MORRISVILLE, N.C. – Ad Astra Diagnostics (AAD), a pioneering force in rapid diagnostic systems, has announced a significant milestone with its QScout™ rapid-result hematology system. The system has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA), paving the way for faster and more accessible diagnostic information at the point of care. This innovative system provides crucial white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio (NLR), and detailed differential counts of five mature WBC types, along with immature granulocytes (IGs).
The QScout™ system distinguishes itself as the first hematology platform specifically engineered for rapid and straightforward operation directly at the point of care. This capability allows healthcare providers to obtain lab-quality results right at the patient’s side, facilitating quicker screening for a range of health conditions. These conditions include infections, leukemia and other blood cancers, allergies, and numerous other ailments. Notably, elevated levels of IGs have been identified as an early indicator for sepsis, potentially differentiating it earlier than conventional markers such as lactate and procalcitonin. Furthermore, NLR has emerged as an increasingly vital predictor of adverse health outcomes, gaining prominence during the recent pandemic. The QScout™ technology platform, protected by patents, was initially conceived to meet the demanding and unpredictable requirements of livestock care, highlighting its robustness and versatility.
“The speed at which QScout™ delivers vital metrics like WBC count with differential, IGs, and NLR is remarkable. It holds the promise of delivering life-saving insights to countless individuals, particularly in critical settings such as emergency rooms and intensive care units where time is of the essence,” stated Dr. Ted Glynn, Vice President, Medical Education and Research at Sparrow Health System. “Given that sepsis remains a leading cause of death globally, this regulatory achievement by Ad Astra Diagnostics is truly exciting. The capacity to provide these critical diagnostic measures in near real-time has the potential to transform how we deliver patient care.”
Joy Parr Drach, President & CEO of Ad Astra Diagnostics, also commented on this achievement: “Securing 510(k) clearance for the QScout™ platform is a landmark moment for the entire AAD team, and we anticipate this to be the first of many positive engagements with the FDA. Our vision in developing QScout™ was to empower and democratize rapid, point-of-care decision-making. We are confident that its user-friendly, robust, and maintenance-free design positions it as an invaluable asset across diverse healthcare environments.”
Operating the QScout™ test is remarkably simple. A whole blood sample is introduced to the QScout™ RLD test, which contains a pre-loaded reagent that stains the cells. Once the test is inserted into the QScout™ Lab analyzer, an advanced optical system captures images, and a sophisticated algorithm identifies the cells in real-time. The results are then displayed in approximately two minutes, significantly accelerating the diagnostic process.
Jasper Pollard, Chief Technology Officer at Ad Astra Diagnostics, elaborated on the technology: “QScout™ employs a state-of-the-art imaging-based system that overcomes the limitations associated with flow cytometry. This means cells are directly analyzed by an AI-trained system, rather than relying on indirect measurements such as light scatter or electrical resistance. With this 510(k) clearance, we are on the cusp of deploying our innovative diagnostic platform to various point-of-care settings, where faster results can lead to improved patient outcomes, and also to laboratories, where it can enhance operational efficiency.”
The performance of QScout™ RLD was rigorously evaluated against central lab hematology analyzers across a range of settings. These included central laboratories and multiple point-of-care locations such as cancer treatment centers, community health centers, emergency departments, ICUs, hematology-oncology units, and phlebotomy centers. This comprehensive testing underscores the reliability and versatility of the QScout™ system in diverse clinical environments.
This project has been partially funded by federal resources from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121C00089, as part of BARDA’s Host Based Diagnostics Program.
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.
About Ad Astra Diagnostics
Ad Astra Diagnostics, Inc. (AAD) is dedicated to transforming healthcare through rapid point-of-care diagnostics, enabling swift and informed health decisions. The company’s QScout™ system is engineered to enhance patient well-being, improve healthcare outcomes, and boost laboratory efficiency. The name “Ad Astra Diagnostics,” derived from the Latin phrase “to the stars,” reflects the company’s ambitious vision of democratizing access to advanced diagnostics, inspired by the precision and insights of astronomy.
Understanding Sepsis
Sepsis is defined as the body’s extreme and life-threatening response to an infection. It occurs when an infection triggers a systemic chain reaction throughout the body, requiring immediate medical intervention.
For further details, please visit QScoutRLD.com and AdAstraDx.com or contact 1-919-706-0695.
QScout™ and Information That Counts™ are registered trademarks of Ad Astra Diagnostics, Inc.
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SOURCE Ad Astra Diagnostics, Inc.
