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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Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies
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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
Quest Expands into MRD Liquid Biopsy with Haystack Oncology Buy
The acquisition of the Johns Hopkins spin out and its liquid biopsy ctDNA test will significantly strengthen Quest’s oncology offerings.
Convicted Lab Owner Fails to Report to Prison
In addition to the usual FCA-related fare, an arrest warrant was issued for a convicted lab co-owner after he failed to show up for prison.
Pfizer Acquires Lucira Health for $36.4 Million in Bankruptcy Auction
Lucira has fallen on hard times since it secured the first FDA EUA for an at-home COVID-19 test in November 2020.
New Bill Would Guarantee Medicare Coverage of Newly Approved Breakthrough Devices
Congress brings back controversial Trump plan scrapped by the Biden administration.
Adapting to the New Normal: Navigating the Intersection of Healthcare and Economics in a Distributed Healthcare Delivery Model
In this session, learn key aspects of the data laboratories hold and potential uses for that data to strengthen laboratory financial health.
Sales and Marketing—Beyond COVID
Learn numerous proven field strategies and tactics to help laboratory sales reps achieve success in today's challenging environment.
CDC Calls Continued Rise in Cases of STIs “Alarming”
Health inequities and disrupted STI testing and care during the pandemic continued to contribute to a rise in cases in 2021.
Medicare Expands Coverage of Molecular Cancer Screening Tests
In terms of Medicare coverage, 2023 is shaping up to be a fruitful year—here are five of the most significant approvals so far.
Growth of Medical & Consumer Debt Poses New Challenges for Collections
Increasing medical and consumer debt is likely to get worse, meaning billing and collections may get even tougher for labs.
Hostile Regulatory Environment Further Chills Diagnostics Market
The biggest story in M&A dealmaking continues to be the deal that’s being undone—Illumina’s acquisition of GRAIL.
