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clinical trial

The company in partnership with the University of Edinburgh recently completed a trial of the test involving 400 patients. 

 

 

The pilot study with the Mayo Clinic is the final step before SkylineDx commences a US trial next year for its molecular test for primary cutaneous melanoma. 

The partners plan to validate the accuracy, effectiveness, and clinical implications of Group K's MultiNostic liver function test, which is pending FDA clearance.

Beyond its HostDx Sepsis test, the firm is working on a test to detect and differentiate bacterial from viral infections in patients presenting with fever.

The firm is starting a trial that it anticipates will lead to an application for marketing clearance with the US Food and Drug Administration by next year.

The firm noted that its study showed strong performance data, including high sensitivity and high specificity, in providing results direct from blood.

During its earnings call this week, the liquid biopsy firm said it is planning a 10,000-patient trial to test its Lunar assay for colorectal cancer screening.

The British molecular diagnostics firm recently completely a redesign of its point-of-care system, called Q-POC, and is planning to seek a CE-IVD mark for the device later this year.

The BioFire FilmArray Pneumonia panel will be used to optimize clinical trial enrollment for an antibiotic to treat combat carbapenem-resistant A. baumannii infections.

The qPCR assay measures methylation of six genes and could help doctors identify aggressive vs indolent prostate cancer more accurately than PSA.

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