Liquid Biopsy Assays

Author: David J. Moffa, PhD, BCLD
Reviewer: Laurie Bjerklie, MA, MLS(ASCP)CM
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Continuing Education Credits

P.A.C.E.® Contact Hours: 1 hour(s)

Florida Board of Clinical Laboratory Science CE Credit Hours

Florida Board of Clinical Laboratory Science CE - General (Molecular Pathology): 1 hour(s)

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Liquid biopsy is a rapidly advancing field with a growing number of companies involved in the development of these assays for the diagnosis and stratification of cancer patients. Because liquid biopsy can potentially provide a comprehensive, real-time assessment of the whole tumor burden for an individual patient, many experts believe it has the potential to replace the standard tissue biopsy. This course will discuss the primary molecular biomarkers detected in blood via liquid biopsy assay, including circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and exosomes.

Objectives

  • Define liquid biopsy testing and review its history.
  • Compare tissue biopsy with liquid biopsy and discuss their advantages and limitations.
  • Define the clinical significance of circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and exosomes.
  • Relate the relationship of CTCs and ctDNA in metastatic disease and their potential use in personalized medicine and personalized cancer therapies.
  • Describe the technologies involved in liquid biopsy testing and some leading commercial methods.

Course Outline

  • Definition and History of Liquid Biopsy Testing
    • Liquid Biopsy: Definition
    • The History of Liquid Biopsy Assays
    • Which statement correctly identifies liquid biopsy testing?
  • Tissue versus Liquid Biopsies: Advantages and Limitations
    • Tissue Biopsies
    • Primary Molecular Biomarkers Detected by Liquid Biopsy Assay
    • The Advantages and Limitations of Liquid Biopsies
    • True or False: For cancer patients, the tissue biopsy is a standard procedure used to pinpoint a cancer’s mutations and degree of malignancy.
    • When compared to tissue biopsy, what is one advantage of a liquid biopsy?
  • Circulating Tumor Cells (CTCs)
    • Circulating Tumor Cells (CTCs): Definition and Clinical Significance
    • True or False: Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream.
    • In patients with metastatic disease, CTCs are typically found in frequencies of what order of CTC per mL of whole blood?
  • Circulating Tumor DNA (ctDNA)
    • Circulating Tumor DNA (ctDNA): Definition and Clinical Significance
    • Which of the following statements is true for circulating tumor DNA (ctDNA)?
  • Exosomes
    • Exosomes: Definition and Clinical Significance
    • True or False: Exosomes are cell-derived vesicles in body fluids that play a key role in coagulation and are known to be released from tumors into the blood.
    • Which of the following statements is accurate regarding the clinical significance and importance of exosomes?
  • Liquid Biopsy and Personalized Medicine
    • Personalized Medicine
    • Liquid Biopsy and Personalized Medicine
    • True or False: Comprehensive medicine employs an individual’s genetic profile, protein makeup, and environment to prevent, diagnose, and treat disease.
  • Liquid Biopsy Technology Overview: Commercial Methods
    • Liquid Biopsy Technology Overview
    • With regard to the steps involved when performing a typical liquid biopsy assay, which of the following statements is incorrect?
    • The CELLSEARCH® CTC Test
    • The CELLSEARCH® CTC Test: Reports and Interpretation
    • Which statement is incorrect when describing the CELLSEARCH® CTC liquid biopsy test?
    • A CELLSEARCH® Test result for a metastatic breast cancer (mBC) patient was reported as eight (8) CTCs. How would this result be interpreted?
    • The test results of the CELLSEARCH® Test are reported as CTC levels that indicate a favorable versus unfavorable prognosis for certain metastatic cancers. Which of the following selections would be considered a favorable result for an individual with metastatic colorectal cancer (mCRC)?
    • The cobas® EGFR Mutation Test v2
    • True or False: The cobas® EGFR Mutation Test v2 has been approved by the FDA to detect EGFR mutations in non-small cell lung cancer (NSCLC) patients, as an aid in selecting therapy with an EGFR tyrosine kinase inhibitor (TKI).
    • Exosome Diagnostics ExoDx™ Lung(ALK)
    • What is isolated and analyzed by the ExoDx™ Lung(ALK) test and detects EML4-ALK fusion transcripts in the plasma of lung cancer patients?
    • True or False: The ExoDx™ Lung(ALK) test is an exosome-based clinical liquid biopsy assay, designed to identify the EGFR-ALK gene fusion which can predict response to ALK inhibitor therapies.
    • What is the exoRNeasy system used in the ExoDx™ Lung(ALK) test?
  • The Future of Liquid Biopsy Testing
    • The Future of the Liquid Biopsy Test
    • The Future of Liquid Biopsy Test, continued
    • Which statement is incorrect?
  • References
    • References

Additional Information

Level of Instruction: Beginner
Intended Audience: Medical laboratory scientists and technicians. This course is also appropriate for medical laboratory science students and pathology residents.
Author Information: David J. Moffa, PhD, BCLD has over 30 years of experience in the healthcare industry as an executive manager, clinical laboratory director, and medical laboratory scientist. He is currently a technical consultant for Kentmere Healthcare, Wilmington, DE, and until his retirement, was the Regional Director for LabCorp, Inc. He holds a PhD in medical biochemistry from the School of Medicine at West Virginia University.
Reviewer Information: Laurie Bjerklie, MA, MLS(ASCP)CM is currently an Education Developer for MediaLab and LabCE. She earned a B.S. in Medical Laboratory Science from the University of North Dakota and an M.A. in Curriculum and Instruction from Saint Xavier University. She has over 15 years of experience in higher education and has held program director and faculty positions in both MLT and MLS programs.
Course Description: Liquid biopsy is a rapidly advancing field with a growing number of companies involved in the development of these assays for the diagnosis and stratification of cancer patients. Because liquid biopsy can potentially provide a comprehensive, real-time assessment of the whole tumor burden for an individual patient, many experts believe it has the potential to replace the standard tissue biopsy. This course will discuss the primary molecular biomarkers detected in blood via liquid biopsy assay, including circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and exosomes.