While KRAS mutations are most commonly found in smokers, they can occur regardless of clinical or demographic characteristics12
While KRAS mutations are most commonly found in smokers, they can occur regardless of clinical or demographic characteristics12
Guidelines recommend testing for both actionable and emerging biomarkers (including KRAS) in patients with advanced NSCLC2,4,5
KRAS mutations often occur early and persist as the disease progresses13,14
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend molecular testing at diagnosis for eligible patients with advanced* NSCLC via a broad, panel-based approach6†‡
CAP/IASLC/AMP and ASCO Guidelines recommend testing for both actionable biomarkers and emerging biomarkers (eg, KRAS) utilizing either a comprehensive panel or targeted testing4,5
*Includes patients with advanced/metastatic NSCLC, but not locally advanced NSCLC.6
†It is recommended at this time that when feasible, molecular testing be performed via a broad, panel-based approach, most typically performed by NGS.6
‡The NCCN Guidelines® for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays.6
*It is recommended at this time that when feasible, molecular testing be performed via a
broad, panel-based approach, most typically performed by NGS.6
†The NCCN Guidelines® for NSCLC provide recommendations for individual
biomarkers that should be tested and recommend testing techniques but do not endorse any specific
commercially available biomarker assays.6
‡Includes patients with advanced/metastatic NSCLC, but not locally advanced
NSCLC.6
§Note: In June 2020, the FDA approved immunotherapy for unresectable or metastatic
TMB-high solid tumors.15
A broad panel uses less tissue than a series of single-gene tests, so additional tests can be run if needed2
Broad panel testing can be cost-effective based on the number of biomarkers requiring testing in NSCLC and may avoid the added cost and risk of rebiopsy2,16
Expanded-panel testing at diagnosis may take less time than consecutive single-gene tests in a process-of-elimination approach16
Expanded panel testing provides results for many biomarkers in one report rather than multiple different reports17
KRAS G12C is already included in most NGS panels and can also be detected by currently available PCR and Sanger sequencing methods.7-9,18
KRAS G12C results may already be in your report
Most NGS platforms already test for KRAS G12C. There are also many PCR platforms capable of KRAS G12C testing7-9,18
Tissue in NSCLC remains the gold standard—and liquid biopsy shows a high degree of concordance10,19
NGS (FFPE sample) | PCR (FFPE sample) | |
---|---|---|
Reliability* | 1%–10% sensitivity, 95%-100% specificity2,7,20 | 1%–5% sensitivity, 96%–100% specificity18,20-22 |
DNA/RNA Input | 10–1000 ng DNA/10–200 ng RNA7,20,23,24 | 5–300 ng DNA/50–1000 ng RNA20,21,25-27 |
Turnaround Time2,20,22 | 4–14 days† | 1–7 days |
Limitations |
|
*Includes whole genome and targeted NGS analyses and quantitative/real-time and digital PCR
analyses.
†CAP/IASLC/AMP Guidelines recommend a turnaround time of no more than 10
days.5
Image reproduced with permission from Pantel et al.30
One form of liquid biopsy consists of obtaining ctDNA from plasma, which can be used to identify genomic alterations5,30
Utilizing cfDNA in addition to tissue increased the number of patients identified to have a driver mutation by 48% ,† and patients were significantly more likely to receive the complete genotyping that is recommended by guidelines19‡
FDA-approved liquid biopsy tests are already available for some NSCLC biomarkers32
Both the CAP/IASLC/AMP guidelines and an IASLC consensus paper support the utility of a positive liquid biopsy result5,29
*Concordance and PPV for the other guideline-recommended biomarkers
was similarly high.19
†The number of patients identified to have driver mutation
increased from 60 to 89, including those with negative, not assessed, or
insufficient tissue results.19
‡The guideline-recommended biomarkers in this study included:
EGFR, ALK, ROS1, BRAF, RET, METex14 skipping, MET
amplification,
and ERBB2 (HER2). The number of patients who received complete
genotyping increased from 51 to 268 (P<0.0001).19
*FDA-approved targets included EGFR, ALK, ROS1, and BRAF.
Check with your current pathologist or lab to confirm KRAS G12C is already included in their panel for NSCLC. However, if testing needs to be sent out, see below for a list of some national reference labs that offer testing for KRAS G12C
Lab | Location | Website | Phone Number |
---|---|---|---|
ARUP LaboratoriesARUP Laboratories Salt Lake City, UT |
Salt Lake City, UT | https://www.aruplab.com | (800) 522-2787 |
https://www.aruplab.com | |||
BioceptBiocept San Diego, CA |
San Diego, CA | https://biocept.com | (888) 332-7729 |
https://biocept.com | |||
BiodesixBiodesix Boulder, CO |
Boulder, CO | https://www.biodesix.com | (866) 432-5930 |
https://www.biodesix.com | |||
Caris Life SciencesCaris Life Sciences Phoenix, AZ |
Phoenix, AZ | https://www.carislifesciences.com | (888) 979-8669 |
https://www.carislifesciences.com | |||
Circulogene TheranosticsCirculogene Theranostics Birmingham, AL |
Birmingham, AL | https://circulogene.com | (855) 614-7083 |
https://circulogene.com | |||
Foundation MedicineFoundation Medicine Cambridge, MA |
Cambridge, MA | https://www.foundationmedicine.com | (888) 988-3639 |
https://www.foundationmedicine.com | |||
GenPath DiagnosticsGenPath Diagnostics Elmwood Park, NJ |
Elmwood Park, NJ | https://www.genpathdiagnostics.com | (800) 627-1479 |
https://www.genpathdiagnostics.com | |||
Guardant HealthGuardant Health Redwood City, CA |
Redwood City, CA | https://guardanthealth.com | (855) 698-8887 |
https://guardanthealth.com | |||
LabCorp / Integrated Oncology / US LabsLabCorp / Integrated Oncology / US Labs Phoenix, AZ |
Phoenix, AZ | https://www.labcorp.com |
AZ: (800) 710-1800 CT/NY: (800) 447-5816 TN: (800) 874-8532 |
https://www.labcorp.com | |||
Mayo Clinic LaboratoriesMayo Clinic Laboratories Rochester, MN |
Rochester, MN | https://www.mayocliniclabs.com |
(800) 533-1710 or (507) 266-5700 |
https://www.mayocliniclabs.com | |||
NeoGenomics LaboratoriesNeoGenomics Laboratories Aliso Viejo, CA |
Aliso Viejo, CA | https://neogenomics.com/ | (866) 776-5907 (option 3) |
https://neogenomics.com/ | |||
Novogene Corporation Inc.Novogene Corporation Inc. Sacramento, CA |
Sacramento, CA | https://en.novogene.com | (916) 252-0068 |
https://en.novogene.com | |||
Paradigm Cancer DiagnosticsParadigm Cancer Diagnostics Phoenix, AZ |
Phoenix, AZ | https://www.paradigmdx.com | (844) 232-4719 |
https://www.paradigmdx.com | |||
PredicinePredicine Hayward, CA |
Hayward, CA | https://www.predicine.com | (650) 300-2188 |
https://www.predicine.com | |||
Quest DiagnosticsQuest Diagnostics Teterboro, NJ |
Teterboro, NJ | https://www.questdiagnostics.com | (866) 697-8378 |
https://www.questdiagnostics.com | |||
TempusTempus Chicago, IL |
Chicago, IL | https://www.tempus.com | (800) 739-4137 |
https://www.tempus.com | |||
TriCore Reference LaboratoriesTriCore Reference Laboratories Albuquerque, NM |
Albuquerque, NM | http://www.tricore.org/home |
(505) 938-8888 or (800) 245-3296 |
http://www.tricore.org/home |
The above is a list of facilities with high testing volume that are CLIA certified and accept external
samples. CLIA certification was validated using the CDC website, and acceptance of external samples was
confirmed by reviewing facility websites and/or contacting facilities directly. Amgen neither recommends
nor endorses, and may or may not have financial relationships with, any facility that appears on this
list. This list is not intended to be a comprehensive list nor as a referral to any lab listed. If you
would like to suggest a facility to be added to this list, please contact Amgen MedInfo at
800-77-AMGEN.
This information is current as of September 8, 2020. Amgen does not guarantee the accuracy of this
information, and it is up to the individual healthcare professional to conduct his/her own research.
Your MDT may include oncologists, pathologists, pulmonologists, nurse practitioners, physician assistants, nurse navigators, office staff, and others39,40
Consider using the upfront summary of your reporting template to document both actionable and emerging biomarkers11
Consider uniform and unambiguous nomenclature (ie, KRAS G12C)11
Consider recording patients’ biomarker status in your notes or their chart for ease of future reference33
Consider using a set location for reports for easy access by all members of the MDT11,33
ALK, anaplastic lymphoma kinase; AMP, Association for Molecular Pathology; ASCO, American Society of Clinical Oncology; BRAF, v-Raf murine sarcoma viral oncogene homolog B; CAP, College of American Pathologists; cfDNA, circulating free DNA; CLIA, Clinical Laboratory Improvement Amendments; CTC, circulating tumor cells; ctDNA, circulating tumor DNA; EGFR, epidermal growth factor receptor; EMR, electronic medical record; ERBB2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2; FFPE, formalin-fixed, paraffin-embedded; GGT, glycine; HER2, human epidermal growth factor receptor 2; IASLC, International Association for the Study of Lung Cancer; KRAS, Kirsten rat sarcoma; MET, mesenchymal epithelial transition; METex14, MET exon 14; mNSCLC, metastatic NSCLC; NCCN, National Comprehensive Cancer Network; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer; NTRK, neurotrophic-tropomyosin receptor kinase; PCR, polymerase chain reaction; PD-L1, programmed cell death ligand 1; PPV, positive predictive value; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1, receptor tyrosine kinase; TGT, cysteine; TMB, tumor mutational burden.