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
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
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