) has received clearance from the US Food and Drug Administration
(FDA) for its high-throughput automated molecular system GeneXpert
Infinity-80. GeneXpert Infinity-80 is a latest addition in the
GeneXpert System family of Cepheid and works on the GeneXpert
module technology. The system was initially cleared in combination
with the company's Xpert Flu test and is scheduled to hit the
market on July 1, 2012.
Similar to Cepheid's current Infinity-48 system, this new system
is claimed to generate over two thousand automated results a day.
In addition, the Infinity-80 is easy to use and requires less time
compared to the alternative solutions available in the market. The
company structured several modules of this mechanism to adopt any
Cepheid is currently focusing on those applications where rapid
molecular testing is necessary, such as identifying infectious
disease and cancer in the clinical molecular diagnostic market;
food, agricultural and environmental testing in the industrial
market; and identifying bio-terrorism agents in the biothreat
The company possesses a broad portfolio of tests that runs on
its GeneXpert system. It consists of SA Nasal Complete, MRSA
Surveillance, MRSA/SA Skin and Soft Tissue, MRSA/SA Blood Culture,
Clostridium difficile (C. diff) and Van A for VRE among others. In
July 2011, the company updated the entire GeneXpert System family,
including a new two-module GeneXpert, and introduced the GeneXpert
We believe that Cepheid is well positioned to improve its top
line based on an attractive test menu. We are impressed to note
that Cepheid's existing customers are increasing their use of the
GeneXpert test menu. While 70% of their US customers are using at
least two Xpert tests (up from 60% of a smaller US base in the
middle of 2010), 40% are using at least three tests (up from 30% in
The company is also working on launching tests in the areas of
women's health, virology and oncology and genetics. This is
significant as the competitive landscape becomes tough with the
presence of players such as
). However, Cepheid continues to remain cautious about the general
capital spending environment, especially in Europe.
We have a neutral recommendation for Cepheid. The stock retains
a Zacks #3 Rank (Hold) in the short term.
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