Diagnostic test kit maker Meridian Bioscience Inc. , recently announced the successful completion of beta trials for two of its illumigene molecular amplification tests. The assays are capable of detecting two of the most common sexually-transmitted infectious pathogens in the world viz. the Chlamydia trachomatis and the Neisseria gonorrhoeae.
The beta trial compared the performance of the illumigene assays with two other leading molecular platforms and the outcome demonstrated that the design criteria of both the assays are at par with industry standards. The illumigene test procedure became simpler when combined with the company’s new nucleic acid preparation device. The total test time taken on the illumipro-10 Integrated Incubator/Reader was roughly an hour.
The success of the beta trials represents an important achievement for Meridian’s U.S. Diagnostics segment’s product pipeline. The test reinforces its leadership position in rapid and accurate testing methods for infectious diseases.
Per the World Health Organization, approximately 4 million and 1 million people are infected by the Chlamydia trachomatis and the Neisseria gonorrhoeae, respectively, every year in the U.S. But the CDC reported only 1.2 million cases of Chlamydia in 2009. Given that more than half of sexually-transmitted diseases are still undiagnosed in the U.S., the assays have a huge scope to attract revenue opportunities.
The company plans to commence clinical trials of the two sexually-transmitted disease assays in the second quarter of fiscal 2013 and complete it by the third quarter. Further, it expects to launch the products in the U.S. market during the first half of fiscal 2014.
Meridian specializes in developing cost-effective diagnostic test kits for multiple serious and infectious diseases. The company in its fiscal 2013 guidance revealed that it expects illumigene molecular technology platform to leverage top-line growth along with Bioline products as well as its foodborne and H. pylori tests.
However, the company’s diagnostics business faces strong competition from Abbott Laboratories , Becton, Dickinson and Company . It expects the upcoming 2013 Medical Device tax to be a drag on its bottom line.
We currently have a Neutral recommendation on Meridien Bioscience, which carries a short-term Zacks #3 Rank (Hold rating).