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Mesa Biotech Point-of-Care Testing Platform Garners CE Mark

NEW YORK (GenomeWeb) — Mesa Biotech said today that its PCR testing platform for point-of-care infectious disease testing has obtained CE marking in the EU.

The first available test in the EU market will be the company's Flu A/Flu B test.

The Accula System is a palm-sized device that accepts disposable test cassettes. The cassette contains all necessary reagents for lysis and nucleic acid amplification. The system does not require as much power as a standard thermal cycler, and can be run using a rechargeable battery pack. Readout is performed on a lateral flow strip, with results available in about 30 minutes.

"The introduction of the Accula System and its Flu A/Flu B test as our first PCR assay in the European market is an important validation of our platform and a critical strategic milestone for Mesa Biotech," Mesa CEO and Founder Hong Cai said in a statement. "Our proprietary assay design enables rapid development of a portfolio of cassettes to test for human, agricultural, food pathogens, or genetic disease targets."

In December, Mesa announced a distribution deal with Sekisui Diagnostics, which will exclusively distribute the Accula system and flu test in the US and Canada pending regulatory clearance in those countries.