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Extended RAS Panel

The first FDA-approved NGS in vitro diagnostic for evaluating RAS mutations in colorectal cancer to determine patient eligibility for treatment with Vectibix®.Read More...

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Praxis Extended RAS Panel

20012431

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Extended RAS Panel

Product Highlights

To evaluate mutations known to affect the efficacy of Vectibix* for treatment of metastatic colorectal cancer,1,2 Illumina offers the Extended RAS Panel. This Food and Drug Administration (FDA)-approved next-generation sequencing (NGS) kit assesses 12 codons in KRAS/NRAS to simultaneously determine the presence of 56 activating mutations.

The Extended RAS Panel is used to aid in the identification of patients eligible for treatment with Vectibix. The panel is intended to be used on the MiSeqDx instrument. On-instrument Local Run Manager software helps create a sequencing run, monitor run status, and analyze the sequencing data. It then delivers an easy-to-interpret report to guide therapy decisions accurately and efficiently.

  • First fully validated NGS-based companion diagnostic for Vectibix
    FDA-approved test to evaluate 56 KRAS/NRAS mutations in a single assay
  • Integrated, streamlined workflow
    Comprehensive diagnostic solution, including library prep, sequencing, and clinical report
  • Extended gene coverage
    Simultaneous detection of 56 RAS mutations contraindicated for Vectibix therapy3,4

*Vectibix is a registered trademark of Amgen, Inc.

Specifications

Intended Use

The Praxis™ Extended RAS Panel is a qualitative in vitro diagnostic test using targeted high throughput parallel sequencing for the detection of 56 specific mutations in RAS genes [KRAS (exons 2, 3 and 4) and NRAS (exons 2, 3 and 4)] in DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The Praxis™ Extended RAS Panel is indicated to aid in the identification of patients with colorectal cancer for treatment with Vectibix® (panitumumab) based on a no mutation detected test result. The test is intended to be used on the Illumina MiSeqDx instrument.

Relevant Warnings and Limitations

  • For prescription use only.
  • Optimal performance of the test requires appropriate sample handling as described in the instructions for use.
  • The Extended RAS Panel Report only determines the presence or absence of the KRAS and NRAS mutations listed in the package insert.
  • For samples that pass the DNA qualification step based on requirements described in the instructions for use, the assay has an estimated invalid rate of 6.9% to 14.5% as assessed in the retrospective clinical and accuracy studies, respectively.
  • The risks of the Extended RAS Panel are associated with the potential mismanagement of patients resulting from false results of the test. A false positive test result may lead to Vectibix treatment being withheld from a patient who might have benefitted. A false negative test result may lead to Vectibix treatment being administered to a patient who is not expected to benefit, therefore potentially exposing them to any adverse side effects associated with this therapy and also causing the patient to possibly fail to receive a different drug that might be more appropriate for them than Vectibix.
  • Laboratories should follow safety procedures and use personal protective equipment, as some components contain potentially hazardous chemicals and personal injury can occur through inhalation, ingestion, skin contact, and eye contact.

References

Extended RAS Panel Package Insert.

Summary of Safety and Effectiveness Data.

Vectibix full Prescribing Information, including Boxed Warnings.

For In Vitro Diagnostic Use.

Contact an Illumina representative for regional availability.

Extended RAS Panel Workflow

 
Prepare Library for:
Molecular Diagnostics
 
Sequence Efficiently with:
MiSeqDx Instrument
 
Analyze Your Data with:
Local Run Manager Software
 

Supporting Data and Figures

Comprehensive Mutation Detection by the Extended RAS Panel
Comprehensive Mutation Detection by the Extended RAS Panel

ASCP, CAP, AMP, and ASCO guidelines recommend confirmation of KRAS/NRAS mutational status before treatment of mCRC with anti-EGFR therapy.3 Targeted sequencing provides deep coverage of each relevant codon and detects the presence of 56 activating mutations contraindicated for Vectibix treatment, as compared to wild-type.

 

Product Literature

Extended RAS Panel

Data Sheet | PDF < 1 MB

Manuals and Support Information

Extended RAS Panel Support Documentation

All Praxis Extended RAS Panel Support 

All Extended RAS Panel Support 

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References
  1. Allegra CJ, Rumble RB, Hamilton SR, et al. Extended RAS Gene Mutation Testing in Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015. J Clin Oncol. 2016;34(2):179-185
  2. Al-Shamsi HO, Alhazzani W, Wolff RA. Extended RAS testing in metastatic colorectal cancer-Refining the predictive molecular biomarkers. J Gastrointest Oncol. 2015;6(3):314-3
  3. Sepulveda AR, Hamilton SR, Allegra CJ, et al. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology. J Mol Diagn. 2017;19(2):187-225.
  4. Extended RAS Panel Package Insert
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