Ad Astra Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its point-of-care QScout rapid-result haematology system.
The results generated by the QScout system include white blood cell counts (WBCs) and neutrophil-to-lymphocyte ratio, as well as differentiate the number and per cent of five types of mature WBCs, along with immature granulocytes (IGs).
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These blood counts can be used to inform the diagnosis of various diseases, including infection, leukaemia, and other blood-related cancers. Furthermore, elevated levels of IGs can be used to differentiate sepsis.
The use of point-of-care diagnostics has increased following the Covid-19 pandemic. The global market for haematology analysers is forecasted to be worth approximately $2.1bn in 2030, as per a GlobalData market model.
The whole blood is added to QScout to run the test, which contains a dried reagent that stains cells. When the test is inserted in the QScout analyser, an optical system takes images, and an algorithm identifies the cells in real-time, with results displayed in about two minutes.
The QScout has been developed with seed funding from the US Biomedical Advanced Research and Development Authority (BARDA), which is a part of Administration for Strategic Preparedness and Response within the US Department of Health and Human Services.
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By GlobalDataIn August, BARDA awarded a contract to Satio to develop a new single-use and patch-based ebolavirus diagnostic. The diagnostic will integrate the patch-based blood collection device of Satio with the Institut Pasteur de Dakar’s sensitive ebolavirus immunoassay within a single device.
In other blood test development news, Jana Care raised $6m in the Series B financing round to complete the commercialisation of its self-administered blood tests for kidney and heart disease last month. In August, Nightingale Health introduced a remote blood collection kit for its medical research and clinical trial customers. The Nightingale kit and self-collection device would allow trial participants to draw their blood samples from a finger-prick.
