Ad Astra secures FDA 510(k) approval for QScout haematology analyser
08 Dec 2023
Diagnostic ReagentsClinical Result
QScout system is designed to provide rapid, point-of-care (POC) white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates the number and also provides the percentage of five types of mature WBCs and immature granulocytes
FDA approves Ad Astra’s QScout haematology analyser. (Credit: Louis Reed on Unsplash)
Ad Astra Diagnostics, a developer of rapid diagnostic systems, has received the US Food and Drug Administration (FDA) 510(k) approval for its QScout rapid-result haematology system.
The system is designed to provide rapid, point-of-care (POC) white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates the number.
It also provides the percentage of five types of mature WBCs and immature granulocytes.
Ad Astra said that its QScout system showed comparable performance to a central lab haematology analyser in a testing conducted at a central lab and several POC locations.
The testing was conducted in a cancer treatment centre, community health centre, emergency department, bedside with in-patients in the ICU, haematology-oncology wards, and a phlebotomy draw centre.
Ad Astra Diagnostics president and CEO Joy Parr Drach said: “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.
“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 said that its QScout system is the first haematology platform designed for simple and quicker operation at the point-of-care setting.
It provides caregivers with lab-grade, patient-side results, for screening health conditions such as infection, leukaemia, blood-related cancers, and allergies, among others.
The test requires whole blood of the patient, added to a QScout RLD test, which contains a dried reagent that stains cells.
After the test is inserted in the QScout Lab analyser, an optical system takes images, an algorithm identifies the cells in real-time, and the results are displayed within two minutes.
Ad Astra has received funding support from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for the project.
Ad Astra Diagnostics chief technology officer Jasper Pollard said: “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.
“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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