Mobile point-of-care diagnostics provider Nanomix has secured CE mark for its S1 Assay developed to assist in the rapid identification of serious, life-threatening infections such as sepsis and bacteremia.
The diagnostic panel can be used for rapid, simultaneous detection and quantification of lactate (LAC), procalcitonin (PCT), and C-reactive protein (CRP) in human plasma specimens.
Although LAC is generally used in the initial assessment of sepsis, its results are not particular and sensitive enough to be used alone.
By combining LAC, PCT, and CRP tests in a point-of-care format, the S1 Assay provides results right in the initial patient evaluation, and within 11 minutes.
Nanomix S1 Assay quickly provides critical diagnostic information to physicians
Nanomix assay quickly offers significant diagnostic information to help physicians advance and improve the clinical decision-making process.
The S1 Assay can be run on the Nanomix eLab analyser, a handheld system that uses a microfluidic-based and single-use consumable with an electrochemical sensor to automatically and simultaneously detect multiple analytes.
The eLab analyser is a simple mobile test system designed to offer laboratory-quality diagnostic results within minutes.
Besides Bluetooth and USB connectivity facilities, the eLab analyser features touchscreen graphical interface with a built-in barcode scanner. It can be used within or outside traditional laboratory settings.
The company is currently assessing a whole blood version of the S1test.
Nanomix president and CEO David Ludvigson said: “This novel assay increases the relevant information available to clinicians in the evaluation of serious infections, when urgent decision-making is required.
“The Nanomix S1 Assay is the first multiplex product to address the diagnosis of life-threatening infections at the initial point of care.”
Nanomix plans to commercialise the S1 Assay panel and eLab instrument in CE-regulated markets in 2020. In addition, the firm intends to submit the product to the US Food and Drug Administration in the same year.
