US-based Meridian Bioscience has received CE mark approval for two new molecular diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).
The sixth and seventh assays on the illumigene platform, the CT and NG assays will use endocervical swabs, self-collected vaginal swabs, and female and male urine, allowing collection easy and non-invasive for physicians and patients.
Meridian Bioscience executive vice-president and Meridian Global Diagnostics president Mike Shaughnessy said: "Finally, there is a molecular platform in the market place that can decentralize testing that is typically done in core reference laboratories, and can be done so in a cost effective manner.
"Meridian expects these two new illumigene tests, along with the innovative M-Prep system, to be introduced to laboratories that haven’t had the opportunity previously to perform molecular testing, or are looking for improvements to their current testing platform."
The company also received CE mark approval for a sample preparation system, M-prep, which is developed to facilitate the isolation of Chlamydia and Gonorrhoeae from clinical samples.
Meridian Bioscience Europe will distribute all three products in the EMEA region, while the firm’s global distribution network will supply the products in additional international markets.
Meridian develops and markets diagnostic test kits, purified reagents and related products, in addition to offering biopharmaceutical enabling technologies.