) disclosed that it gained the market authorization for its Xpert
MTB/RIF test from the U.S. Food and Drug Administration (FDA).
Following the authorization, the test will be commercially
available across the U.S. This comes as major positive news after
the molecular diagnostic company reported dismal second-quarter
About Xpert MTB/RIF
Cepheid's Xpert MTB/RIF test is designed for use on the company's
GeneXpert Systems and can be used for rapid molecular detection
complex (MTB-complex) DNA. Further, the test can also identify
rifampin-resistance associated mutations of the
gene in specimens where MTB-complex DNA is ascertained.
This will enable clinicians to recognize multidrug-resistant TB.
Patients suffering from multidrug-resistant TB required intensive
care and prolonged therapy. Unlike other standard laboratory
methods, the test results will be available rapidly, thereby,
improving timeliness and standards of patient care. Considering
that clinicians will have access to results in about 2 hours, the
Xpert MTB/RIF test should improve patient outcomes.
According to the company, the Xpert MTB/RIF is the most
innovative TB test to reach the market to date. Despite its
cutting edge technology, the test can be easily carried out
across multiple shifts in laboratories.
Despite the steady decline in TB rates in the U.S. compared with
early 1900s when the disease was the leading cause of death in
the country, brisk and accurate diagnosis of the disease remains
a challenge. Last year, 9,951 new incidences of TB were reported
in the U.S.
Since 1953, the prevalence of TB in the U.S. is at a minimum
level. However, the communicability and general symptoms of the
disease ensure the need for rapid detection. Furthermore, certain
groups and foreign-born individuals are disproportionately
affected by the disease in the U.S. The potentially fatal
multidrug-resistant TB can also spread during travel. Thus,
increasing awareness and brisk detection of the
multidrug-resistant TB is vital to eliminate TB in the U.S.
The overseas market remains largely underpenetrated. According to
World Health Organization estimates, about 8.7 new incidence of
TB were reported in 2011 across the globe. As TB still remains a
major cause of death in many countries, the potential market for
the Xpert MTB/RIF test appears to be highly underpenetrated. The
Xpert MTB/RIF test is already available in outside the U.S. and
in High Burden Developing Countries (HBDC).
Despite the gloomy outlook for 2013, Cepheid's pipeline is
encouraging. Strong demand for its innovative tests should
support growth going forward. The ongoing efforts on capacity
expansion should enable the company to meet the currently
assessed soaring market demand for its offerings.
Cepheid carries a Zacks Rank #3 (Hold). Other medical stocks such
IDEXX Laboratories Inc.
Globus Medical Inc.
) are likely to do well. These stocks carry a Zacks Rank #2
CEPHEID INC (CPHD): Free Stock Analysis
GLOBUS MEDICAL (GMED): Free Stock Analysis
IDEXX LABS INC (IDXX): Free Stock Analysis
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