Reimbursement for Molecular Tests – The Controversy Continues
By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing In an October 30, 2013, letter to Marilyn Tavenner at the Centers for Medicare...
View ArticleFDA orders 23andMe to cease and desist—is this the beginning of the end for...
By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing In a letter dated November 22, 2013, the Food and Drug Administration (FDA) ordered...
View ArticlePatients-in-Waiting—an Unintended Consequence of Genetic Screening
By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing A recent article in The Wall Street Journal (WSJ) drew attention to a little-known...
View ArticleIOM Discusses Challenges Associated with Using Genomic Sequencing for...
By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing On February 3, 2014, I had the privilege of attending an Institute of Medicine...
View ArticleIs Gene Editing the Future of Gene Therapy?
By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing As reported this week in the New England Journal of Medicine, researchers at the...
View ArticleReal-Life Implications for Misinterpretation of Direct-to-Consumer Genetic...
By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program Hayes has commented several times on this page regarding the potential negative implications of...
View ArticleOpening the Pandora’s Box of Genetic Information
By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program It is an exciting time to be working in genetics. The Human Genome Project took 15 years and $3 billion...
View ArticleMore Information to Consider About Genetics and Breast Cancer
Deciding who should be screened for the BRCA1 and BRCA2 gene variants that increase the risk of breast and ovarian cancer became a bit more complicated recently after Dr. Mary-Claire King, the...
View ArticleMaking Tough Choices
In a New York Times op-ed piece, Angelina Jolie once again opens up about the tough choices she’s had to make since learning she carries a variant in the BRCA1 gene, one of the genes associated with...
View ArticleNew Cancer Diagnostic Test Enters the Market
The field of pharmacogenomics, the study of how genes affect an individual’s response to medications, continues to move full speed ahead, especially in oncology. As investigators learn more about the...
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