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Test 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.

Highlights

In addition to single nucleotide variants and small insertions/deletions sequence variants, this test also identifies gene amplifications and fusions. Microsatellite instability status is also determined as a part of this test and is often clinically actionable for determining the efficacy of immunotherapy in solid tumors.

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

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test 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

NY State Approved

No

Forms

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