AAD receives FDA clearance for QScout rapid-result hematology system
Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its QScout™ rapid-result hematology system. The system provides fast, point-of-care white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates the number and percent of five types of mature WBCs as well as immature granulocytes, according to a recent company announcement.
QScout™ is 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 health conditions including infection, leukemia, and other blood-related cancers, allergies, and many more, the company said.
Elevated levels of IGs have been shown to differentiate sepsis earlier than commonly used measures like lactate and procalcitonin1. 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 has its origins in the rugged and unpredictable livestock care setting.
"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, MD, Vice President, Medical Education and Research, 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."
Sepsis, the body's extreme response to infection, is a life-threatening medical emergency that happens when infection triggers a chain reaction throughout the body.
"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," said Joy Parr Drach, AAD's President & CEO. "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."
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.
"QScout™ uses a cutting-edge 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," said Jasper Pollard, AAD's Chief Technology Officer. "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."
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.
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, under contract number 75A50121C00089 as part of BARDA's Host Based Diagnostics Program.
Ad Astra Diagnostics, Inc. (AAD) 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. Ad Astra's name, the Latin translation of "to the stars", embodies the company's vision for democratizing diagnostic access and pays homage to techniques rooted in astronomy.
In a March 2023 article on the formation of AAD, Drach pointed out the importance of local support for the company.
“Our company started with a loan and grant from the North Carolina Biotechnology Center, and we received an HHS Biomedical Advanced Research and Development Authority contract to report the sepsis markers thanks to the accelerator at First Flight Venture Center,” said Drach. “It's the support of organizations like this that have made the creation of Ad Astra Diagnostics possible.”
1Bhansaly 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.