Plasma-SeqSensei™ 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’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 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

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/P/R, 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-SeqSensei™ Instruction for Use

Technical specifications

Feature	Plasma-SeqSensei™ 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
Analytical sensitivity	Cut-off: 0.06% allele frequency on a background of 10,000 GE represent the assay´s cutoff of 6 mutant molecules (MM). LOD: 0.08-1.55% allele frequency, based on 15.52 MM across a validated range of 1,000-20,000 GE
Limit of Quantitation	LOQ: 0.25-5.00% allele frequency, based on 50 MM across a validated range of 1,000-20,000 GE
Cat. No.	REF

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Training

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.

Course page

Documents