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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.
Could AI Reduce CT Scans in Cancer Detection and Assessment?
A new AI method developed by the National Cancer Institute could produce results similar to regular CT scans, but without exposing patients to radiation.
FDA Resumes Pre-Submission Requests for Non-COVID-19 IVD Tests
Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.