Plasma-SeqSensei™ Breast Cancer IVD Kit

Plasma-SeqSensei™ Breast Cancer IVD Kit

Highly sensitive down to 0.06% mutant allele fractions
Quantitative detection of six mutant molecules or more with 95% confidence
Fast turnaround time of two days
Convenient data analysis and reporting with IVD-certified software

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

Features

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.

References

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. https://doi.org/10.1073/pnas.1105422108

Technical Specifications

Feature	Plasma-SeqSensei^TM 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*