SensiScreen® Liquid assays are designed for early detection and monitoring of somatic mutations in liquid biopsies using standard equipment. With SensiScreen® Liquid, it is possible to monitor changing levels of cancer mutations and detect newly developed mutations in cell-free DNA (cfDNA) shed into the blood or other liquid biopsies. In this way, SensiScreen® Liquid can support the selection of the most appropriate personalized treatment in a timely manner.
SensiScreen® Liquid are real-time PCR-based assays that combine high sensitivity with ease-of-use and are designed to work on standard real-time PCR equipment. Sensitive detection of somatic mutations by SensiScreen® is achieved with PentaBase’s novel and selective INA® technologies including the use of BaseBlockers™ that suppress false positive signals from wild type templates. Thus, SensiScreen® Liquid assays are able to detect down to a single copy of mutated DNA in a background of wild type DNA.
Format
SensiScreen® assays are supplied as either “Ready-to-use” or as “Dispense Ready” mixes. Ready-to-use assays are pre-dispensed in PCR strips and require only addition of gDNA for somatic mutation testing. Dispense-ready mixes include oligonucleotides and master mix in separate tubes ready to be dispensed and added gDNA. The technologies are applicable on standard real-time equipment using standard procedures and results can be ready in less than three hours from receiving a sample (including automated DNA extraction).
Covered Mutations
SensiScreen® Liquid assays cover the most common clinically relevant cancer mutations including those in BRAF, EGFR, KRAS and NRAS genes. Explore the mutations below or refer to the Instructions For Use for more details. Please note that all SensiScreen® assays are also available as an FFPE version for detection in solid biopsies.
Visit our SensiScreen® product page for prices and more information.
Liquid Mutations
Intended useSensiScreen® BRAF V600 Liquid assays are real-time PCR-based assays intended for identification of the mutations V600D/E/K/R in the BRAF gene. SensiScreen® BRAF V600 Liquid assays are CE-IVD marked in accordance with EU Directive 98/79/EC on Medical Equipment for in vitro diagnostics.
Detection of BRAF mutations by SensiScreen® Liquid include the following assays:
| Assay | Status |
|---|---|
| BRAF V600D/E/K/R Multiplex | CE-IVD |
| BRAF V600D/E/K/R Simplex | CE-IVD |
| BRAF V600E Simplex | CE-IVD |
Intended use:SensiScreen® EGFR Liquid assays are real-time PCR-based assays intended for identification of mutations in exons 18, 19, 20 and 21 of the EGFR gene. SensiScreen® EGFR Exon 19 Deletions, T790M and L858R Liquid assays are CE-IVD marked in accordance with EU Directive 98/79/EC on Medical Equipment for in vitro diagnostics. The remaining SensiScreen® EGFR Liquid assays are intended for research applications only.
Detection of EGFR mutations by SensiScreen® Liquid include the following assays:
| Assay | Status |
|---|---|
| EGFR Exon 18+19+20+21 | RUO |
| EGFR G719A/C/S | RUO |
| EGFR Exon 19 Deletions (35 deletions) | CE-IVD |
| EGFR S768I | RUO |
| EGFR T790M | CE-IVD |
| EGFR Exon 20 Insertions (22 insertions) | RUO |
| EGFR L858R | CE-IVD |
| EGFR L861Q | RUO |
| EGFR Exon 19 Deletions+T790M+L858R | CE-IVD |
Intended useSensiScreen® KRAS Liquid assays are real-time PCR-based assays intended for identification of mutations in codons 12, 13, 59, 61, 117 and 146 of the KRAS gene. SensiScreen® KRAS Liquid assays are intended for research applications only.
Detection of KRAS mutations by SensiScreen® Liquid include the following assays:
| Assay | Status |
|---|---|
| KRAS Exon 2+3+4 Multiplex | RUO |
| KRAS Exon 2 Multiplex G12A/C/D/R/S/V G13D | RUO |
| KRAS Exon 3 Multiplex Q61H1/H2/E/K/L/R A59G/T | RUO |
| KRAS Exon 4 Multiplex K117N1/N2 A146P/T/V | RUO |
| KRAS Exon 2 Simplex G12A/C/D/R/S/V G13D | RUO |
| KRAS Exon 3 Simplex Q61H1/H2/E/K/L/R A59G/T | RUO |
| KRAS Exon 4 Simplex K117N1/N2 A146P/T/V | RUO |
Intended use:The SensiScreen® KIT Liquid assay is a real-time PCR-based assay intended for identification of the KIT D816V mutation. The SensiScreen® KIT Liquid assay is intended for research appplications only.
Detection of KIT mutations by SensiScreen® Liquid includes the following assay:
| Assay | Status |
|---|---|
| KIT D816V | RUO |
Intended useSensiScreen® NRAS Liquid assays are real-time PCR-based assays intended for identification of mutations in codons 12, 13, 59, 61, 117 and 146 of the NRAS gene. SensiScreen® NRAS Liquid assays are intended for research applications only.
Detection of NRAS mutations by SensiScreen® Liquid include the following assays:
| Assay | Status |
|---|---|
| NRAS Exon 2+3+4 Multiplex | RUO |
| NRAS Exon 2 Multiplex G12A/C/D/R/S/V G13A/C/D/R/S/V | RUO |
| NRAS Exon 3 Multiplex Q61H1/H2/K/L/R A59D/T | RUO |
| NRAS Exon 4 Multiplex K117N1/N2 A146P/T/V | RUO |
| NRAS Exon 2 Simplex G12A/C/D/R/S/V G13A/C/D/R/S/V | RUO |
| NRAS Exon 3 Simplex Q61H1/H2/K/L/R A59D/T | RUO |
| NRAS Exon 4 Simplex K117N1/N2 A146P/T/V | RUO |
Intended useSensiScreen® PIK3CA H1047 Liquid assays are real-time PCR-based assays intended for identification of the mutations H1047L/R/Y in the PIK3CA gene. SensiScreen® PIK3CA H1047 FFPE assays are intended for research applications only.
Detection of PIK3CA mutations by SensiScreen® Liquid include the following assays:
| Assay | Status |
|---|---|
| PIK3CA H1047L/R/Y Multiplex | RUO |
| PIK3CA H1047L/R/Y Simplex | RUO |
Key features and benefits of SensiScreen® for liquid biopsies
- Liquid sample analysis: Liquid version for analysis of liquid biopsies containing small amounts of DNA.
- High Sensitivity: SensiScreen® Liquid detects down to one copy of mutated DNA in a wild type DNA background of up to 5 ng.
- Easy and fast: Easy to setup (hands-on-time <2 min/sample) and takes less than three hours from sample to result including DNA extraction.
- State of the art: Based on PentaBase’s proprietary INA® technology.
- Proven: SensiScreen® CE IVD assays are clinically validated in Switzerland and Denmark, and are certified in accordance to the EU guidelines 98/79/EC Medical equipment for in vitro diagnostics.
- Simplex and multiplex: Supplied in multiplex configurations for mutation screening and simplex configurations for genotyping and monitoring.
- Open qPCR platform designs: Designed to work on standard real-time PCR instruments and validated on commonly used platforms:.
| Rotor-Gene Q (Qiagen) | CFX96™ (Bio-Rad) |
| MX3000P/3005P (Agilent) | ABI 7500/7900HT/QuantStudio™ 12K Flex (Applied Biosystems) |
| LightCycler® 96 + 480 (Roche) | MyGo Pro (IT-IS Life Science) |
| Mic (Bio Molecular Systems) |
Experimental Data Example
The figures below illustrate a SensiScreen® Liquid assay detecting one copy of mutated DNA. Real-time PCR amplification of 12 replications of patient DNA Heterozygous for an EGFR Exon 19 Deletion diluted to approximately 3 copies per well was performed.
