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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.

Method Name

Sequence Capture and Targeted Next-Generation Sequencing (NGS)

Reporting Name

MayoComplete Liquid Biopsy Panel

Specimen Type

Whole blood

Specimen 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 Rochester

CPT Code Information

81463

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.