Plasma-SeqSensei™ Breast Cancer IVD Kit
Discover the benefits of our Breast Cancer IVD Kit
- highly sensitive down to 0.06% mutant allele fraction
- 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-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
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
| 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 |
Sysmex Europe SE
Bornbarch 1
22848 Norderstedt
Germany
+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.
Product documents
Regulatory documents
Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:
Go to My Sysmex
