NEW YORK – Nanosensor platform developer Nanomix said today that it has received CE marking for a diagnostic panel that aids in rapid identification of life-threatening infections, including sepsis and bacteremia, at the point of care.
The firm's newly CE marked S1 Assay Panel runs on its eLab analyzer and is used for the rapid, simultaneous detection and quantification of lactate, procalcitonin, and C-reactive protein from human plasma specimens. Lactate — commonly used as a disease biomarker during the initial evaluation of a patient suspected of sepsis — is neither specific nor sensitive enough to be used alone, the firm said. Its S1 Assay adds procalcitonin and C-reactive protein as biomarkers of inflammation and bacterial infection.
The test is intended to provide critical diagnostic information to physicians, allowing them to accelerate their clinical decision-making and improve upon it, and it enables receipt of laboratory-quality results in about 11 minutes during an initial patient evaluation, Nanomix said.
The Nanomix eLab analyzer, suitable for use within or outside traditional laboratory settings, is a handheld system that uses a microfluidic-based, single-use consumable and an electrochemical sensor for the automated, simultaneous detection of multiple analytes.
Emeryville, California-based Nanomix anticipates that in 2020, the S1 Assay panel and eLab instrument will be available through distribution within CE-regulated markets. The firm expects to submit the product for marketing clearance in 2020 to the US Food and Drug Administration, and it is evaluating a whole blood version of the platform.