ADLM Says FDA’s LDT Rule Will Hinder Patient Care for the Underserved
The FDA’s new LDT rule could severely limit access to vital diagnostics, particularly in rural and marginalized communities, ADLM says.
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Search Results for: compliance
FDA Issues Letter of Support for Alpha-Synuclein Seed Amplification Assay
The FDA has endorsed the use of Amprion’s alpha-synuclein seed amplification assay for detection of neurodegenerative diseases.
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Ibex Unveils Advancements in AI Breast Cancer Diagnostics Platform
Ibex has introduced advancements to its AI-powered platform, enhancing breast cancer diagnostics, improving algorithm accuracy, and more.
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AMP Challenges FDA’s LDT Rule, Advocates for CLIA Modernization
AMP filed a lawsuit against the FDA for its new rule regulating LDTs as medical devices, advocating instead for modernizing CLIA regulations.
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Universal DX Initiates Clinical Trial for FDA Approval of Colorectal Cancer Test
Universal DX initiated a clinical trial for its colorectal cancer screening blood test with the goal of achieving FDA premarket approval.
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