By Stephanie Murg, Managing Director, G2 Intelligence With the Food and Drug Administration poised to reverse its "enforcement discretion" and begin regulating laboratory-developed tests (LDTs) in the near future, industry groups are on the offensive. On August 4,...

By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Illumina (San Diego) selected the next round of startup companies for its genomics accelerator. This is the second, six-month cycle for the Illumina Accelerator, which seeks to aid entrepreneurs...

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...

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...

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...

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...

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...