Cepheid Announces Results Of Validation Study For Use Of Xpert HPV In Primary Cervical Cancer Screening

SUNNYVALE, Calif., July 12, 2016 /PRNewswire/ -- Cepheid CPHD today announced the publication of a validation study assessing the use of Xpert HPV (Human Papillomavirus) as a front-line cervical screening test in certain countries outside the United States.  "Performance of a cartridge based assay for the detection of clinically significant HPV infection – lessons from VALGENT (Validation of HPV Genotyping Tests)" has been published on the Journal of Clinical Microbiology website,¹ concluding that "the clinical performance and reproducibility of Xpert is comparable to well established HPV assays and fulfills the criteria for use in primary cervical cancer screening."

"In two years, we have seen at least four European countries – including England² just last week - initiate plans to move to front-line HPV testing as a screen for cervical cancer," said John Bishop, Cepheid's Chairman and Chief Executive Officer.  "As shown in large European studies, HPV as a front-line screening test is demonstrably more effective than cytology in identifying women at risk for cervical pre-cancer or cancer,³  and Cepheid is very pleased to be extending the options available to ensure that as many women as possible have access to this important screening test."

In the published paper, Cuschieri et al. reported performance of Xpert HPV compared to GP5+/6+ EIA and the Hybrid Capture 2 HPV Test in an aggregated data set with a relative sensitivity for CIN2+ of 0.984 and relative specificity for ≤CIN1 of 1.006.   Intra-lab reproducibility was reported at 96.9%, and inter-lab reproducibility was 97.8%.  Xpert HPV comfortably met the requirements established in international guidelines for primary screening tests, commonly referred to as the Meijer protocol. 

"Xpert HPV has performance highly comparable to established and validated assays, and can now be added to the list of tests validated for primary cervical cancer screening," said Jack Cuzick, Ph.D., FRS, Head of the Centre for Cancer Prevention.  "It is an easy to use test that reports individual high risk HPV results in less than one hour."

HPV infection is the most common sexually transmitted infection in the world.  A handful of HPV genotypes, known as high-risk HPV (hrHPV), can present severe health risks.  hrHPV has been linked to more than 99% of cervical cancers worldwide.⁴  Xpert HPV detects 14 types of hrHPV DNA, with specific call-outs for HPV 16 and HPV 18/45.  The test can be done completely on site and provides results in less than an hour.

About Cepheid

Based in Sunnyvale, Calif., Cepheid 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 GeneXpert Systems and Xpert Tests

With more than 10,000 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' system.  The GeneXpert System's modular configuration means that the system is the most scalable available, offering the ability to perform from one to eighty Xpert tests at the same time.  As a result, the GeneXpert System meets the throughput requirements of customers of all sizes - from lower volume point-of-care settings to higher volume reference laboratories – enabling accurate, fast and cost effective test results.

GeneXpert Systems run proprietary Xpert test cartridges.  The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 23 tests outside the US, and 20 tests in the US.  More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com. 

Forward Looking Statements

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 performance, reproducibility, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the Xpert HPV test and the test's impact on identifying women at risk for cervical pre-cancer or cancer.  Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from Cepheid'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 the Company's tests by clinicians and future changes in medical practice and protocols; the Company's 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 global markets; the Company's research and development budget; 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.

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.

For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
corporate.communications@cepheid.com

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SOURCE Cepheid