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

SUNNYVALE, Calif. and GENEVA, Switzerland, Oct. 28, 2014 /PRNewswire/ -- 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.

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

Founded in 2003, FIND is an international non-profit organization that enables the development and delivery of much-needed diagnostic tests for diseases of poverty, including tuberculosis, malaria, sleeping sickness, hepatitis C, leishmaniasis and Chagas disease.  FIND acts as a bridge between diverse expert groups to address barriers to innovation and implementation of comprehensive and tailor-made diagnostic solutions in low-resource settings. FIND maximizes the impact of diagnostics: access to accurate treatment, disease control and eradication, efficient health care spending and empowered individuals, communities and countries. Over the last 11 years, FIND led the delivery of 11 new diagnostic tools and created an enabling environment for countless more through specimen banks, reagent development and better market visibility. FIND has also supported the scale-up of diagnostics through implementation, quality assurance and lab strengthening work. FIND has active collaborations with over 100 partners, including research institutes/academia, ministries of health, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites. Learn more about FIND at www.finddx.org.

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.

This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to the availability, performance, sensitivity, speed, pricing, accuracy and clinical efficacy of our products, including relative to competing products and technologies, the breadth and speed of test menu expansion, the results of clinical trials, future medical practice dynamics, including the utilization of our tests in a clinical environment, and the ability of our products to cut future medical treatment costs.  Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: test performance in the field; utilization of our tests by clinicians; our ability to successfully and timely develop new products; the completion of clinical trials for new products successfully and in a timely manner; uncertainties related to the United States FDA, European and other regulatory processes; the Company's ability to successfully introduce and sell products in clinical markets; the Company's research and development budget; the availability of foundation and governmental funding; unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the impact of competitive products and pricing; the costs of product components and other factors affecting product pricing; the Company's ability to manage geographically-dispersed operations; and underlying regulatory, political and market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.

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Source: Cepheid