Clark A. Rundell
Clark A. Rundell, Ph.D., DABCC, FACB, is a clinical biochemist with more than
30 years of experience working in clinical diagnostics laboratories. He was
director of chemistry and molecular pathology for the Maine
Medical Center in Portland, Maine, and continues to serve part-time as assistant laboratory
director for the Cambridge Biomedical
Research Group, a clinical diagnostics
laboratory in Massachusetts.
Rundell has had a longstanding interest in clinical
laboratory quality control. He left the Maine Medical Center in 2000 and with
business partner Joan Gordon cofounded Maine
Molecular Quality Controls Inc.
where he is vice president for research. MMQCI develops, manufactures, and
markets synthetic quality controls for molecular diagnostics.
Rundell is a
member of the American Board of Clinical
Chemistry and the Centers for Disease
Control’s committee for development of quality control materials
for genetic testing. He is an adviser for the Clinical and Laboratory Standards
Institute’s document-in- development MM17-P titled Verification and
Validation of Multiplex Nucleic Acid Assays: Proposed Guideline and he
contributed to CLSI MM16-P, Use of External RNA Controls in Gene Expression
Assays: Proposed Guideline.
In addition to writing articles on quality
control in molecular diagnostics, Rundell has given presentations on the subject
at the CDC, the International Symposium on Reference Materials for Genetic
Testing, at recent national meetings of the European Society of Human Genetics,
the Australian Mutation Detection
Symposium, and the American Association
for Clinical Chemistry.
03/17/08 - Quality Goals for Molecular Tests
10/09/07 - Quality Control in Molecular Diagnostics
10/09/07 - A New Consideration for Some FDA In Vitro Diagnostic Device (IVD) Submissions
