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Ad Astra Diagnostics Severe Infection Analyzer Nabs 510(k) Clearance

NEW YORK – Ad Astra Diagnostics said Thursday that it nabbed US Food and Drug Administration 510(k) clearance for its rapid point-of-care hematology analyzer instrument that is used to identify markers of infections and cancers as well as help identify when infections will develop into sepsis or other severe diseases.

The Morrisville, North Carolina-based firm said its QScout RLD (rapid leukocyte differential) instrument is used to screen for infections, allergies, and blood-related cancers including leukemia. The instrument provides in about two minutes white blood cell counts, neutrophil-to-lymphocyte (NLR) ratios, counts of five varieties of mature white blood cells, and counts of immature granulocytes.

The firm said those measurements include immature granulocyte levels, which are an early marker of sepsis and can be used to differentiate sepsis up to 24 hours earlier than lactate and procalcitonin. Neutrophil-to-lymphocyte ratio is a prognostic marker for several diseases including COVID-19, it added.

"In developing QScout, we aim to enable and democratize rapid, point-of-care decision-making, and we are confident that its simple, easy-to-use, rugged, no maintenance design has the potential to be an invaluable tool in a variety of healthcare settings," Ad Astra President and CEO Joy Parr Drach said in a statement.

Ted Glynn, Sparrow Health Systems' VP of medical education and research, added that the QScout RLD instrument has potential to deliver lifesaving information in emergency and intensive care settings.

Ad Astra, which is a human healthcare-focused subsidiary of Advanced Animal Diagnostics, has been developing its hematology instrument in recent years with support from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to modify an analyzer the company had commercialized to reduce antimicrobial administration on farms.