Cepheid, FIND & Rutgers announce collaboration for next-generation innovations to game-changing Xpert MTB/RIF test

Sunnyvale, California & Geneva, Switzerland – 28 October 2014 – Cepheid (Nasdaq: CPHD), FIND, and Rutgers New Jersey Medical School, today announced details of a collaboration to develop Xpert® MTB/RIF Ultra, a next-generation test for Mycobacterium tuberculosis (TB) with increased sensitivity to aid in detection of patients with smear-negative TB, which is often associated with HIV co-infection. The collaboration is also receiving additional support from the National Institute of Allergy and Infectious Diseases at the NIH¹.

Technological innovations will leverage the power of Cepheid’s GeneXpert® System, currently the only platform for near-patient molecular TB testing². There are over 7,500 GeneXpert Systems deployed globally, including over 3,500 installed in 110 High Burden Developing Countries (HBDC), making it the most widely distributed molecular platform in the world. Xpert MTB/RIF Ultra will run on existing 6 color GeneXpert Systems and is expected to be provided to HBDC markets at the same price as Xpert MTB/RIF.

“There is a pressing need for continued innovation in the field of TB diagnostics. The low sensitivity of smear microscopy limits its impact on TB control,” said Dr. Catharina Boehme, Chief Executive Officer of FIND. “Xpert MTB/RIF Ultra has great potential to transform the way we diagnose the three million people who every year fail to receive TB testing or treatment. We are proud to partner with Cepheid in launching this highly sensitive and rapid test that will identify even more patients than its predecessor and make quality diagnostics a reality for people in the developing world.”

“One reason that Xpert MTB/RIF has been heralded as a game-changer is its capability to detect individuals with infection. However, low levels of organisms are especially prominent in patients coinfected with HIV. These patients are commonly referred to as smear-negative because traditional microscopy does not detect their TB infection,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “An ability to identify these patients with an extremely high level of sensitivity with a single test represents a significant step forward in what has already been hailed worldwide as a revolutionary advance in the diagnosis of TB. ”

A primary reason that current tests have difficulty identifying early-stage TB is because the target DNA in patient samples is below the levels of test detection. The Xpert MTB/RIF Ultra collaborative team plans to capitalize on Cepheid’s unique, cartridge-based nested PCR amplification capability to amplify patient DNA samples to a level that can be more accurately detected. The current Xpert MTB/RIF test has a limit of detection (LOD) of 130 cfu/ml. New innovations, including a larger DNA reaction chamber in the cartridge, will enable Xpert MTB/RIF Ultra to bring the LOD down ten-fold, to approximately10 cfu/ml (across all strains) — a level similar to or potentially better than liquid culture.

“The data clearly show that TB is still treated empirically in primary care settings because clinicians fear that a negative test result only means that the disease is not advanced enough to be detected. In addition, some serious cases of TB can be smear-negative because a patient has a poor cough or is HIV positive,” said David Alland, M.D., Professor and Chief, Division of Infectious Diseases, Center for Emerging Pathogens at Rutgers New Jersey Medical School. “There is a huge need for an on-demand test that can accurately identify individuals with early-stage TB who currently test negative with other tests. Our preliminary results strongly suggest that Xpert MTB/RIF Ultra will not only eliminate the need for empiric therapy, it will cut TB treatment costs in half.”

Cepheid is also developing an additional test to specifically call out extensively drug-resistant (XDR) tuberculosis. XDR TB is a form of multidrug-resistant tuberculosis (MDR TB) that is resistant to the most potent TB drugs — isoniazid, rifampin, aminoglycosides, and any fluoroquinolone.

“When it comes to detecting TB, poor sensitivity for poor countries is not a winning combination,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “Our collaboration with Dr. Alland and FIND to create Xpert MTB/RIF has truly helped revolutionize TB care around the world. Millions of people currently receive effective TB care each year — but missed cases are stalling gains. This new product will help to eliminate guesswork and deliver maximum medical impact in the management of TB cases worldwide.”

Xpert MTB/RIF Ultra is expected to be available to the HBDC market in the first half of 2016.

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References:

(1) Grant number AI111397-01

(2) In the U.S. market, near-patient testing is conducted in clinical sites certified by the Centers for Medicare and Medicaid Services (CMS) to perform moderate complexity (non-waived) tests.

About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.

About FIND
The Foundation for Innovative New Diagnostics is dedicated to developing affordable, easy-to-use, cutting edge diagnostic tests that save lives in the poorest areas of the world. From proof of principle to putting new tests into practice, the organization works with diverse groups, including academia, industry, donors, partners in the field, Ministries of Health and the World Health Organization. With new diagnostics for malaria, tuberculosis and sleeping sickness already in the field, FIND is also working on other neglected diseases such as leishmaniasis, Chagas disease, and Buruli ulcer. Created in 2003, the not-for-profit Foundation is ISO certified and financed by both the private and public sectors, including the Bill & Melinda Gates Foundation, the governments of the United Kingdom (DFID), Switzerland (SDC), the Netherlands, Germany (BMBF/KfW), the United States (CDC, NIH and USAID) and Australia (AusAID), the European Union, UNITAID, The Global Fund to Fight AIDS, Tuberculosis and Malaria, UBS Optimus Foundation and others.

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For Cepheid media enquiries:
Jared Tipton
Cepheid Corporate Communications
+1 408 400-8377
communications@cepheid.com

For FIND media enquiries:
media@finddx.org

For Rutgers NJMS media enquiries:
Iveth Mosquera
+1 973 972-1216
mosqueip@njms.rutgers.edu