SUNNYVALE, Calif., July 25, 2013 /PRNewswire/ --Cepheid (Nasdaq: CPHD) today announced it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert® MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market. Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects rifampin-resistance associated mutations of the rpoB gene.
"With results available to clinicians in approximately 2 hours instead of weeks, the dramatic impact of Xpert MTB/RIF on identifying TB positive patients and optimizing their drug therapy has been well documented outside of the U.S.1," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Now, U.S. clinicians can leverage those same transformative results not only for the detection of TB (tuberculosis), but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy."
Designed for use on Cepheid's GeneXpert® Systems, Xpert MTB/RIF not only detects the presence of MTB-complex DNA, but also mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant (MDR-TB). Patients with multidrug-resistant TB need more intensive and prolonged therapy. Xpert MTB/RIF will enable U.S. clinicians to significantly improve patient outcomes by providing rapid results that guide therapy decisions early in the course of disease, not 6 weeks later as is the case with standard laboratory methods.
"Xpert MTB/RIF is the most technologically advanced test for TB ever developed, yet it is simple enough to be performed across multiple shifts in laboratories across the country," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "About one-third of the human population is infected with TB, but most do not have active disease that requires treatment. Ruling out active disease in TB suspects is a relatively common task of domestic clinical laboratories. We think that the Xpert MTB/RIF test will help to eliminate guesswork and deliver maximum medical value in the management of TB here in the U.S., as already demonstrated abroad."
In the early 1900s TB was the leading cause of death in the United States. Tuberculosis disease and deaths have declined steadily from the early 1900s due largely to the introduction of effective antibiotics and improvements in living conditions. While some improvements in global control of TB have been achieved over the last decade, TB continues to be a leading cause of death from an infectious disease in many countries. In 1993, the World Health Organization (WHO) declared TB a "global health emergency." 2
While TB in the U.S. is at its lowest level since 1953, rapid and accurate diagnosis of TB continues to be a challenge, especially among immunocompromised patients and the elderly. The symptoms of TB in its early stages are similar to many different types of infections, thus having an accurate test to rule out the disease is critical for managing patients in the U.S. According to the CDC, in 2012 63% of reported TB cases in the U.S. occurred in foreign-born persons, with case rates that were 11.5 times higher than among U.S. born persons.3 Yet, any nationality can fall victim to this disease. Returning U.S. travelers may also carry the disease and it can be just as deadly, especially if it is drug resistant. The ability of Xpert MTB/RIF to provide rapid information on the presence of TB and potential drug resistance within two hours distinguishes it from other available TB tests.
Tuberculosis remains a major global health concern, with an estimated 8.7 million new cases reported worldwide in 2011 according to the WHO. Continuing the decline in TB cases in the United States will require sustained focus on domestic TB control activities and further support of global TB control initiatives. 4
Xpert MTB/RIF is now available for immediate shipment in the U.S. For more information on Xpert MTB/RIF and Cepheid's entire portfolio of molecular diagnostic tests, please visit www.cepheid.com.
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 http://www.cepheid.com.
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 efficacy, the availability and timing of product shipments, and 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: the performance, clinical efficacy and impact on patient outcomes of any new product; uncertainties related to the regulatory processes for new products; supply, development and manufacturing problems, or other unforeseen difficulties in order fulfillment; unknown levels of market acceptance for new products; the level of testing at customer sites; 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 2012 and in its most recent quarterly report on Form 10-Q, each 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.
- Boehme, C. C., et al. (2011). "Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study." Lancet 377(9776): 1495-1505