Order Code 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.
Special Instructions
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 |
Reject Due To
Whole blood collected in tubes other than Streck Cell-Free DNA tubes | Reject |
Reference Values
An interpretive report will be provided.
Method Description
Blood samples are collected in Streck Cell-Free DNA blood collection tubes, and cell-free DNA (cfDNA) is isolated from double-spun plasma. Next-generation sequencing is performed on the cfDNA using the PGDx Elio Plasma Resolve chemistry.(Package insert: PGDx Elio Plasma Resolve. Person Genome Diagnostics Inc; 2020)
See Targeted Genes Interrogated by MayoComplete Liquid Biopsy Panel for details regarding genes interrogated by this test.
Day(s) Performed
Monday through Friday
Performing Laboratory
Mayo Clinic Laboratories in RochesterCPT Code Information
81463
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.