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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Mid-Year Earnings: LabCorp Eclipses Quest As Biggest Lab Company
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CAP Helps Facilitate Cancer Data Sharing Partnership
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LabCorp Surpasses Quest as Largest Laboratory Company
By Ron Shinkman, Editor, Laboratory Industry Report With its second quarter earnings report, LabCorp has officially eclipsed Quest Diagnostics as the nation's largest laboratory company. LabCorp reported net income for the second quarter ending June 30 of $168.4...
AMP Offers Senate Committee Proposal for Regulation of Laboratory-Developed Tests
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,...
Illumina Selects Second Round of Genomics Companies for Accelerator
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...
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...