Inside this Issue

Association for Molecular Pathology
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President's Message


Karen Mann, MD, PhD
Emory University
e-mail: kmann@emory.edu

Spring is here and, as I write this, I am coming up to my sixth month as the President of AMP. The time is flying by. AMP has been increasingly prominent with visits on Capital Hill, visits with the FDA, and increased mention in the media. The various Committees have been incredibly active pursuing their individual mandates and I would encourage you to read the Committee articles in the AMP Newsletter to see what they are doing. Also, if you have not already done so, visit the AMP website to check out its new design.  
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Gene Patents, What Now?
By Roger D. Klein, MD JD

On March 29, 2010 federal Judge Robert W. Sweet invalidated key claims of Myriad Genetics’ patents on the wild-type and mutated BRCA1 and BRCA2 gene sequences, as well as, associations between those sequences and a predisposition to breast and ovarian cancer. Under U.S. patent law, patents may be awarded on novel, non-obvious, and useful machines, manufactures, processes, and compositions of matter. Patents may not be awarded on products of nature, natural laws, and abstract ideas or mental processes.
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Laboratory Accreditation in Molecular Pathology
By Helen Fernandes, PhD

The accreditation process in Molecular Pathology can be challenging particularly to laboratories that implement Lab Developed Tests (LDTs). The three most important components of the molecular pathology checklist are Validation, Proficiency testing and Quality Control/ Quality Management. A seminar on Laboratory Accreditation sponsored by the College of American Pathologists (CAP) was presented on November 18, 2009. An overview of the accreditation process and discussion of measures for validation and quality control in molecular diagnostics was presented.  
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