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Luminex seeks FDA approval for Aries system and Aries HSV 1&2 assay

Luminex is seeking approval from the US Food and Drug Administration (FDA) for its Aries system and Aries HSV 1&2 assay.


The company has submitted 510(k) applications to the FDA for both products and is expecting FDA and CE-IVD mark approval by the end of this year.

Luminex president and CEO Homi Shamir said: "The FDA submission for the ARIES platform represents the culmination of years of development work.

"In Aries, we believe we have a truly differentiated product that will resonate quite favorably with laboratory customers."

Aries is a sample to answer system, which has been developed to enhance laboratory performance and efficiency.

It uses internal barcode scanning and other advanced features to reduce operator errors and two independent magazine modules each support from one to six cassettes, enabling both STAT and Batch testing.

According to the firm, simultaneous IVD and Laboratory Developed Tests (LDTs) can operate through a common Universal Assay Protocol.

The company is currently carrying out clinical trials for the Aries C. difficile Assay and the ARIES Group B Streptococcus (GBS) Assay and plans to begin clinical trials for additional Aries products prior to the end of the year.

Image: Luminex’s Aries System. Photo: courtesy of Luminex Corporation.