) expanded its portfolio in Europe with CE Mark approvals of both
Xpert CT/NG and Xpert CT tests. The company expects to begin
shipments of the two tests shortly. The tests that will run on
Cepheid's flagship GeneXpert system are meant to detect and
differentiate between Chlamydia trachomatis ("CT") and Neisseria
gonorrhoeae ("NG"). These tests are capable of detecting results
within 90 minutes thus aiding the treatment process.
The company was expecting the approval of the CT/NG tests.
Cepheid had been working hard to speed up the clinical trial
process and as a result incurred higher costs in the most recent
quarter. The company also plans to make the test available in the
US in late 2012.
Gonorrhoeae and Chlamydia are sexually transmitted infections,
which are easily treated when detected early. These tests would
hugely benefit the patient population as the rate of reported
chlamydial infections doubled during the last decade, as per
estimates of the European Centers for Disease Control and
Prevention. Besides, the traditional method of detecting the
disease is time consuming, which makes the treatment
We are encouraged by Cepheid's focus on portfolio expansion that
should drive its top line in the forthcoming period. Although the
company is one of the leading players in the healthcare associated
infections ("HAI") segment, it is also looking at expanding in
non-HAI markets, which include critical infectious diseases,
women's health, virology and oncology and genetics. Several tests
are under development and the company is looking at launching new
tests in each of these markets in the 2013-2014 timeframe. This is
significant as the competitive landscape is tough with the presence
of players such as
Recent CE Mark approvals in Europe were followed by the US
approval of Cepheid's high-throughput automated molecular system,
GeneXpert Infinity-80. This is the latest addition to the GeneXpert
family and works on the GeneXpert module technology. The system,
initially cleared to be used with the Xpert Flu test, is scheduled
to hit the market on July 1, 2012.
We have a Neutral recommendation for Cepheid. The stock retains
a Zacks #3 Rank (Hold) in the short term.
CEPHEID INC (CPHD): Free Stock Analysis Report
GENOMIC HEALTH (GHDX): Free Stock Analysis
MYRIAD GENETICS (MYGN): Free Stock Analysis
To read this article on Zacks.com click here.