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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
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...
Oncotype DX Use Consistent With Guidelines, Study Finds
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Oncotype DX assay (Genomic Health; Redwood City, Calif.), to assess a patient's risk of recurrence, was adopted quickly in clinical practice after Medicare's positive coverage decision,...
Castle Biosciences Study Reaffirms Efficacy of Predictive Melanoma Test
By Ron Shinkman, Editor, Laboratory Industry Report A new clinical study conducted in conjunction with the Texas-based Castle Biosciences, Inc. suggests that its molecular assay for melanoma patients can assist in determining whether their particular cancer will...