Home
HelpTest ID: MCLBP MayoComplete Liquid Biopsy Panel, Next-Generation Sequencing, Cell-Free DNA
Ordering Guidance
This test is not a prenatal screening test. For prenatal screening, consider QUAD1 / Quad Screen (Second Trimester) Maternal, Serum.
Multiple oncology (cancer) gene panels are available. For more information see Hematology, Oncology, and Hereditary Test Selection Guide.
Shipping Instructions
1. Specimens should be transported at ambient or refrigerated (4° C) temperature.
2. Specimens are viable for 7 days when collected using the Streck Black/Tan Top Tube Kit.
Necessary Information
Paperwork (pathology report, oncology request form, or similar document) that indicates the cancer diagnosis must be provided. Testing may proceed without this information; however, it aids in providing a more thorough and accurate interpretation of results. Ordering providers are strongly encouraged to provide the information and send with the specimen.
Specimen Required
Supplies: Streck Black/Tan Top Tube Kit (T715)
Container/Tube: Streck Cell-Free DNA (cfDNA) blood collection kit
Specimen Volume: Two 10-mL Streck Cell-Free DNA blood collection tubes
Additional Information: Only blood collected in Streck Cell-Free DNA BCT tubes will be accepted for analysis. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.
Useful For
As an alternative to invasive tissue biopsies to assist in tumor profiling for diagnosis, predicting prognosis, and identifying targeted therapies for the treatment and management of patients with solid tumors
As an alternative to invasive tissue biopsies for assessment of microsatellite instability status
Genetics Test Information
This test uses targeted next-generation sequencing to determine microsatellite instability status and identify sequence variants, gene amplifications, and fusions translocation using circulating free DNA (cfDNA) in plasma. This test detects sequence variants in 33 genes, amplifications in 8 genes, and translocations in 5 genes.
Genes tested for single-nucleotide variants and deletions-insertions: AKT1, ALK, APC, ARID1A, ATM, BRAF, BRCA1, BRCA2, BRIP1, CCND1, CD274, CDH1, CSF1R, EGFR, ERBB2, EZH2, FGFR1, FGFR2, HRAS, KIT, KRAS, MET, MYC, NRAS, NTRK1, PDGFRA, PIK3CA, POLD1, POLE, RAF1, RET, ROS1,and TP53.
Genes tested for amplifications: CCND1, CD274, EGFR, ERBB2, FGFR2, KIT, MET, and MYC
Genes tested for translocations: ALK, FGFR2, NTRK1, RET, and ROS1
See Targeted Genes Interrogated by MayoComplete Liquid Biopsy Panel for details regarding genes interrogated by this test.
Note: This test is performed to evaluate for somatic (ie, tumor-specific) alterations within the genes listed. Although germline (ie, inherited) alterations may be detected, this test cannot distinguish between germline and somatic alterations with absolute certainty. Follow-up germline testing using whole blood can be performed for confirmation of suspected clinically relevant germline alterations. Germline testing should be performed along with genetic counseling.
Method Name
Sequence Capture and Targeted Next-Generation Sequencing (NGS)
Reporting Name
MayoComplete Liquid Biopsy PanelSpecimen Type
Whole bloodSpecimen Minimum Volume
One 10-mL Streck tube
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Whole blood | Ambient (preferred) | 7 days | Streck Black/Tan top |
| Refrigerated | 7 days | Streck Black/Tan top |
Clinical Information
Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the US Food and Drug Administration for treatment of solid tumor malignancies. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks. Microsatellite instability status is an increasingly important biomarker for determining effective immunotherapeutic treatment options for patients with solid tumors.
In addition to providing therapeutic insight, molecular profiling of tumors often provides prognostic and diagnostic information. Next-generation sequencing is an accurate, cost-effective method to identify variants across numerous genes known to be associated with response or resistance to specific targeted therapies. This test is intended for the use of cell-free DNA to access genetic mutations of somatic tumors without a tissue biopsy.
Reference Values
An interpretive report will be provided.
Interpretation
The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.
Clinical Reference
1. Schwaederle M, Husain H, Fanta PT, et al. Use of liquid biopsies in clinical oncology: Pilot experience in 168 patients. Clin Cancer Res. 2016;22(22):5497-5505
2. Kilgour E, Rothwell DG, Brady G, Dive C. Liquid biopsy-based biomarkers of treatment response and resistance. Cancer Cell. 2020;37(4):485-495
3. Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. Clin Cancer Res. 2019;25(15):4691-4700
4. Marcus L, Lemery SJ, Keegan P, Pazdur R. FDA approval summary: Pembrolizumab for the treatment of microsatellite instability-high solid tumors. Clin Cancer Res. 2019;25(13):3753-3758
5. Wan JCM, Massie C, Garcia-Corbacho J, et al. Liquid biopsies come of age: towards implementation of circulating tumour DNA. Nat Rev Cancer. 2017;17(4):223-238
6. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. JAMA Oncol. 2019;5(2):173-180
Day(s) Performed
Monday through Friday
Report Available
7 to 10 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81463
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| MCLBP | MayoComplete Liquid Biopsy Panel | 73977-1 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 614940 | Result Summary | 50397-9 |
| 614465 | Result | 82939-0 |
| 614466 | Interpretation | 69047-9 |
| 614467 | Additional Information | 48767-8 |
| 614468 | Specimen | 31208-2 |
| 614469 | Source | 31208-2 |
| 614470 | Method | 85069-3 |
| 614471 | Disclaimer | 62364-5 |
| 614472 | Released By | 18771-6 |
| MG143 | Reason for Referral - Cancer Type | 42349-1 |
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
mcl-moltechtestmenu; mcl-oncology