Diagnostics FDA

 News Release - November 16, 2023

Ad Astra Diagnostics receives 510(k) clearance of QScout(TM) hematology analyzer, the first to report measures of infection and severity at point-of-care

QScout™ RLD is the first test to report at point-of-care infection-fighting immature granulocytes (IGs), an early marker of sepsis, and neutrophil-to-lymphocyte ratio (NLR), a prognostic marker for several diseases including COVID-19

MORRISVILLE, N.C., Nov. 16, 2023 -- (Healthcare Sales & Marketing Network) -- Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its QScout™ rapid-result hematology system, which 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.

QScout™ is the first hematology platform designed for simple, fast operation at the point-of-care. It provides lab-grade, patient-side results to screen for health conditions including infection, leukemia and other blood-related cancers, allergies, and many more. Elevated levels of IGs are a known early marker of sepsis and have been shown to differentiate sepsis 24 hours earlier than commonly used measures like lactate and procalcitonin. Additionally, NLR is an increasingly important predictor of poor health outcomes, which gained greater use during the pandemic.

"By providing fast, 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."

"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 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, Chief Technology Officer, Ad Astra Diagnostics. "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."

The development of the patent-protected technology platform, QScout™, which has its origins in the rugged and unpredictable livestock-care setting, has been funded in part by a federal contract with the Biomedical Advanced Research and Development Authority's (BARDA) Division of Research, Innovation and Ventures for the earlier detection of severe infection, including sepsis in prehospital settings. 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.

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, bed-side with in-patients in the ICU, hematology-oncology wards, and a phlebotomy draw center.

About Ad Astra Diagnostics

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.

For more information, visit QScoutRLD.com, AdAstraDx.com or call 1-919-706-0695.

QScout™ and Information That Counts™ are trademarks of Ad Astra Diagnostics, Inc.

Source: Ad Astra Diagnostics

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.