Micronics Inc, Redmond, Wash, a developer of in vitro diagnostic products and a wholly owned subsidiary of Sony Corp of America, has received FDA premarket notification (510(k)) clearance of its test for the detection of Shiga toxin-producing Escherichia coli (STEC).
The Micronics PanNAT STEC test is a qualitative, in vitro nucleic acid amplification assay performed in a disposable microfluidics-enabled cartridge that simultaneously detects and differentiates the stx1 and stx2 Shiga toxins and E. coli O157. The cartridge contains all the reagents required for the test, including a novel approach for integrated positive and negative quality controls. Sample, reagents, and waste are captured in the cartridge for ease of disposal.
Also cleared by FDA is the company’s PanNAT system, a compact, fully automated molecular diagnostic device with a user-friendly interface that processes the individual test cartridges. To initiate a test, users insert a patient sample tube into the PanNAT STEC test cartridge, and then slide the cartridge into the instrument. The instrument provides a sample-in to result-out answer in approximately 1 hour, with no sample preparation required.
The benchtop-sized instrument is portable and designed for use across a diverse range of centralized laboratories. In the event of short-term power loss, the instrument is battery-powered. The PanNAT STEC test is Micronics’ first molecular diagnostic test to receive FDA clearance as required for US sales and distribution. CE marking of the system and test are planned for European distribution.
“The ease of use of the PanNAT system and STEC test provide a needed solution for rapid testing,” says Karen Hedine, president and CEO of Micronics. “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.”
To learn more, visit Micronics.
Featured image: digitally-colorized scanning electron micrograph of Escherichia coli. Photo courtesy of the National Institute of Allergy and Infectious Diseases.