Meridian Bioscience said this week that it has completed beta trials for two new Illumigene molecular amplification tests.
The two new assays, which are based on loop-mediated isothermal amplification, are designed to detect DNA from Chlamydia trachomatis and Neisseria gonorrhoeae from both swab and urine samples. The assays will also for the first time incorporate Meridian's nucleic acid preparation device, which further simplifies the test procedure, as it does not require excessive sample manipulations such as centrifugation or washing; and takes only five minutes to process a sample, Meridian said.
In the beta trial, Meridian tested the performance of the new assays against two undisclosed market-leading molecular platforms on a statistically significant cohort of symptomatic patients. The trials were successful and satisfied the design criteria for both assays, Meridian said. Total test time, from specimen to results, was approximately one hour on the Illumipro-10 Integrated Incubator/Reader.
Meridian said that it expects clinical trials in support of regulatory submission to begin later in its second fiscal quarter, which begins on Jan. 1, and completed later in its fiscal third quarter.