Cepheid announces new diagnostic technology in ongoing efforts to halt the spread of TB
Cepheid’s GeneXpert® System
Cepheid (Nasdaq: CPHD) today announced details of technology expected to revolutionize the speed at which both Mycobacterium tuberculosis (TB) and the resistance to common drug treatment for the disease can be diagnosed.
The new test technology, developed in partnership with Foundation for Innovative New Diagnostics (FIND), the University of Medicine and Dentistry of New Jersey (UMDNJ), and the National Institute of Allergy & Infectious Diseases (NIAID), will leverage the power of Cepheid’s GeneXpert® System to deliver a highly accurate diagnosis of the disease in less than two hours.
According to the World Health Organization (WHO), approximately two billion people are infected with Mycobacterium tuberculosis. Each year approximately nine million people develop active TB and two million people lose their lives to the illness. This equates to one life every 20 seconds.
“One of FIND’s main goals is to help to save the millions of lives that are needlessly lost to TB every year,” says Giorgio Roscigno, Chief Executive Officer of FIND. “Cepheid’s commitment to researching and bringing this test to market has been outstanding, as is their intention to sell Xpert® MTB/RIF on a cost for product basis in the developing world, where it is most needed. We are proud to be working with them on this project.”
Rapid diagnosis of TB is vital in areas such as sub-Saharan Africa and Southeast Asia due to the close connection between HIV and TB. Sputum microscopy, which often delivers poor sensitivity in patients suffering from tuberculosis, is almost completely ineffective in those who also have HIV co-infection. The weakened immune system of an HIV-positive person is particularly susceptible to infection, resulting in one third of the 33 million HIV sufferers worldwide also infected with TB. Left untreated, 90 percent of these people will die within months of first contracting the disease, reinforcing the urgent need for an accurate and rapid test.
“The need for accurate and rapid detection of tuberculosis is becoming increasingly acute with the development of drug resistant strains and the growing at-risk populations in the developing world,” said John Bishop, Cepheid’s Chief Executive Officer. “The GeneXpert System has a unique level of technical capability never before seen in molecular diagnostics and this capability is on full display with the Xpert MTB/RIF test. Clinicians will now be able to obtain dependable test results for not only detection of TB but simultaneous determination of whether or not it is a drug resistant strain in virtually any clinical setting. Appropriate therapeutic management has been a significant factor in the development of drug resistant strains of tuberculosis and the availability of the Xpert MTB/RIF test should be a significant technological leap forward in helping to ensure proper therapeutic management and in helping to halt transmission. We are looking forward to making this test available as a CE IVD Mark product next month.”
Xpert MTB/RIF not only detects the presence of TB, but also identifies whether it is resistant to Rifampicin, a common first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant (MDR-TB). The test is expected to enable physicians to dramatically improve patient outcomes — possible only with on-demand, actionable results to guide therapy decisions within the timeframe of an initial patient visit.
“Multidrug-resistant TB is becoming increasingly prevalent throughout the world, making TB harder to treat with the usual treatment regimen that includes Rifampicin,” said David H. Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “In my opinion, this new test is one of the most important diagnostic developments to have occurred in many years. It is the most technologically advanced test for TB ever developed, yet it is simple enough to perform in all corners of the world, including resource-limited settings in which it is most needed.”
Currently, the most common testing method for TB is the sputum microscopy, or smear test, that has remained largely unchanged in its sophistication and sensitivity for over 100 years. The smear test has been proven to only detect around half of all active TB cases and is not capable of identifying drug resistance. Patients who remain undetected are often co-mingled within general hospital populations, placing others at risk of infection. Due to their low accuracy, smear tests are followed up with culture tests, which offer more accurate results but take several weeks. To determine drug resistance, culture testing can take months to return a result. For patients in the developing world, lengthy turnaround times of current test methods can lead to catastrophic consequences as the chain of transmission grows.
“We designed this test so that it could be used by someone with minimal training,” said UMDNJ’s David Alland, MD, who collaborated closely with Cepheid and FIND with support from the NIAID. “We're gratified to find that it requires less hands-on work than the acid fast smear, long a standard method to identify tuberculosis, but it is much more sensitive.”
Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif., is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The company’s systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company’s easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See www.cepheid.com for more information.
S.F. Chronicle article on Cepheid's low cost TB test.
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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 product performance and future market opportunities. 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: unforeseen manufacturing problems; inherent uncertainties related to the regulatory process; regulatory developments and practices regarding testing; market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; the ability of Cepheid to market the product in other markets outside of developing countries and the pricing and margins it receives in those markets; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2008 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
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FIND, based in Geneva, Switzerland, is a not-for-profit Swiss foundation dedicated to the development of improved diagnostic tests that will have a measurable impact on TB morbidity and mortality, particularly in high-endemic countries. Since its establishment in 2003, FIND has received endorsement from WHO for three new TB technologies that are currently being rolled out with partners in 16 countries that carry a high burden of MDR TB cases. FIND’s mission is to drive the development and implementation of accurate and affordable diagnostic tests that can be used as near as possible to where patients first seek care. At this time, the FIND’s disease portfolio includes TB, malaria and human African trypanosomiasis and current donors are the Bill & Melinda Gates Foundation, the European Union, the Government of the Netherlands, UNITAID, Irish Aid and other institutions and private donors. FIND is ISO 9001:2000 and ISO 13485:2003 certified.