KRAS, PIK3CA and TP53 to detect established and emerging predictive markers, resistance mutations and frequently occurring genetic alterations in breast cancer.

 Plasma-SeqSenseiTM Breast Cancer IVD Kit is intended to support clinicians with:

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

Gene targets

Gene Transcript1 Amino acid start Amino acid end Most frequent mutations detected2
AKT1 ENST00000554581.1 17 23 E17K 
ERBB2 ENST00000269571.5 303 315 S310F 
ERBB2 ENST00000269571.5 754 769 L755S, D769Y 
ERBB2 ENST00000269571.5 770 786 V777L
ESR1 ENST00000440973.1 370 381 E380Q 
ESR1 ENST00000440973.1 460 473 S463P, L469V, F461V, L466Q 
ESR1 ENST00000440973.1 529 538 D538G, Y537S/C/N/D, L536H, N532K, V534E/L 
KRAS ENST00000256078.4 4 14 G12D/V/C/R/A/S, G13D 
PIK3CA ENST00000263967.3 86 92 R88Q 
PIK3CA ENST00000263967.3 111 117 K111E 
PIK3CA ENST00000263967.3 119 122 G118D 
PIK3CA ENST00000263967.3 345 352 E345K 
PIK3CA ENST00000263967.3 363 371 P366R 
PIK3CA ENST00000263967.3 418 421 C420R 
PIK3CA ENST00000263967.3 450 462 E453K 
PIK3CA ENST00000263967.3 538 553 E545K/A, E542K 
PIK3CA ENST00000263967.3 714 728 E726K 
PIK3CA ENST00000263967.3 1,040 1,056 H1047R/L 
TP53 ENST00000269305.4 49 77 W53* 
TP53 ENST00000269305.4 99 125 R110P 
TP53 ENST00000269305.4 126 141 C141Y, C135Y 
TP53 ENST00000269305.4 151 179 R175H, H179R 
TP53 ENST00000269305.4 192 219 R213*, Y220C, R196* 
TP53 ENST00000269305.4 233 260 R248Q/W, G245S 
TP53  ENST00000269305.4  262  285  R273H/C, R282W 
TP53  ENST00000269305.4  297  306  R306* 
TP53  ENST00000269305.4  308  331  Q331* 
TP53  ENST00000269305.4  332  360  R342* 


1 Sequence source: Ensemble database

2 For the exact nucleotide coverage refer to the Plasma-SeqSenseiTM Instruction for Use

Technical specifications
Feature Plasma-SeqSenseiTM Breast 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 500/550TM
Input DNA required 4.3–86 ng/116 µl
Number of amplicons 28
Analytical sensitivity 0.06% allele frequency at 95% certainty at 10,000 wildtype copies
Technical cut-off 6 mutant molecules
Cat. No. ZR150544
Contact us
You have a question and would like to get in touch with our experts? We look forward to receiving your enquiry.

Sysmex Europe SE

Bornbarch 1

22848 Norderstedt


+49 (40) 527 26 0

+49 (40) 527 26 100


Plasma-SeqSenseiTM basic online training

After completing this course, you will be able to perform liquid biopsy analyses using Plasma-SeqSenseiTM Kits. This training is intended for laboratory specialists who will perform liquid biopsy analyses using Plasma-SeqSenseiTM Kits.

Course page


Product documents

Regulatory documents

Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:

Go to My Sysmex

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