Luminex Submits FDA 510(k) Application for Aries Products
Luminex has submitted FDA 510(k) applications for its Aries system molecular diagnostics platform and Aries herpes simplex virus 1&2 assay, the Austin, Texas, devicemaker announced Tuesday.
The company expects to receive U.S. and European marketing clearance before the end of the year, as well as launch the products during that timeframe.
Aries allows for the mixing and matching of assays in the same test run, claims president and CEO Homi Shamir. The product can be used for both STAT and batch testing.
The company is conducting clinical trials for the Aries C. difficile assay and the Aries Group B Streptococcusassay, with additional clinical trials planned for later this year.