Colorectal cancer KRAS — Oncologists

 

QIAGEN, a leader in companion diagnostics, provides the fist comprehensively validated FDA-approved KRAS test, the therascreen KRAS test. This assay is approved for use as a companion diagnostic with both ERBITUX and Vectibix, two drug therapies for patients with metastatic colorectal cancer (mCRC).
Information for Oncologists
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The therascreen KRAS test is:

  • The first comprehensively validated FDA-approved test for KRAS mutation detection
  • Approved based on Phase III clinical trial data of both ERBITUX and Vectibix of patients with KRAS wild-type tumor
  • A standardized assay for reproducible results

Ask for the therascreen KRAS test at diagnosis. Identify your mCRC patients with KRAS wild-type tumor.

About the therascreen KRAS test
Reimbursement
Find out about ERBITUX for your patients
Find out about Vectibix for your patients
Back to toptherascreen KRAS RGQ PCR Kit (therascreen KRAS test) clinical data

The therascreen KRAS test is approved based on Phase III clinical trial data with both ERBITUX and Vectibix treatment of patients with KRAS mutation-negative (wild-type) tumors.

Clinical study supporting use with cetuximab (ERBITUX): Clinical trial CA225025
  • Multicenter, open-label, randomized, clinical Phase III trial conducted in 572 patients with EGFR-expressing mCRC
  • Patients randomized (1:1) to receive either ERBITUX plus best supportive care (BSC) or BSC alone
  • KRAS status was evaluated by an independent specialized laboratory using the therascreen KRAS test
  • KRAS evaluable status available for 453/572 (79%) of the patients: 245 (54%) patients had KRAS mutation-negative (wild-type) tumors and 208 (46%) patients had KRAS mutant tumors
  • Prospectively planned, retrospective analyses of efficacy and safety in patient subsets with KRAS wild-type and KRAS-mutant tumors were conducted

The main outcome measure of the study was overall survival (OS). For the KRAS mutation-negative (wild-type) population, median survival time (95% CI) was 8.6 (7.0, 10.3) months in the cetuximab+BSC group and 5.0 (4.3, 5.7) months in the BSC group. The OS hazard ratio of cetuximab+BSC over BSC was 0.63. The 95% confidence interval (CI) was (0.47, 0.84).

For the KRAS mutation-positive population, median survival time was 4.8 (3.9, 5.6) months in the cetuximab+BSC group and 4.6 (3.6, 4.9) months in the BSC group. The hazard ratio was 0.91 with 95% CI (0.67, 1.24).

Overall survival rates based on Kaplan-Meier estimates at months 6 and 12 were higher for the cetuximab+BSC group than the BSC group for the KRAS mutation-negative (wild-type) subset. This advantage was not observed in the KRAS mutant subset.

Clinical study supporting use with panitumumab (Vectibix): Clinical trial 20050203
  • Multicenter, prospective, open‐label, randomized phase III study
  • Banked tumor samples from patients were tested with the KRAS Kit to identify two subgroups: KRAS mutation-positive (mutant KRAS) and KRAS mutation-negative (wild-type KRAS)
  • KRAS status was evaluated by an independent specialized laboratory using the therascreen KRAS test
  • Assess the efficacy of panitumumab in combination with oxaliplatin, 5‐fluorouracil (5‐FU), and leucovorin (FOLFOX) vs. FOLFOX alone in patients with previously untreated, recurrent metastatic colorectal cancer (mCRC)
  • Prospectively planned, retrospective analyses of efficacy and safety in patient subsets with KRAS wild-type and KRAS-mutant tumors were conducted

Among patients with KRAS mutant tumors, median PFS was 7.3 months (95% CI: 6.3, 8.0) in the 221 patients receiving panitumumab plus FOLFOX versus the median PFS of 8.8 months (95% CI: 7.7, 9.4) in the 219 patients who received FOLFOX alone (HR = 1.29, 95% CI: 1.04, 1.62). Median OS was 15.5 months (95% CI: 13.1, 17.6) in patients receiving panitumumab plus FOLFOX versus the median OS of 19.3 months (95% CI: 16.5, 21.8) in patients who received FOLFOX alone (HR = 1.24, 95% CI: 0.98, 1.57).

An exploratory analysis of OS with updated information based on events in 82% of patients with wild-type KRAS mCRC estimated the treatment effect of Vectibix plus FOLFOX compared with FOLFOX alone. Median OS among 325 patients with wild type KRAS mCRC who received Vectibix plus FOLFOX was 23.8 months (95% CI: 20.0, 27.7) versus 19.4 months (95% CI: 17.4, 22.6) among 331 patients who received FOLFOX-alone (HR = 0.83, 95% CI: 0.70, 0.98).

therascreen KRAS test

Highly robust and standardized workflow for reproducible results —

  • The therascreen KRAS RGQ PCR Kit meets the requirements of the ERBITUX and Vectibix drug labels
  • Test results are comparable and reproducible from day to day, from operator to operator

Highly sensitive and specific PCR assay —

  • Detects the 7 KRAS mutations with proven clinical application
  • Highly sensitive, as it detects between 0.8 to 6.4% mutation in a background of wild-type DNA

Limit of detection for each mutation assay using FFPE cell line
Assay Limit of Detection (LOD)*
% of mutant detected in a wild-type DNA background
GLY12ALA – G12A 0.8
GLY12ASP – G12D 6.4
GLY12ARG – G12R 2.6
GLY12CYS – G12C 1.5
GLY12SER – G12S 5.6
GLY12VAL – G12V 1.6
GLY13ASP – G13D 6.4
* LOD defined as the dilution factor at which 95% of the test replicates (C95) for each mutation-positive sample

Comparison of the therascreen KRAS RGQ PCR test with conventional bi-directional DNA sequencing
  therascreen KRAS RGQ PCR Kit Bi-directional DNA sequencing
 Lower limit of detection Between 0.8 to 6.4% 15–25%
 Amplicon size ~100 bp 200 bp
 Procedure time < 8 hours 11 hours
 Complexity Low High
 Result output Objective Subjective


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The therascreen KRAS test is:

  • The first comprehensively validated FDA-approved test for KRAS mutation detection
  • Approved based on Phase III clinical trial data with ERBITUX and Vectibix of patients with KRAS wild-type tumor
  • A standardized assay for reproducible results
therascreen KRAS testing enjoys widespread coverage

Public and private payers endorse the value of KRAS testing with strong coverage policies for approved indications. Below is a sample of payers that have published positive coverage policies for KRAS testing.

Payers that have published positive coverage policies for KRAS testing
Sample listing
Aetna Blue Shield of CA
Anthem/Wellpoint Healthnet
BCBS AL Highmark BCBS
BCBS FL Humana
BCBS IL United Healthcare
BCBS MI Palmetto GBA (Medicare)
BCBS TX  

Public and private payers recognize the value of KRAS testing in determining the appropriateness of ERBITUX (cetuximab) and Vectibix (panitumumab) for a specific patient. The following payers require that a KRAS test be performed prior to prescribing.

Payers that require a KRAS test prior to prescribing
Private payers Medicare payers
Aetna CGS
Anthem/Wellpoint CGS Medicare
BCBS AL FCSO Medicare
BCBS FL Palmetto
Cigna WPS Medicare
Empire BCBS  
Horizon BCBS  
Humana  

To confirm individual patient benefits please call QIAGEN Reimbursement Solutions at: 877-7-MYQIAGEN (877-769-7424).

Representatives are available from 8:00 a.m. through 8:00 p.m. Eastern Time, Monday through Friday.

Important: Coverage information provided by QIAGEN is gathered from third-party sources and is presented for informational purposes only. Coverage for KRAS testing varies by patient and is subject to contracting, deductibles, and payment caps. This information does not guarantee payment and QIAGEN makes no warranty regarding this information, its completeness, accuracy, or timeliness. Payer policies are complex and change frequently, and providers are responsible for all decisions relating to coding and reimbursement submissions. QIAGEN recommends that you consult your payers, reimbursement specialists, and/or legal counsel regarding coding, coverage and reimbursement issues.


QIAGEN has a broad portfolio of companion diagnostic products in development.

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Resources

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External Websites
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Find out more about ERBITUX (cetuximab).
Find out more about Vectibix (panitumumab)
Clinical practice guidelines in oncology for patients with cancer.