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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
Metabolomic Markers Improve Cardiovascular Risk Prediction
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Sequencing Rapidly Emerging for Epidemiology, Outbreak Control
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Evidence Needed for Cost-Effectiveness of Sequencing
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High-Res Sequencing Data Differentiates Outbreak Clusters
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At Lab Revolution Conference, a Peek Inside Quest’s ‘Lab of the Future’
By Stephanie Murg, Managing Director, G2 Intelligence What does the lab of the future look like? This question was addressed by a broad range of experts at G2 Intelligence’s Lab Revolution 2015 conference, held March 11-13 in Orlando, Florida. Among the speakers...
Coverage for Electron Microscopy Left to MACs
By Christopher P. Young, Editor, G2 Compliance Advisor The Centers for Medicare and Medicaid Services (CMS) has removed the national coverage determination (NCD) for electron microscopy (EM) from the Medicare National Coverage Determinations Internet only manual...
FDA, AACR and ASCO Seeking to Harmonize Companion Diagnostics for Cancer Treatments
By Kelly A. Briganti, Editorial Director, G2 Intelligence Concerned that cancer patients may not receive "optimal care" when there are "multiple targeted therapy-companion diagnostic pairs," the U.S. Food and Drug Administration (FDA), American Association for...
Quest Strikes Deal With Personalis on Pediatric Exome Testing
By Ron Shinkman, Editor, Laboratory Industry Report Quest Diagnostics has teamed with the California-based testing firm Personalis to provide a whole exome sequencing product to detect rare genetic disorders among pediatric patients. The product, known as Neurome,...
Online Marketing of Personalized Oncology Services May Be Misleading
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Online marketing of personalized cancer tests and services frequently overemphasize their reported benefits, neglect to disclose their limitations, and promote genetic tests that do not have...
HHS Declares Enterovirus D68 Significant Potential for Public Health Emergency
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence The U.S. Department of Health and Human Services Secretary issued a notice declaring the enterovirus D68 (EV-D68) poses a “significant potential for a public health emergency that has a significant...