New England Journal of Medicine Study Shows New Molecular TB Test Could Offer Rapid and Effective Diagnosis in Developing Countries

Fast, accurate and easy-to-use TB test could revolutionize diagnosis of a disease that kills nearly two million people annually

GENEVA, September 1, 2010 - A study(1) published in The New England Journal of Medicine today reports
that a new molecular tuberculosis (TB) test, Xpert(R) MTB/RIF, provides
highly sensitive detection of tuberculosis and drug resistance in low
resource settings more easily and in significantly less time than any
current, widely used diagnostic. The study, conducted by the Foundation for
Innovative New Diagnostics (FIND), showed that the Xpert(R) MTB/RIF test
successfully identified 98% of all culture-confirmed TB cases, including over
90% of those with smear-negative disease. It also accurately detected
resistance to the powerful anti-TB drug rifampicin (RIF) in more than 97% of
patients, providing results in less than two hours.

The Xpert(R) MTB/RIF test is a cartridge-based, fully automated molecular
diagnostic test for TB co-developed by FIND and its partners Cepheid and the
University of Medicine and Dentistry of New Jersey (UMDNJ). The test uses the
Cepheid GeneXpert(R) system-a fully-automated technology platform based on
real-time polymerase chain reaction amplification with integrated sample
preparation. Development of the assay was also supported by the U.S. National
Institute of Allergy and Infectious Diseases (NIAID), Cepheid and the Bill &
Melinda Gates Foundation.

This public-private partnership effort successfully demonstrates that
combining the resources and expertise of diverse stakeholders, from
fundamental science through translational research and product development to
clinical evaluation, can lead to the rapid development of novel TB diagnostic
tools.

Although rare in developed countries, TB remains one of the world's
deadliest infectious diseases. TB kills approximately 1.8 million people each
year, mainly in developing countries, and drug-resistant TB is a growing
threat. Early detection of TB is crucial to stop the TB epidemic, because
undiagnosed and untreated patients with active TB-including drug-resistant
TB-can infect 10-15 other people each year.

"The search for faster and more effective means to diagnose TB, which is
the second greatest infectious killer of adults worldwide, is a top priority
for the global health community," said Dr Mario Raviglione, Director of the
World Health Organization's Stop TB Department. "Over the next few days, WHO
will convene independent experts to review the full evidence about the field
effectiveness of this novel technology and propose it to country programmes.
These results suggest that it has the potential to revolutionize TB care, and
WHO will treat it as a top priority."

The most widely used method of TB diagnosis, sputum smear microscopy, is
more than 125 years old and misses more than half of all TB cases. It cannot
detect drug resistance and is largely ineffective in patients with HIV
co-infection-a major driver of the global TB epidemic. At the same time, the
most sensitive tool available for detecting TB or drug resistance is culture
testing, which takes weeks to provide a result, is costly, requires capital
intensive equipment, highly trained personnel and the construction of
bio-safety facilities.

"The results of the study show that this innovative tool has the
potential to revolutionize TB care for our patients," said Dr L.S. Chauhan,
Manager of the National Tuberculosis Programme in India. "The new test
enables health workers in the field to give patients a reliable on-the-spot
diagnosis of TB and drug resistance during clinic visits, allowing for prompt
diagnosis and early initiation of appropriate treatment."

Although molecular amplification tests for TB have been licensed for
diagnostic use for over a decade, the Xpert(R) MTB/RIF test is the first in
its class specifically designed for use by relatively unskilled health
workers in endemic areas. Running the test requires little hands-on time and
minimal technical skills or laboratory facilities. As such, it has the
potential to be used outside reference laboratories, at local diagnostic
centres or clinics, where the need is greatest.

The Xpert(R) MTB/RIF test inactivates the TB bacteria in the sputum
sample, and requires no additional equipment, making it possible to
decentralize diagnosis and give rapid, accurate results to patients, without
the use of bio-safety facilities.

"Quick and accurate TB diagnosis is critical to break the chain of
disease transmission and prevent new TB infections," said Dr Giorgio
Roscigno, Chief Executive Officer of FIND, "and the results of this study
confirm that the Xpert(R) MTB/RIF test provides a faster, more accurate
result than the standard tests used today. Once WHO has issued a
recommendation on the use of the test, FIND will work with international
partners and national health programmes to accelerate global access to this
potentially lifesaving technology."

The study examined some 1,730 patients with suspected drug-sensitive or
multidrug-resistant (MDR) pulmonary tuberculosis across five trial sites in
Peru, Azerbaijan, South Africa and India between July 2008 and March 2009.
The Xpert(R) MTB/RIF test detected a greater fraction of all cases using a
single sample than did conventional solid culture, the current "gold
standard". In addition, the test was 99.2% specific, showing positive results
in only 5 of 609 culture-negative patients, all of whom were symptomatic with
pulmonary disease. The test detected 200 of the 205 patients with rifampicin
resistance (97.6% sensitive) and was over 98% specific in
rifampicin-susceptible patients.

"The Xpert(R) MTB/RIF test is a ground-breaking advance, which is great
to see coming from a product development partnership," said Dr Peter Small,
Senior Program Officer for TB at the Bill & Melinda Gates Foundation, whose
accompanying editorial was published today. "We also need additional support
from many partners to ensure that new technologies reach those in need, and
truly disrupt the spread of TB."

About FIND:

FIND is a non-profit Swiss organization established in 2003, with offices
in Switzerland, Uganda and India. Its mission is to develop, evaluate,
demonstrate, and accelerate the roll out of new diagnostic tests and
platforms for diseases of poverty, including TB, malaria and human African
trypanosomiasis. FIND's approach is to address diagnostic needs across
disease areas so that tests can also be implemented at levels of the health
care system closer to where patients first seek care. FIND has active
collaborations with over 100 partners, including Ministries of Health,
bilateral and multilateral organizations, such as WHO, research
institutes/academia, commercial partners and clinical trial sites.

In addition to its contribution to diagnostic advances for TB (with four
diagnostic tools endorsed by WHO into global policy since 2007), and malaria
(with the completion of the first-ever product testing program for rapid
diagnostic tests), FIND has a significant program targeted at neglected
diseases. Current donors include the Bill & Melinda Gates Foundation, the
Government of the Netherlands, the European Union, UNITAID, the UK Department
for International Development, National Institutes of Health (USA) and
others. FIND is ISO 9001:2008 and ISO 13485:2003 certified.

For more information, please visit: www.finddiagnostics.org/

(1) Boehme et al., Rapid Molecular Detection of Tuberculosis and Rifampin
Resistance.

    CONTACTS:

    For Media Inquiries:
    Lakshmi Sundaram
    Advocacy Officer
    +41-79-935-6419
    Lakshmi.sundaram@finddiagnostics.org

    In the US
    Ian Temple
    Senior Associate | Global Health Strategies
    +1-347-852-0708
    itemple@globalhealthstrategies.com

Media, Lakshmi Sundaram, Advocacy Officer of FIND (Foundation for Innovative New Diagnostics), +41-79-935-6419, Lakshmi.sundaram at finddiagnostics.org; or Ian Temple, Senior Associate | Global Health Strategies, +1-347-852-0708, itemple at globalhealthstrategies.com, for FIND (Foundation for Innovative New Diagnostics)