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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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
Leveraging COVID-19 Testing Infrastructure Can Boost Diabetes Screening
A new study suggests that this is a viable idea, particularly in the context of diabetes screening in a Latinx community.
New Company Formed to Help Improve Access to Diagnostics
The creation of Global Access Diagnostics aims to expand affordable access to quality tests around the world.
OIG: Did Labs Do Enough Non-COVID-19 Testing during Pandemic?
The number of non-COVID-19 tests billed to Medicare during the pandemic has decreased compared to the six-month period before COVID-19.
Smart Inhalers May Enable Better Management of Respiratory Disorders
Inhalers and sensors that offer digital monitoring are beginning to gain FDA approval, and could solve usage issues of traditional products.
Genomic Biomarker Tests Endorsed for Early Prostate Cancer Management
Revised guidelines from the American Urological Association support limited use of the tests for certain prostate cancer patients.
FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD Tests
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.
Study Offers More Insight on Pandemic’s Disruption to Cancer Screening
New research led by the American Cancer Society shows decreases in cervical and breast cancer screening during the pandemic.
Laboratory Developed Test Regulatory Reform Moves Closer to Reality
Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.
LabCorp Gets First FDA Greenlight for SARS-CoV-2 Differentiation Test
For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.
Clinical Labs and Owner Charged in Alleged $2 Million UDT Scheme
Three labs, their owner, two lab marketing companies, a fourth lab, and a physician are accused of kickbacks, money laundering, and fraud.
