Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
First Half of Year Yields Earnings Growth for LabCorp, Quest
From - Laboratory Industry Report
LabCorp and Quest Diagnostics reported significant jumps in profitability during the second quarter of 2016 and throughout…
Industry Questions How Many Hospital Labs Will Be Reporting Under PAMA
From - G2 Compliance Advisor
When the Centers for Medicare & Medicaid Services (CMS) announced in mid-June the final rules governing the Protecting the…
House Committee Questions CDC on Capacity of Laboratory Response Network
From - National Intelligence Report
The U.S. House of Representatives Energy and Commerce Committee recently requested that the Centers for Disease Control and Prevention (CDC) provide information to the…
LabCorp Strikes Deal to Acquire Sequenom
From - Laboratory Industry Report
LabCorp has entered into another big deal, coming to terms to acquire neonatal specialty lab Sequenom for…
Theranos Announces Appeal of CMS Sanctions
From - G2 Compliance Advisor
Theranos has announced that it is appealing the Centers for Medicare & Medicaid's threatened sanctions. The announcement also indicated that…
FDA Considers Liquid Biopsies
From - National Intelligence Report
In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of…
Re-considering PSA Screening Strategies to Catch Aggressive Cases
From - Diagnostic Testing & Emerging Technologies
The number of new cases of metastatic prostate cancer climbed 72 percent from 2004 to 2013, according to a controversial new study published…
Laboratory Review of Genetic Test Orders Cuts Errors, Costs
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RNA Profiling May Aid in Fever Differentiation in Infants, Children
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Periodic Exome Reanalysis Yields New Diagnoses
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