Mobidiag Starts Clinical Trials for Lab-on-Chip Sepsis Detection

STMicroelectronics and Mobidiag have introduced a new lab-on-chip application for DNA-based detection of sepsis-causing bacteria, using a diagnostic panel from Mobidiag that runs on STMicroelectronics’s In-Check platform. Providing faster and more reliable results at a fraction of cost and complexity of conventional laboratory systems, the miniaturized compact solution enables early detection of disease, resulting in better treatment choices for patients and lower overall costs to the healthcare systems.

The In-Check platform hosts a pathogen panel developed by Mobidiag to identify ten sepsis-causing bacterial species as well as methicillin-resistant strains of Staphylococcus aureus from positive blood culture samples. The diagnostic panel has been designed to optimize the choice of antibiotic therapy in combination with results from Gram-staining, an empirical comparative method of differentiating bacterial species. As a result , highly accurate and rapid results from the STMicroelectronics/Mobidiag solution will reduce the risks of antibiotic misuse and help physicians select the right treatment as early as possible.

STMicroelectronics In-Check lab-on-chip platform amplifies clinically relevant DNA samples by PCR and has an integrated custom low-density microarray. Microreactors buried in the micro-electro-mechanical-system (MEMS) chip carry the mixture of sample and reagents, while on-chip heating elements perform the temperature cycling. Silicon’s low thermal capacity and the In-Check design features significantly reduce reaction times and costs, compared with standard laboratory equipment. The risks of cross-contamination inherent in conventional analysis methods are minimized, too, as the PCR and analysis is performed on chip in an encapsulated, self-contained unit.

The lab-on-chip interfaces to the Thermal Control System (TCS) that actuates, monitors, and adjusts the parameters of the reaction. The TCS unit comprises five control modules with independent thermal protocols and random access capability. Optical signal acquisition is performed by a dedicated portable reader and processed by STMicroelectronics’s specialized bioinformatics software, which can be installed on any PC and operates with Mobidiag’s clinical reporting user interface. This software package allows users to easily monitor and control the reaction processes, analyze the results, and generate reports compliant with MIAME (Minimum Information About a Microarray Experiment) standards for unambiguous interpretation of data from DNA tests.

After one year of joint development based on early prototypes, first units of In-Check lab-on-chips together with the control instruments are now shipping to Mobidiag for validation. Clinical trials are planned for early 2006, with the final product including validated controls, assay optimization, and diagnostic reporting software to be launched later next year.