Plasma-SeqSensei™ Breast Cancer IVD Kit

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

1. 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

Gene targets

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

Product documents

Regulatory Documents

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