Diagnostic Assay Development

Molecular Diagnostics

The examination in Molecular Diagnostics tests the candidate’s Recall and Applied skills and is comprised of one part.

The examination tests mastery and knowledge of 1) genetics, 2) molecular biology, 3) hematology, 4) microbiology, 5) identity/HLA, 6) pharmacogenetics/biomarkers, 7) solid tumors, 8) techniques, and 9) management.

All questions are in multiple-choice format with one correct answer of options A-E. The molecular diagnostics examination has an average cumulative 5-year pass rate of 31%.

Molecular Diagnostics Exam (3 hours)

For Part A, the examinee is expected to perform calculations and problem solving related to:

• Principles
• Concepts
• Methodologies
• Usage of molecular biology technique as applied to clinical chemistry

Suggested Study Resources

Past examinees have identified the following activities as beneficial for preparing for this examination. These activities are NOT meant to be comprehensive guides but rather are presented to illustrate the broad nature of clinical molecular diagnostics. They are not endorsed by the ABCC.

TEXT BOOK RESOURCES

• Diagnostic Molecular Pathology in Practice: A Case-Based Approach. Iris Schrijver(Editor). Springer, New York, NY.
• Human Genetics and Genomics. Bruce R Korf and Mira B Irons. Wiley-Blackwell, Hoboken, NJ.
• Molecular Diagnostics: For the Clinical Laboratorian. William B Coleman and Gregory J Tsongalis (Editors). Humana Press, New York, NY.
• Molecular Pathology in Clinical Practice. Debra GB Leonard (Editor). Springer, New York, NY.
• Thompson & Thompson’s Genetics in Medicine. Robert Nussbaum, Roderick R McInnes and, Huntington F Willard (Editors). WB Saunders, Philadelphia, PA.
• Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Carl A Burtis, Edward R Ashwood, and David E Bruns (Editors), WB Saunders, Saint Louis, MO.

OTHER RESOURCES

• Clinical case studies, reports and reviews published in scientific journals specialized in molecular genetics, molecular diagnostics, microbiology, and oncology are a good source of information.
• American College of Medical Genetics and Genomics Standards and Guidelines for Clinical Genetics Laboratories.
• GeneTests and Gene Reviews
• COSMIC (Catalogue of Somatic Mutations in Cancer) database
• National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology
• Clinical and Laboratory Standards Institute Guidelines
• College of American Pathologists Laboratory Accreditation Checklists
• Dr. Roger L. Bertholf’s website presents PowerPoint lectures on various topics of clinical chemistry, including Statistics for Laboratorians.
• Lab Tests Online – American Association for Clinical Chemistry
• Various resources at the CDC Website, e.g., Morbidity and Mortality Weekly Report