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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Lab Industry Advisor Subscriptions Include
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
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
Global Markets: Local Joint Ventures Represent New Path into China Market
From - National Intelligence Report
While the strategy of targeting the China market is nothing new, the tactics have evolved. Recognizing the need for a…
Ordering Physicians: Oncologists Say Genomic Testing Is Overhyped
From - Laboratory Industry Report
When it comes to measuring Dx product effectiveness, few things speak louder than the attitudes of ordering physicians. With that in mind…
POC HCV RNA Testing Key to Achieving National Viral Elimination Goals
From - Diagnostic Testing & Emerging Technologies
The Xpert HCV Viral Load test (Cepheid, Sunnyvale, Calif.) for hepatitis C virus (HCV) has good accuracy for detecting viral RNA using whole blood from a finger stick…
Strategic Alliances, Partnerships & Collaborations Analysis – August 2017
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Mergers, Acquisitions & Asset Sales Analysis – August 2017
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New Fraud Takedown Shows that Coordinated Enforcement Remains Alive & Well under Trump
From - National Intelligence Report
Last year at this time, the Justice Department announced the results of a nationwide takedown involving "the most defendants charged and largest alleged loss amount in…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
After a relatively slow March and April, business has picked up noticeably in May, June and July with deal volume increasing across all…
Labs Can Provide Novel Support for Physicians Ordering Multigene Panels
From - Diagnostic Testing & Emerging Technologies
As the price of sequencing continues to drop and genomic testing in oncology continues to shift towards larger panels, physicians have self-reported difficulty in…
The 5 Things You Should Never Say to an OSHA Inspector
From - G2 Compliance Advisor
The way you handle an OSHA inspection can have as much impact on the outcome as the actual health and safety condition of your lab. More precisely…
FDA Approves First NGS Oncology Companion Dx for Multiple Therapies
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