Astronomical Advancement: Ad Astra Diagnostics Files 510(k) for Revolutionary QScout™ Hematology Analyzer

AAD, the innovative developer of rapid diagnostic systems, is taking a major step forward in its efforts to provide fast and accurate results for hematology testing.

The company has just submitted a 510(k) application to the FDA for QScout RLD, a revolutionary rapid-result hematology system that can report white blood cell count, neutrophil-to-lymphocyte ratio, and counts of six different white blood cell types quickly and accurately, in either fingerstick or venous blood samples.

QScout is an innovative hematology platform designed to quickly and easily measure signs of infection and disease at the point of care.

Funded by a federal contract with the Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research, Innovation and Ventures, QScout can detect severe infections, including sepsis, at an earlier stage than ever before by measuring the ratio of two white blood cell types (neutrophil-to-lymphocyte ratio) and counting immature granulocytes.

Sepsis is a life-threatening medical emergency that occurs when infection triggers a chain reaction throughout the body, and QScout’s technology can help clinicians quickly identify and treat this deadly condition.

Ad Astra Diagnostics is thrilled to announce their submission of a 510(k) application for the QScout system to the FDA, a major milestone in the development of this potentially revolutionary diagnostic platform.

The team is now looking forward to collaborating with the FDA for the regulatory review process, in the hope of obtaining clearance for the system to be used in both point of care and laboratory settings.

In the meantime, Ad Astra Diagnostics is also engaging in conversations with potential partners to ensure that the QScout system can be utilized to its full potential and reach more healthcare settings.

To unlock the secrets of your blood, simply add it to a QScout RLD (rapid leukocyte differential) test and watch it come alive! The dried reagent within the test stains the cells, and when placed in the QScout Lab analyzer, an optical system takes images and an algorithm identifies cells in real time. In just two minutes, you’ll have your results displayed before your eyes!

QScout RLD is revolutionizing the way healthcare professionals diagnose infection. By creating a tool that is both simple to use yet reliable enough to deliver accurate patient-side results, QScout RLD has the potential to provide greater access to quality diagnostics and potentially even save lives. As AAD’s Chief Scientific Officer and Co-Founder Rudy Rodriguez states, QScout RLD is a “quick, quantitative ‘scout’ for infection” that is sure to make a lasting impact in the medical field.

About Ad Astra Diagnostics

Ad Astra Diagnostics, Inc. (AAD) is dedicated to empowering fast health decisions with their revolutionary QScout™ point-of-care diagnostics. Their name, the Latin translation of “to the stars”, reflects their ambition to democratize diagnostic access, while honoring the legacy of astronomical techniques. With Ad Astra’s cutting-edge diagnostics, you can reach for the stars and make your health, well-being, and lab efficiency soar to new heights.

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