FDA Takes Shot Across the Bow with LDT Rulemaking
The FDA has issued proposed LDT rulemaking. Laboratories have an opportunity to make comments before it becomes official.
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Search Results for: compliance
Parallel Test Offers ‘Profound’ Benefits Over Serial Testing
A parallel test developed by Karius aims to improve treatment for serious diseases by diagnosing infections more rapidly and effectively.
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Sepsis Diagnosis Gets Point-of-Care Solution
Steripath delivers critical time savings for sepsis diagnosis, improving patient outcomes and providing cost efficiencies.
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C. Diff Has a Surprising Origin Story
Hospital-onset infections still occur—the most common caused by C. diff, the culprit in almost half a million infections yearly in the U.S.
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New Day Diagnostics Acquisition Agreement of Epigenomics AG Assets Gets Approved
New Day Diagnostics announced that the extraordinary general meeting of Epigenomics AG approved the acquisition agreement.
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