By Kelly A. Briganti, Editorial Director, G2 Intelligence
The U.S. Food and Drug Administration (FDA) released a 30-plus page report yesterday detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and exercise more robust oversight of laboratory developed tests (LDTs). An FDA Voice blog article announcing the release of the report describes the report as an illustration of…
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By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Direct-to-consumer startup DNA4Life (Mandeville, La.) is the latest recipient of a letter from the U.S. Food and Drug Administration (FDA) questioning the company's marketing of an unapproved genetic test. The test, which predicts response to 120 commonly prescribed medications based on analysis of 12 genes tied to drug metabolism, is being marketed as an unapproved medical device…
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 CareEvolve's outreach connectivity solutions exchange laboratory results and orders between the Laboratory Information System and provider's Electronic Medical Record (EMR/EHR) systems. In addition to industry leading interconnectivity, CareEvolve includes a cloud-based Patient Results Portal, Provider Portal and data analytic functionality. The CareEvolve solutions are currently interfaced with over 300 EMR products and transfer orders and results for more than 30,000 providers. For more information, visit www.careevolve.com or call 888-322-5222.
By Ron Shinkman, Editor, Laboratory Industry Report
Harmonyx, the Tennessee-based molecular laboratory, has struck a deal with pharmacy chain Rite Aid to sell its pharmacogenetic assays at its retail stores. Customers will be able to purchase the Harmonyx test at any Rite Aid store, except for those in New York State. Altogether, about 3,900 stores will be carrying the…
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By Kelly A. Briganti, Editorial Director, G2 Intelligence
Just in time for budget season, the Health Care Compliance Association has released a report demonstrating the resources health care organizations are devoting to their compliance programs. The report summarizes results of a survey regarding compensation for chief compliance officers and compliance staff but includes related information that is equally revealing…
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