Test Catalog

Test Id : MCLBP

MayoComplete Liquid Biopsy Panel, Next-Generation Sequencing, Cell-Free DNA

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Provides information that may help with selection of the correct genetic test or proper submission of the test request

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.

 

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Sequence Capture and Targeted Next-Generation Sequencing (NGS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

MayoComplete Liquid Biopsy Panel

Aliases
Lists additional common names for a test, as an aid in searching

Cancer NGS Panel

Cell free panel

Cancer Panel

Cell free DNA

cfDNA

Comprehensive Genomic Profiling

Copy Number Variant

Fusion

Fusion Panel

Gene Amplification

Gene Fusion

Gene Rearrangement

Liquid Biopsy

Mayo Clinic Liquid Biopsy Panel

MCLBP

Microsatellite Instability

MSI

Next Gen Sequencing Test

NGS

Oncology Panel

Rearrangement

Sequence variant

Single Nucleotide Variant

Cancer Gene Panel

Pan Cancer

Mayo Complete

Specimen Type
Describes the specimen type validated for testing

Whole blood

Ordering Guidance

This test is not a prenatal screening test. For prenatal screening, consider QUAD1 / Quad Screen (Second Trimester) Maternal, Serum.

Shipping Instructions

1. Specimens should be transported at ambient or refrigerated (4 degrees 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.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
MG143 MCLBP Reason for Referral

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

One 10-mL Streck tube

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Whole blood collected in tubes other than Streck Cell-Free DNA tubes Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Whole blood Ambient (preferred) 7 days Streck Black/Tan top
Refrigerated 7 days Streck Black/Tan top

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Provides information that may help with selection of the correct genetic test or proper submission of the test request

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.

 

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.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 as a way to access genetic mutations of somatic tumors without a tissue biopsy.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Test results should be interpreted in the context of clinical, tumor sampling, histopathological, and other laboratory data. If results obtained do not match other clinical or laboratory findings, contact the laboratory for discussion by calling 800-533-1710. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.

 

Patients with a negative test result may still harbor a genomic alteration. Testing of a tissue specimen for mutations should be considered for patients who have a negative result with this test.

 

This test can be used to report gene amplifications but does not detect deletions.

 

This assay's limit of detection for detected mutations is influenced by the amount of cell-free DNA in the blood. This is a biological variable that cannot be controlled.

 

This test does not differentiate between somatic and germline alterations. Additional testing may be necessary to clarify the significance of results if there is a potential hereditary risk.

 

This test does not differentiate between tumor somatic alterations and CHIP (clonal hematopoiesis of indeterminate potential) mutations. Additional testing may be necessary to clarify the origin of mutations detected.

 

Rare alterations (ie, polymorphisms) may be present that could lead to false negative or false positive results.

 

The presence or absence of a variant or rearrangement may not be predictive of response to therapy in all patients.

Supportive Data

Performance Characteristics:

Limit of detection (LOD) for single nucleotide variants (SNV) is 0.5% for hotspot mutations, 1% for other SNV; 2.5% for deletion-insertions (delins), and 2 supporting reads for fusions. LOD for amplification is between 1.2- and 1.6-fold changes (2.4-3.2 copies) depending on specific genes and presence of sufficient single nucleotide polymorphisms (SNP) for allelic imbalance assessment. LOD for microsatellite instability (MSI) is 2% tumor DNA. MSI status is classified as MSI-High (MSI-H) detected (> or =2 sites unstable), and MSI-H not detected (<2 sites unstable).

 

Concordance for the detection of SNV and delins was 99%, gene amplifications 95%, fusions 100%, and MSI-H status 88% (with non-endometrial cases at 100%).

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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 Nov 15;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 Apr 13;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 Aug 1;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 Jul;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 Apr;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 Feb 1;5(2):173-180

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

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.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Whole blood: 2 weeks (if available); Extracted DNA: 3 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

81445

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
MCLBP MayoComplete Liquid Biopsy Panel 73977-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
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 MCLBP Reason for Referral 42349-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2022-11-04