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Laboratory Data and Interoperability to be Focus of FDA Workshop
By Kelly A. Briganti, Editorial Director, G2 Intelligence Recognizing that laboratory tests "influence between 70 to 80 percent of clinical decisions," the Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the National Library of...
ACMG Adds Overused Genetic Tests to the Choosing Wisely Campaign
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The American College of Medical Genetics and Genomics (ACMG) has released a list of five commonly misordered genetic tests that patients and providers should discuss prior to ordering. The...
CAP Accreditation Checklist Update Addresses LDTs
By Kelly A. Briganti, Editorial Director, G2 Intelligence Proactively responding to the debate about laboratory developed tests (LDTs), the College of American Pathologists (CAP) has added new requirements relevant to LDTs to its accreditation checklists. On July...
Roche Seeks FDA Approval of Companion Lung Cancer Test
By Ron Shinkman, Editor, Laboratory Industry Report Pharmaceutical and testing giant Roche has submitted to the U.S. Food and Drug Administration a companion diagnostic for non-small cell lung cancer. The assay, known as the cobas EGFR mutation test, would be used...
AACC Calls for Accuracy, Transparency in Direct-to-Consumer Testing
By Stephanie Murg, Managing Director, G2 Intelligence With the market and media momentum of direct-to-consumer (DTC) testing showing no signs of slowing, the American Association for Clinical Chemistry (AACC; Washington, D.C.) issued a position statement on...