In an attempt to strengthen its foothold in the virology market, molecular diagnostics corporation Cepheid (CPHD), together with the not-for-profit organization – Foundation for Innovative New Diagnostics (FIND), has reported the receipt of CE-IVD status for its in vitro diagnostic test – Xpert HIV-1 Viral Load, in Europe.
Acquired Immunodeficiency Syndrome, more commonly known as AIDS, is caused by a pathogen named Human Immunodeficiency Virus (HIV) which damages the body's immune system cells. Cepheid's Xpert HIV-1 Viral Load quantitatively measures the amount of active HIV present in the blood of a HIV positive patient.
Currently, this HIV viral load test is the standard measurement which is used in the diagnosis of HIV positive patients and helps in administering antiretroviral therapy. This test also determines the transmission risk associated with accidental or general exposure to blood. Cepheid expects to begin this test's shipping in Feb 2015.
According to the World Health Organization's estimates, at present 35 million people are affected with HIV/AIDS globally. Moreover, due to a weak immune system, HIV people are 26-31 times more prone to develop tuberculosis (TB) compared to those without the virus. What adds to the concern is that TB is a major cause of HIV-related deaths. This naturally raises alarm for the fast and effective detection of TB strains in HIV patients.
Management at Cepheid believes that the Xpert HIV-1 Viral Load test will adequately support the company's existing Xpert MTB/RIF test, which was designed especially for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA.
Notably, both these tests run on Cepheid's proprietary molecular diagnostic system – GeneXpert, also the world's leading molecular diagnostic platform.
We believe the receipt of CE-IVD mark for the Xpert HIV-1 Viral Load test will henceforth enable physicians in Europe to diagnose and provide appropriate treatment for patients affected with TB/HIV co-infections.
This announcement marks Cepheid's 8th product release in 2014, thereby expanding the company's menu of Xpert tests in the international market to 20.
In October, FIND, Cepheid, and Rutgers New Jersey Medical School reported that they would jointly develop a next-generation test for MTB called Xpert MTB/RIF Ultra for detecting patients with smear-negative TB, which is often associated with HIV co-infection.
We believe Cepheid's existing Xpert test menu along with those currently in the pipeline will enhance the company's financial position, ushering in more profitability over the coming quarters.
Zacks Rank
Currently, Cepheid carries a Zacks Rank #3 (Hold). Better-ranked medical instrument stocks include EnteroMedics Inc. (ETRM), Fluidigm Corporation (FLDM) and Inogen, Inc. (INGN). All these stocks sport a Zacks Rank #1 (Strong Buy).
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