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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
Cancer Screening Based on Unprovoked Venous Thromboembolism
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Theranos Receives First FDA Clearance, Inks Deal with Capital BlueCross
By Stephanie Murg, Managing Director, G2 Intelligence July is proving to be a month of milestones for Theranos (Palo Alto, Calif.). The company recently received its first FDA clearance—for its herpes simplex virus-1 (HSV-1) IgG assay—and announced a partnership...
White House Releases Precision Medicine Privacy Principles
By Kelly A. Briganti, Editorial Director, G2 Intelligence While promoting a personalized approach to medicine which involves more sharing of data, the Obama administration isn't neglecting the need to protect privacy when it comes to health information. The White...
Genomics Could Eclipse Other Largest Data Generators by 2025
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Data generated from genomics may exceed the largest generators of big data in other industries by 2025, according to a study published July 7 in PLOS Biology. Genomics' data requirements were...
Ignyta Strikes Clinical Trial Deal With UC San Francisco
By Ron Shinkman, Editor, Laboratory Industry Report Ignyta, the San Diego-based pharmaceutical and personal diagnostics firm, has entered into a collaboration with the University of California at San Francisco (UCSF) for a clinical trial regarding the treatment of...
CMS Releases New CLIA-Waived Tests, Billing Codes
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White House Releases Precision Medicine Privacy Principles
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CMS Offers Physicians and Providers Help Prepping for ICD-10
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Eurofins Continues Purchases With Emory Genetics Joint Venture
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Global bioanalytical testing giant Eurofins Scientific (Luxembourg) and Emory University's Emory Genetics Laboratory (EGL; Atlanta, Ga.) have entered into a joint venture. As part of the deal,...
Quest, Quintiles Launch Their Joint Venture
By Ron Shinkman, Editor, Laboratory Industry Report Quest Diagnostics and Quintiles have moved further in their business relationship, announcing a joint venture that will focus on clinical trials for the biopharmaceutical sector. The new Quest/Quintiles venture is...