FDA Approves Molecular Diagnostics Platform for Smaller Labs

A latest-generation molecular diagnostics platform due to be released to the clinical laboratory market in the near future has already been cleared for use by the [U.S.] Food and Drug Administration (FDA).

The Luminex Corporation (Austin, TX, USA) has announced the receipt of FDA clearance (510k) for the company's new ARIES M1 System. Having been designed for lower throughput clinical labs, the ARIES M1 System is a fully integrated, sample to answer platform for performing real-time PCR assays.

The ARIES system utilizes the Luminex proprietary MultiCode real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies. MultiCode products, which are used for the early detection of infectious diseases and genetic-based conditions, are centered on the unique MultiCode bases, isoC and isoG. The synthetic isoC:isoG DNA base pair differs from the naturally occurring base pair in its hydrogen bonding pattern. As a result, the MultiCode bases, isoC and isoG, can only base pair with each other. This property enables site-specific incorporation of the isobases during amplification. The isoC and isoG MultiCode bases form the building blocks for Luminex’s next generation MultiCode assays for nucleic acid-based testing.

The ARIES instrument uses internal barcode scanning and other advanced features to minimize operator errors. Two independent modules each support from one to six cassettes, allowing for both STAT and batch testing. An integrated touch screen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse; thus maximizing valuable bench space. The low throughput ARIES M1 System provides one module with the ability to run one to six different assays according to the ARIES Universal Assay Protocol.

"In developing the ARIES family of systems, we listened closely to the needs of our customers and crafted these products to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory. We are now adding another system based on customer feedback, and in doing so, expanding our market reach," said Homi Shamir, president and CEO of Luminex. "Luminex now has the broadest offering of low-plex and high-plex sample to answer systems for clinical laboratories performing molecular diagnostic testing. And, with the acquisition of NSPH behind us, we can focus on continuing to move products in our pipeline towards commercialization and realizing the value in our newly acquired asset."

The new diagnostics system will be on display at the July 31-August 4, 2016, Annual Scientific Meeting & Clinical Lab Expo of the American Association for Clinical Chemistry in Philadelphia, PA, USA.

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