Handheld Diagnostic Solutions Achieve Performance Requirements in POC Applications

An important milestone was achieved in the development of fully automated, handheld, rapid diagnostic test solutions for use at the point-of-care (POC).

One important target application for the technology is the measurement of cardiac Troponin-I levels in blood to assist in the rapid diagnosis of myocardial infarction. Troponin-I is typically found at elevated levels in patients who have suffered a heart attack. However, it is only present in the patient's blood in picomolar concentrations. In the past, detecting these extremely low concentrations has required costly time-consuming laboratory-based testing.

The milestone was the result of the integration of bioMérieux's (Marcy l'Etoile, France) assay technology and Philips' (Eindhoven, The Netherlands) Magnotech rapid diagnostic testing technology, into a disposable cartridge and handheld reader combination that achieves speed, sensitivity, and precision. The success represents one of the first POC multiassay solutions with the potential to achieve lab quality performance.

The achievement was realized within a year of the two companies signing a joint development agreement in January 2010 to develop handheld diagnostic solutions, and means that both companies will now go ahead with the development program.

Philips will further develop its prototype handheld reader into a fully engineered, rugged unit, while bioMérieux will continue the assay development. In addition, Philips will set up manufacturing facilities to be ready to produce the disposable cartridges for the 2013 commercial launch of the new solution.

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