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Micronics Gets FDA Clearance for MDx System, E. Coli Test

NEW YORK (GenomeWeb) — Sony subsidiary Micronics announced today that its PanNAT microfluidic molecular diagnostics system and related test for Shiga toxin-producing Escherichia coli (STEC) have received US Food and Drug Administration clearance.

PanNAT is a fully automated PCR-based instrument designed to run single and multiplexed nucleic acid amplification cartridges, providing results within an hour without the need for sample preparation. Micronics noted that the battery powered, benchtop-sized platform is designed for use in a diverse range of centralized laboratories.

The STEC test cartridge simultaneously detects and differentiates the stx1 and stx2 Shiga toxins and E.coli O157.

Micronics said the STEC test is its first to receive FDA clearance. CE marking for both the test and PanNAT system is planned, the company added, although it provided no timeframe.

"Micronics believes that the PanNAT system is poised to take advantage of the expanding use of low to medium multiplex assays for timely diagnosis across a diverse group of customers, while also being responsive to the reimbursement environment," Micronics President Karen Hedine said in a statement.

Sony acquired Micronics in 2011.