Diagnostic test kit maker
) won the approval of the U.S. Food and Drug Administration (FDA)
for its new
GAS (Group A Streptococcus) test. This test is used to accurately
detect acute GAS pharyngitis.
The most common disease caused by GAS, a bacterial infection, is
pharyngitis. Per census, acute pharyngitis results in almost 15
million visits to physicians every year in the U.S. Roughly 20% to
30% of children requiring medical treatment are detected with GAS
It has been found that regular laboratory testing such as throat
swab culture and rapid antigen testing produce faulty results in
roughly 1 out of every 10 cases. The advanced
GAS test is capable of accurately diagnosing pathogens in throat
samples using loop-mediated isothermal DNA amplification
Management believes that the sophisticated
GAS test will provide hospitals and laboratories a simple, highly
sensitive and economical test, helping them in early detection and
proper management of GAS. Further, the quick detection
of infectious pathogens will lower contamination risk, which in
turn will reduce overall healthcare expenses.
Meridian specializes in developing diagnostic test kits for
multiple serious and infectious diseases. The company's diagnostics
business faces strong competition from
Becton, Dickinson and Company
In December 2011, the company received FDA approval for the
GBS (Group B streptococcus) test on the
molecular test platform. Meridian is focused on introducing more
advanced and effective technologies to expand its diagnostic test
kits products portfolio.
Meridian in its recently released fiscal 2013 guidance revealed
that it expects
molecular technology platform to leverage top line growth along
with Bioline products as well as its foodborne and H. pylori tests.
However, the company expects the upcoming Medical Device tax from
2013 to be a drag on its bottom line. We currently have a
short-term Zacks #3 Rank (Hold rating) on the stock.
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