Public-private partnership announces immediate 40 percent cost reduction for rapid TB test
PEPFAR, USAID, UNITAID and Bill & Melinda Gates Foundation have finalized an agreement to expand access to GeneXpert®, a molecular diagnostic system that provides a two-hour rapid diagnosis of TB, TB/HIV co-infection and drug-resistant TB.
WASHINGTON – August 6, 2012 – Today, the United States President's Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID), UNITAID, and the Bill & Melinda Gates Foundation announced an agreement that will significantly reduce the cost of a new, highly accurate, rapid diagnostic test for tuberculosis (TB) in 145 high-burden and developing countries.
Funds provided by this partnership will reduce the cost of Xpert MTB/RIF cartridges from $16.86 to $9.98, a price which will not increase until 2022. The effective date of this price decrease is August 6, 2012.
To date, the high unit cost of Xpert® MTB/RIF cartridges
produced by the medical device manufacturer Cepheid has proven a
barrier to their introduction and widespread use in low- and
middle-income countries. The new agreement will immediately
reduce the cost of cartridges used to diagnose TB by more than
40 percent.
In December 2010, the World Health
Organization (WHO) recommended the Cepheid product, known as
Xpert MTB/RIF assay, which is run on Cepheid's GeneXpert
platform. Until Cepheid developed the Xpert MTB/RIF assay, the
only method used in most laboratories in developing countries
was smear microscopy, a technique first developed in the 1880s
by the German bacteriologist Robert Koch that requires visual
detection of the TB bacterium under a microscope.
Smear
microscopy is particularly insensitive for diagnosing TB in
patients who are co-infected with HIV. It also does not help
clinicians detect the presence of drug-resistant strains of TB.
The limitations of traditional smear microscopy, along with the
cost and long delays to receive culture results, have limited
the ability to diagnose and treat TB and drug-resistant forms of
the disease.
Cepheid's GeneXpert is a molecular
diagnostic system that can detect TB disease in patients
co-infected with HIV and resistance to the antibiotic rifampicin
– a widely accepted indicator of the presence of
multi-drug resistant TB – in less than two hours. The
system also can be used outside of conventional laboratories
because it is self-contained and does not require specialized
training.
Because TB is the leading cause of death
among people living with HIV in Africa, greater access to this
test offers a significant advance in the capacity of health care
workers to diagnose TB quickly and help reduce TB transmission,
the development of TB disease, and premature TB deaths.
The
capacity of the Xpert MTB/RIF assay to yield a rapid and
accurate diagnosis has the potential to improve TB diagnosis and
treatment in rural clinical settings. A large percentage of
people with TB disease fail to start treatment promptly because
of the long wait for results of older conventional tests and the
need for them to return to the clinic, which may be far from
where they live. Using the GeneXpert system, clinics in poor and
rural settings can deliver rapid diagnosis and immediately start
patients on appropriate treatment, including
second-line
drugs in cases of drug-resistant.
Research suggests
that the incremental scale up of GeneXpert in countries with
high TB burdens could allow for the rapid diagnosis of 700,000
cases of TB disease and save health systems in low- and
middle-income countries more than U.S. $18 million in direct
health costs.
UNITAID
http://www.unitaid.eu/index.php?option=com_content&view=article&layout=edit&id=986
