Unique GeneXpert(R) System Capabilities Enable Powerful New TB Diagnostic Tool
SUNNYVALE, Calif., April 27 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the release of Xpert(R) MTB/RIF as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. For the first time, European clinicians will have access to a rapid test that can simultaneously identify Mycobacterium tuberculosis (MTB) and resistance to rifampicin (RIF), a common first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant (MDR-TB).
Xpert MTB/RIF is expected to enable clinicians to dramatically improve patient outcomes -- a situation possible only through on-demand, actionable test results that can help guide therapy decisions during an initial patient visit. The new test, developed in partnership with the Foundation for Innovative New Diagnostics (FIND), the
According to the World Health Organization (WHO), approximately two billion people are currently infected with MTB. An estimated nine million people develop active TB each year, and two million people lose their lives to the illness. This equates to one life every 20 seconds.
"With the documented re-emergence of TB and the development of drug-resistant strains, the need for accurate and rapid detection of tuberculosis is becoming increasingly acute," 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 this test. Clinicians will now be able to obtain dependable test results in virtually any clinical setting not only for detection of TB, but simultaneous determination of whether or not it is a drug resistant strain. Xpert MTB/RIF should be a breakthrough technological leap forward in helping to ensure appropriate therapeutic management and in helping to halt transmission of this disease."
"I would also like to note that the Xpert MTB/RIF is Cepheid's first test released in the new Reagents on Board configuration. This new test configuration includes the packaging of liquid reagents along with the previously included dry reagents in the test cartridge. This added feature makes the test procedure even easier to perform and further reduces hands-on time to about one minute. This new test configuration is also expected to form the foundation for Cepheid's projected future line of CLIA waived products."
Appropriate therapeutic management has been a significant factor in the development of drug resistant TB strains. Optimal management of the disease requires access to rapid detection, prevention, and treatment.
"Rapid diagnosis of rifampicin-resistant TB will have will have three main benefits, including earlier proper treatment, earlier interruption of the transmission chain-of resistant strains, and promote appropriate accommodation of patients infected with a resistant strain," said Dr. Sabine Rusch-Gerdes, Head of the National Reference Center for Mycobacteria, Borstel, Germany. "This will undoubtedly save more lives by reducing the time spent on inappropriate and ineffective patient treatment which ultimately promotes the development of further drug resistance."
According to data published by WHO, only 2 percent of multidrug-resistant (MDR) TB cases worldwide are being diagnosed and treated appropriately. This may leave MDR-TB patients untreated for weeks or months, leading to an increased likelihood of community transmission and eventual death of the patient.
"Multidrug-resistant TB is becoming increasingly prevalent throughout the world, making TB harder to treat with the usual 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 anywhere testing is needed."
Currently, the most common testing method for TB is sputum microscopy, or the 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. As a result, TB is under-diagnosed today -- a major contributor to the 90,000 new TB cases and 10,000 deaths that occur annually in Europe alone. The Health Protection Agency recently announced that the number of TB cases reported in the United Kingdom is actually increasing, with a 2 percent rise in reported cases in 2008 when compared to 2007.
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.
"We designed this test so that it could be used by someone with minimal training," said UMDNJ's David Alland, M.D. 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."
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 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.
About the GeneXpert(R) System Molecular Diagnostic Platform
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests 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 http://www.cepheid.com for more information.
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; uncertainties inherent in the regulatory process; regulatory developments and changing practices regarding testing; customer and market acceptance of the product; pricing of the new product, and the fact that Cepheid expects initial sales of the product to be under a compassionate pricing model; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; and the uncertain impact of the global economic downturn. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2008, filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
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