Plasma-SeqSensei™ Breast Cancer IVD Kit
Discover the benefits of our Breast Cancer IVD Kit
- highly sensitive down to 0.06% mutant allele fraction
- quantitative detection of six mutant molecules or more with 95% confidence
- 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-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-SeqSensei™ 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-SeqSensei™ Breast Cancer IVD Kit is intended to support clinicians with:
- detecting minimal residual disease
- recurrence surveillance
- (neo-)adjuvant response monitoring
Gene targets
| Gene | Transcript* | Amino acid start | Amino acid end | Most frequent mutations detected** |
| 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 |
* Sequence source: Ensemble database
** For the exact nucleotide coverage refer to the Plasma-SeqSenseiTM Instruction for Use
| 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 500/550™ |
| 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 |
Sysmex Europe SE
Bornbarch 1
22848 Norderstedt
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
