Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
OIG Video Spotlights Physician Kickbacks
From - G2 Compliance Advisor
The U.S. Health and Human Services Office of Inspector General's (OIG's) concern about kickbacks to referral sources is…
Theranos Issues Thousands of Corrected or Voided Test Results
From - Laboratory Industry Report
While Theranos initially set out to change the laboratory sector with its Edison testing platform, to date it has mostly changed…
Luminex Acquires Nanosphere with Eye Towards Growth in Molecular Microbiology
From - Diagnostic Testing & Emerging Technologies
Luminex (Austin, Texas) announced this week it will acquire molecular microbiology firm Nanosphere (Northbrook, Ill.) in a cash deal valued at…
CDC Ups Online Tool’s Ability to Help ID Rare Pathogens
From - National Intelligence Report
Launched in 2013, MicrobeNet is a "virtual microbe library" established by the Centers for Disease Control and Prevention (CDC) that helps laboratorians identify less common bacteria and…
ID Genomics Receives $3 Million NIH Grant to Develop Antibiotics Screening Test
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Lab Startup Focused on Consumer Subscription Model
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PerkinElmer Continues to Make Global Transactions
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Abbott Moves to Terminate Alere Acquisition
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LabCorp, Quest Diagnostics Both Report Better-Than-Expected Quarterly Earnings
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ID Genomics Receives $3 Million NIH Grant to Develop Antibiotics Screening Test
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