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Biocartis Idylla MSI Assay (6 tests/pack), CE-IVD

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Greitas pristatymas

SKU A0100/6

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For professional/laboratory use only.

The Idylla™ MSI Test is intended for the qualitative detection of a novel panel of seven monomorphic homopolymer biomarkers for identification of colorectal cancers (CRC) with microsatellite instability (MSI).

The Idylla™ MSI Test uses formalin-fixed, paraffin-embedded (FFPE) tissue sections from human CRC tissue, from which nucleic acids are liberated, then analyzed by PCR amplification and high-resolution melting detection. The Idylla™ MSI Test automates the entire process from FFPE sample preparation to reporting of MSI status. The fully automated IdyllaTM MSI Test performs the detection of microsatellite instability directly from formalin-fixed paraffin embedded (FFPE) human cancer tissue sections utilizing a PCR reaction followed by high-resolution melting curve analysis. The fully automated samples-to-result process with integrated automated software interpretation and reporting makes this MSI analysis fast and easy-to-use in virtually any laboratory setting.

The fully automated IdyllaTM MSI Test performs detection of mutations in 7 novel MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2). These biomarkers are tumor-specific, show a high frequency in colorectal cancer and are stable across different ethnicities ensuring excellent specificity of the test. In addition, these tumor-specific biomarkers do not require the analysis of paired normal tissue samples associated with traditional MSI/dMMR testing. With its high concordance (> 97%) and low failure rates compared to standard methods, the IdyllaTM MSI Test provides a fast, convenient and reliable alternative for any lab.

· 7 novel tumor-specific biomarkers
· 150 minutes assay turnaround time
· <2 minutes hands-on time
· No need for paired tissue
· Highly sensitive & standardized
· Unbiased result reporting

Specifikacija

Specifikacija
Pack Size

6 tests/pack

Sample Type

FFPE tissue sections (5 to 10 µm)

Tissue Area

50–600 mm² (5 µm)25-300 mm² (10 µm)

Analytical sensitivity

10% LOD

Total turnaround time

150 minutes

Dokumentai

Idylla_MSI-IVD_Tech-Sheet.pdf

Idylla MSI IVD Technical Sheet

EN | 114,246 KB

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Specimen_Req_2021-05-02-100844.pdf

Specimen Requirements

EN | 115,054 KB

Download

EN |

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Contact

Nova Natura UAB

Kaštonų g. 56, Giraitės k, LT-54310,
Kaunas, Lithuania

nova@novabio.lt
Phone: +370 (620) 70159

Reg No 305063819

Nova Natura OÜ

Valukoja 8, 11415,
Tallinn, Estonia

nova@novabio.ee
Phone: +372 5656 0050

Reg No 14758203

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