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SensiScreen® – PentaBase ApS

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PentaBase ApS is a privately held company founded in 2006, having roots back to the invention Intercalating Nucleic Acid, INA®, made by the founder of PentaBase, Ulf B. Christensen and published in 2002 [Christensen UB and Pedersen EB, Nucl. Acid. Res., 2002, 30, 4918-4925]. Today PentaBase has refined INA®, and made it compatible with standard, open platform instruments used in most molecular biology facilities around the world. We call the proprietary monomers in our updated INA for “pentabases”.

 

(PentaBase’s website is here

 


 

SensiScreen® 

―Assays for Sensitive Detection of Cancer Mutations―

 

SensiScreen® are real-time PCR-based assays for somatic mutation detection in cancer patients. SensiScreen® combines high sensitivity with multiplexing capabilities and 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.

 

Key features

High sensitivity – down to one copy detection

Simplex and multiplex configurations

●Detection in solid and liquid biopsies

Open platform designs

 

From sample to answer in less than three hours

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 technology is 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).

 

pentabase1

 

 

Technology

Ultra-sensitive detection of somatic mutations by SensiScreen® is possible with PentaBase’s novel and
selective technologies, comprising:

1, HydrolEasy™ probes with significantly improved signal-to-noise ratio and higher specificity compared to conventional hydrolysis probes.

2, Suprimer™ DNA primers modified with pentabases for specific and sensitive amplification.

3, BaseBlockers™ suppressing false positive signals from wild type templates and ensuring high specificity. and robustness of the assays.

 

pentabase2

 

 

Features

Solid and liquid sample analysis: Supplied in both an FFPE version for analysis of solid biopsies and a liquid version for analysis of liquid biopsies containing small amounts of DNA.

High Sensitivity: SensiScreen® FFPE assays have a limit of detection between 0.1% and 1% mutant DNA in a wild type background. SensiScreen® Liquid detects down to one copy of mutant DNA.

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. Finds more true mutation positive samples compared to other common methods for somatic mutation testing (Riva et al. 2017).

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*.

 


pentabase3

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 circulating cell-free DNA (ccfDNA) shed into the blood or other liquid samples. In this way, SensiScreen® Liquid can support the selection of the most appropriate personalized treatment in a timely manner. SensiScreen® Liquid assays are able to detect down to a single copy of mutated DNA in a background of wild type DNA.

 

Key features

・Analysis of liquid biopsies

Early detection and monitoring of cancer DNA biomarkers

・Detects down to 1 copy of mutated DNA

From biopsy to result in less than 3 hours

 

 

Detecting down to one copy

The figures below illustrates a SensiScreen® Liquid assay detecting one copy of mutant DNA. 12 identical of a patient DNA Heterozygous for an EGFR Exon 19 Deletion divided to approximately 3 copies per. well were carried out.

pentabase4

 SensiScreen Liquid product list

Cat. No Name Volume
1700-1702 KRAS EXON2+3+4 Multiplex (K1) 1/12/60 reactions
1705-1707 KRAS EXON2 Multiplex (K2) 1/12/60 reactions
1710-1712 KRAS EXON3 Multiplex (K3) 1/12/60 reactions
1715-1717 KRAS EXON4 Multiplex (K4) 1/12/60 reactions
1720-1722 KRAS EXON2 Simplex (K5+K6) 1/12/60 reactions
1725-1727 KRAS EXON2 Simplex (K5) 1/12/60 reactions
1730-1732 KRAS EXON2 Simplex (K6) 1/12/60 reactions
1735-1737 KRAS EXON3 Simplex (K7+K8) 1/12/60 reactions
1740-1742 KRAS EXON3 Simplex (K7) 1/12/60 reactions
1745-1747 KRAS EXON3 Simplex (K8) 1/12/60 reactions
1750-1752 KRAS EXON4 Simplex (K9+K10) 1/12/60 reactions
1755-1757 KRAS EXON4 Simplex (K9) 1/12/60 reactions
1760-1762 KRAS EXON4 Simplex (K10) 1/12/60 reactions
1770-1772 NRAS EXON2+3+4 Multiplex (N1) 1/12/60 reactions
1775-1777 NRAS EXON2 Multiplex (N2) 1/12/60 reactions
1780-1782 NRAS EXON3 Multiplex (N3) 1/12/60 reactions
1785-1787 NRAS EXON4 Multiplex (N4) 1/12/60 reactions
1790-1792 NRAS EXON2 Simplex (N5+N6) 1/12/60 reactions
1795-1797 NRAS EXON2 Simplex (N5) 1/12/60 reactions
1800-1802 NRAS EXON2 Simplex (N6) 1/12/60 reactions
1805-1807 NRAS EXON3 Simplex (N7+N8) 1/12/60 reactions
1810-1812 NRAS EXON3 Simplex (N7) 1/12/60 reactions
1815-1817 NRAS EXON3 Simplex (N8) 1/12/60 reactions
1820-1822 NRAS EXON4 Simplex (N9) 1/12/60 reactions
1830-1832 BRAF V600 Multiplex (B1) 1/12/60 reactions
1835-1837 BRAF V600 Simplex (B2) 1/12/60 reactions
1840-1842 BRAF V600E Simplex (B3) 1/12/60 reactions

pentabase5

 

Detection in solid biopsies

SensiScreen® FFPE assays are designed for detection of somatic mutations from genomic DNA in solid biopsies (fresh, frozen or FFPE tissue) or other samples with high amounts of DNA (load up to 50 ng).
SensiScreen® FFPE assays are able to robustly detect 0.25-1 % mutation in a 50 ng wild type background.

 

Key features

Analysis of primary tumors and metastases

Multiplex assays for screening of cancer mutation hotspots

Simplex assays for genotyping and confirmation

・FFPE assays are applicable to fresh, frozen or FFPE biopsies

 

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Rotor-Gene 6000 PCR amplification plots of SensiScreen® KRAS G12V simplex and multiplex assays using serial dilutions of mutated DNA in a wild type background. 50 ng (about 16.000 copies) of human genomic DNA was added to each reaction. The threshold was set at 10% of the average fluorescence signal of the reference assay at cycle 45. Legend describes the fraction of mutated G12V cell line DNA in a WT background. 0.01% corresponds to 1-2 copies of mutant DNA. For sensitivties of other KRAS Exon 2 hotspot mutations, please refer to Riva et al. 2017.

 

 SensiScreen FFPE product list

Cat. No Name Volume
1900-1901 KRAS EXON2+3+4 Multiplex 20/50 reactions
1905-1906 KRAS EXON2 Multiplex 20/50 reactions
1910-1911 KRAS EXON3 Multiplex 20/50 reactions
1915-1916 KRAS EXON4 Multiplex 20/50 reactions
1920-1921 KRAS EXON2 Simplex A+B 20/50 reactions
1925-1926 KRAS EXON2 Simplex A 20/50 reactions
1930-1931 KRAS EXON2 Simplex B 20/50 reactions
1935-1936 KRAS EXON3 Simplex A+B 20/50 reactions
1940-1941 KRAS EXON3 Simplex A 20/50 reactions
1945-1946 KRAS EXON3 Simplex B 20/50 reactions
1950-1951 KRAS EXON4 Simplex A+B 20/50 reactions
1955-1956 KRAS EXON4 Simplex A 20/50 reactions
1960-1961 KRAS EXON4 Simplex B 20/50 reactions
2000-2001 NRAS EXON2+3+4 Multiplex 20/50 reactions
2005-2006 NRAS EXON2 Multiplex 20/50 reactions
2010-2011 NRAS EXON3 Multiplex 20/50 reactions
2015-2016 NRAS EXON4 Multiplex 20/50 reactions
2020-2021 NRAS EXON2 Simplex A+B 20/50 reactions
2025-2026 NRAS EXON2 Simplex A 20/50 reactions
2030-2031 NRAS EXON2 Simplex B 20/50 reactions
2035-2036 NRAS EXON3 Simplex A+B 20/50 reactions
2040-2041 NRAS EXON3 Simplex A 20/50 reactions
2045-2046 NRAS EXON3 Simplex B 20/50 reactions
2050-2051 NRAS EXON4 Simplex 20/50 reactions
1398-1399 BRAF V600 Multiplex 20/50 reactions
1402-1403 BRAF V600 Simplex 20/50 reactions
1400-1401 BRAF V600E Simplex 20/50 reactions

 

Please contact us for your any inquiries, questions and information requests.

Tokyo Future Style, Inc.

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TEL : +81-29-851-9222

FAX : +81-29-851-9220

 

 

 

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For the development of human life science | Future-oriented Tradingcompany | Global marketing | Tokyo Future Style, Inc.