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Roche Oncology Life Science Research Kits

Our answers. Your insights.

The Roche Oncology Life Science Research (LSR) kits are complete testing kits designed to fuel your oncology research. With broad coverage of relevant mutations, high analytical sensitivity, and a complimentary web application to analyze your data, the Roche Oncology LSR kits provide the information you need to garner real insights for oncology research.

The BRAF/NRAS Mutation Test and KRAS Mutation Test v2 come with access to a real-time data analysis tool for automated, objective interpretation of results, while still giving you the raw data that can help in developing important insights. The BRAF/NRAS Mutation Test and KRAS Mutation Test v2 are indicated for both formalin-fixed paraffin-embedded tissue (FFPET) and plasma sample types, and run on the cobas z 480 analyzer.

 

 

 

Fast time to results and simple results reporting

Watch this example video to see the workflow of the LSR assays, highlighting the BRAF/NRAS Mutation Test, its key features and attributes, rapid turnaround time, and a step-by-step walkthrough of the simple results reporting. The workflow highlighted in this video also applies to the KRAS Mutation Test v2.

Frequently Asked Questions

No, when you use the Data Analysis tool, results are delivered direct to you. Roche does not store, view or use your data.

Interpreted data is available for 24 hours. After this period, data will need to be re-uploaded for reinterpretation.

Once you upload the raw data into the online Data Analysis tool, the results are delivered to you within a few minutes.

Turn on the cobas z 480 analyzer if it is turned off. If necessary, reboot the cobas® 4800 workstation and log into the User defined Workflow (UDF) partition on the system. Once the system has booted up, follow the appropriate assay Instructions for Use for more information on the Run Setup.

Roche recommends the cobas® DNA Sample Preparation Kit, however, the Roche Oncology LSRs are robust enough to work with a variety of DNA sample preparation methods. Per the Instructions for Use, the test requires 150ng of genomic DNA. Please see the appropriate assay Instructions for Use for more detailed information regarding DNA preparation.

The Roche Oncology LSRs come with the same quality of support you get with other Roche assays. Roche representatives are available for troubleshooting and training as needed. For specific questions and concerns, please contact your local Roche representative.

The Data Analysis tool is best viewed in Google Chrome 3 or above, Mozilla Firefox 3.5 or above, and Microsoft Internet Explorer 7 or above.

Data Analysis

 

The LSR Data Analysis tool is a free1 service that gives researchers access to Roche Diagnostics' unique testing algorithms to automatically interpret data generated by the Oncology LSR test kits. Rather than having to analyze all of the individual data points manually, researchers can have data files analyzed and results generated in .pdf and .csv documents within minutes.

This application is supported only on laptops/desktops. Please access the webpage in desktop/laptop.

 

 

Watch the example video

See the workflow of the LSR assays, highlighting the BRAF/NRAS Mutation Test, its key features and attributes, rapid turnaround time, and a step-by-step walkthrough of the simple results reporting. The workflow highlighted in this video also applies to the KRAS Mutation Test v2.



Frequently Asked Questions

No, when you use the Data Analysis tool, results are delivered direct to you. Roche does not store, view or use your data.

Interpreted data is available for 24 hours. After this period, data will need to be re-uploaded for reinterpretation.

Once you upload the raw data into the online Data Analysis tool, the results are delivered to you within a few minutes.

 

BRAF/NRAS Mutation Test (LSR)

The BRAF/NRAS Mutation Test* is an allele-specific, real-time polymerase chain reaction (PCR) test for the qualitative detection and identification of exon 11 and 15 mutations in the proto-oncogene B-Raf (BRAF) gene, and exon 2, 3, and 4 mutations in the neuroblastoma RAS (NRAS) viral oncogenes.

The BRAF/NRAS Mutation Test* can be used with both formalin-fixed paraffin embedded tissue (FFPET) and plasma sample types. The test offers broad detection of BRAF and NRAS mutations within an 8 hour laboratory shift, and comes with liquid, ready-to-use reagents to increase laboratory efficiency.

 

Key Features and Benefits

  • Results from a single, 5µm FFPET section of tissue or 2mL plasma
  • 100% repeatability over multiple specimens, operators, instruments, and days1
  • Sensitivity >= 5% mutant alleles in a wild-type in DNA isolated from FFPET samples
  • Sensitivity as low as 100 copies/mL in DNA isolated from plasma samples
  • Ability to combine run with KRAS v2 (LSR) for expanded mutation testing in a same test run
  • Ability to add FFPET and plasma sample types in same test run
  • > 98% overall concordance to NGS for FFPET and plasma
  • Complimentary access to the LSR Data Analysis tool to interpret your data** with results available in minutes



LSR testing workflow

Coverage of the BRAF/NRAS Mutation Test (LSR):
NRAS COSMIC v.80   SKIN COLON
Freq of Reports LSR Coverage Freq of Reports LSR Coverage
exon 2 13.0% 11.8% 42.9% 42.4%
exon 3 86.6% 84.4% 55.8% 54.7%
exon 4 <1%
<1% <1% <1%
TOTAL 99.5% 96.3% 98.7% 97.1%
BRAF COSMIC v.80   SKIN COLON
Freq of Reports LSR Coverage Freq of Reports LSR Coverage
exon 11 <1% <1% <1% <1%
exon 15 98.7% 96.3% 99.4% 98.4%
TOTAL 99.0% 96.5% 99.6% 98.5%
Porudct Description Quantity Material Number
BRAF/NRAS Mutation Test (LSR) 24 07659962001
cobas® 4800 UDF v2.0.0 CD 1 07540922001
cobas® 4800 Microwell Plate and Sealing Foil 50 05232724001

References

1. BRAF/NRAS LSR Package Insert

*For research use only
**Roche does not maintain or store uploaded data, and sample identifying information is not collected. Files are only downloadable for a limited time.

 

KRAS Mutation Test v2 (LSR)

The KRAS Mutation Test v2 (LSR) from Roche is an allele-specific, real-time PCR test for the qualitative detection and identification of 28 mutations in exons 2, 3, and 4 of the v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) gene from FFPET and plasma samples.

 

Key Features and Benefits

  • Broad detection of KRAS mutations within an 8-hour laboratory shift
  • Results from a single, 5µm FFPET section of tissue or 2mL plasma
  • Liquid, ready-to-use reagents to increase laboratory efficienc
  • 100% repeatability over multiple specimens, operators, instruments and days
  • KRAS v2 FFPET reports now display KRAS G12C separately
  • Sensitivity =1% mutant alleles in a wild-type in DNA isolated from FFPET samples
  • Sensitivity of =100 copies/mL in DNA isolated from plasma samples
  • Ability to combine test run with BRAF/NRAS (LSR) for expanded mutation testing in same test run
  • Ability to add FFPET and plasma sample types in same test run
  • > 99% overall concordance to NGS for FFPET and 92% overall concordance to NGS for

1. KRAS v2 LSR Package Insert

 





KRAS v2 LSR testing workflow

When you’re on the path to discovery, every result matters. Every answer could be the one that gets you there. To the revelation you were searching for. To the advancement you needed. To your next breakthrough. The Roche Life Science Research Assay Portfolio offers the speed, accuracy, and open-source flexibility your research demands. So you get clear, actionable results faster, in fewer shifts, and backed by the exacting standards, quality, and service of Roche.

Roche does NOT maintain or store uploaded data and no sample identifying information is collected. Files are only downloadable for a limited time.

 

Coverage of the KRAS Mutation Test v2 (LSR):
KRAS COSMIC v.81   COLON LUNG PANCREAS
Freq of Reports LSR Coverage Freq of Reports LSR Coverage Freq of Reports LSR Coverage
exon 2 98.3% 97.7% 98.7% 97.7% 98.8% 98.3%
exon 3 1.0% 0.9% 1.2% 1.1% 1.1% 1.0%
exon 4 0.7% 0.5% 0.06% 0.04% 0.08% 0.04%
all others* 0.01% 0.0% 0.04% 0.0% 0.0% 0.0%
TOTAL 100.0% 99.1% 100.0% 98.8% 100.0% 99.3%

* mutations outside exon 2, 3 and 4.

Product Description Quantity Material Number
KRAS Mutation Test v2 (LSR) 24 07989270001
cobas® 4800 UDF v2.0.0 CD 1 07540922001
cobas® 4800 Microwell Plate and Sealing Foil 50 05232724001