FDA Clears Ad Astra’s QScout Hematology Analyzer

Ad Astra Diagnostics (AAD) U.S. Food and Drug Administration (FDA) 510(k) clearance for its QScout rapid-result hematology system, a product that provides fast, point-of-care white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates the number/percentage of five types of mature WBCs and immature granulocytes.
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QScout is touted as the first hematology platform designed for simple, fast operation at the point-of-care. It provides lab-grade, patient-side results that caregivers use to screen for various health conditions including infection, leukemia, and other blood-related cancers, allergies, and sepsis (the latter is a life-threatening medical emergency triggered by an infection). Elevated levels of IGs have been shown to differentiate sepsis earlier than commonly used measures like lactate and procalcitonin.¹ Additionally, NLR is an increasingly important predictor of poor health outcomes that gained greater use during the pandemic. Development of the patent-protected QScout technology platform began in the livestock care setting.
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“By quickly providing vital metrics such as a WBC count with differential, IGs, and NLR, QScout has the potential to deliver life-saving information to millions of people working in even the most urgent emergency and intensive care settings where every minute matters,” said Ted Glynn, M.D., vice president, Medical Education and Research, at Sparrow Health System. “Sepsis is the leading global killer, which is why I am excited to see this important regulatory achievement from our partners and colleagues at AAD. Delivering these critically informative diagnostic measures in close to real-time offers the potential to transform patient care.”
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“Achieving 510(k) clearance for the QScout platform is a momentous step for our AAD team, and we believe it will be the first of many positive interactions with the FDA,” Ad Astra President/CEO Joy Parr Drach said. “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.”
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To run the test, whole blood is added to a QScout RLD test, which contains a dried reagent that stains cells. When the test is inserted in the QScout Lab analyzer, an optical system takes images, and an algorithm identifies the cells in real time. Results are displayed in about two minutes.
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“QScout uses an imaging-based system not prone to the challenges of flow cytometry, which means that cells are examined directly by an AI-trained system instead of indirect measures like light scatter or electrical resistance,” Ad Astra Chief Technology Officer Jasper Pollard stated. “With this 510(k) clearance, we move closer to bringing our innovative diagnostic platform to various point-of-care settings, where faster results can improve health outcomes, and to labs, where it can improve efficiency and operations.”
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Testing to demonstrate equivalence of QScout RLD to a central lab hematology analyzer was performed at a central lab and at multiple point-of-care locations, which included a cancer treatment center, community health center, emergency department, bedside with in-patients in the ICU, hematology-oncology wards, and a phlebotomy draw center.
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This project has been funded in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, as part of BARDA’s Host Based Diagnostics Program.
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Morrisville, N.C.-based Ad Astra Diagnostics Inc. provides rapid point-of-care diagnostics to enable fast health decisions. The company’s QScout system was designed to improve health, well-being and lab efficiency. 

Reference
¹ Bhansaly P, Mehta S, Sharma N, Gupta E, Mehta S, Gupta S. Evaluation of Immature Granulocyte Count as the Earliest Biomarker for Sepsis. Indian J Crit Care Med 2022;26(2):216–223.