Vicky Pratt, PhD
Adjunct Clinical Professor of Medicine
Director, Pharmacogenomics and Molecular Genetics Laboratories
- Phone
- (317) 274-2810
- Address
-
R2 402
CPHR
IN
Indianapolis, IN - PubMed:
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Bio
Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics. Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute.
Dr. Pratt is the Past President of Association for Molecular Pathology. Dr. Pratt is also the Past Chair of the Genetics, Clinical Practice and the Program committees and is currently a member of the Economic Affairs committee for AMP. Dr. Pratt continues to serve on the Centers for Disease Control and Prevention (CDC) GeT-RM program for reference materials for Molecular Genetics, the National Academy of Medicine’s (formerly Institute of Medicine) Roundtable on Genomics and Precision Health, and the American Medical Association’s (AMA) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee.
Previously, Dr. Pratt is a former advisor of EurogenTest for genetic test validation. Additionally, she served on the Centers for Medicare and Medicaid Services Clinical Diagnostic Laboratory Tests Advisory Panel and the U.S. Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society for the Oversight of Genetic Testing and the Advisory Committee on Hereditary Disorders in Newborns and Children. She also participated in the preparation of the Morbidity and Mortality Weekly Report for Best Practices in Molecular Genetic Testing for the CDC and the National Academy of Medicine’s Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies.
Dr. Pratt has authored over 75 peer-reviewed manuscripts and book chapters. She is also an Associate Editor for the Journal of Molecular Diagnostics.
| Year | Degree | Institution |
|---|---|---|
| 1994 | PhD | Indiana University |
| 1988 | BS | Indiana University |
| 1987 | BA | University of Strasbourg |
My contribution to clinical science has centered on quality assurance of clinical genetic testing. I am a passionate advocate of quality laboratory testing and have written international guidelines for analytical validation. In order to ensure quality in genetic testing, reference materials are needed for clinical laboratories. Clinical laboratories often use genomic DNA samples, either from cell lines or residual de-identified patient material, as reference materials. This lack of reference materials hinders the ability of laboratories to develop and validate assays and perform necessary quality control. It also makes comparison of assays and standardization between laboratories difficult. I have been involved and led several efforts to characterize reference materials. Considering the complex nature of clinical testing and interpretation, and its impact on patient care, there is a practical need for standardizing clinical assays. Standardized test panels developed for clinical assays could also facilitate clinical implementation of genomic tests. Such standardized could enable physicians, researchers and other stakeholders to understand genetics test results without extensive scrutiny of the alleles included in the assay, and provide assurance that clinical laboratory panels include a minimum set of clinically relevant variants. The policy issues for the development, validation and clinical implementation of genetic biomarkers presents a number of challenges. First, there is significant uncertainty in the regulatory framework for biomarker tests. Second, there is concern over the adequacy of the current oversight of laboratories conducting biomarker testing. Third, there is a lack of alignment between the processes for regulatory and reimbursement decisions. All these challenges cause uncertainty and confusion among clinicians, patients, test manufacturers, and payers. I have been an active advocate for appropriate clinical testing and reimbursement.
I am responsible for the Clinical Pharmacogenomics and Molecular Genetics Laboratories at the Indiana University School of Medicine in the Department of Medical and Molecular Genetics in the Division of Diagnostic Genomics. I oversee the day-to-day running of the clinical laboratory from analytical validation to test report. I have over 20 years of experience in Molecular Genetic laboratory administration as having been the chief director of accredited clinical molecular genetic laboratories in large national reference laboratories as well as small academic laboratories.