Cepheid Receives FDA Clearance for Xpert Flu/RSV XC

Redundant targets extend coverage for detection of seasonal and emerging novel viruses

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Nov 24, 2014, 04:05 ET

SUNNYVALE, Calif., Nov. 24, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert^®Flu/RSV XC, an on-demand molecular test for accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection. Xpert Flu/RSV XC runs on Cepheid's GeneXpert^® System, the world's leading molecular diagnostic platform with more than 7,500 systems installed worldwide.

Upper respiratory infections are one of the most common reasons for doctor and hospital visits and, in the United States, are the most common illness leading to school or work absences. Early symptoms for a wide variety of viral and bacterial respiratory infections are similar, yet treatment is different depending on the cause of infection. With Xpert Flu/RSV XC, hospitals and clinicians can be prepared to reliably diagnose and differentiate influenza strains and RSV in real-time.

"Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Recent media coverage of serious viruses such as Enterovirus D68 and Ebola have raised public awareness, and created a greater need for healthcare workers to deliver timely and accurate test results for flu or RSV infection."

The flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. It can cause mild to severe illness, and at times can lead to death. Patients infected with the flu may be able to infect others beginning one day before symptoms develop and up to five to seven days after becoming sick. Some people, especially young children and people with weakened immune systems, might be able to infect others for a longer time.¹

Respiratory syncytial virus (RSV) is a very common virus that leads to a wide range of respiratory symptoms in children and older adults. It can be more serious in young children, especially those in certain high-risk groups. Most infants have had an RSV infection by age two.² RSV is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age.³

Doctors Donna M. Wolk and Raquel M. Martinez, investigators at Geisinger Health System, were involved in investigational testing of Xpert Flu/RSV XC during Cepheid's product development phase. Their Microbiology Research team is planning a pilot testing program they call FluWorks^©. This program aims to allow test results to be immediately delivered to physicians and patients or designated family members via electronic health records, web portal, or text messaging.

"We are anxious to understand the role that the Xpert Flu/RSV XC test can play in Geisinger's FluWorks program, designed to improve patient care, clinical operations, and laboratory stewardship. Rigorous investigational testing documented the assay's high accuracy and speed," said Dr. Wolk. "This winter, we plan to leverage the test's unique design to quickly test patients presenting with influenza-like illness at Emergency Departments, out-patient clinics, and in selected Urgent Care Clinics."

The severity of a flu outbreak can vary greatly from one season to the next depending on which flu viruses are spreading, how many people get vaccinated, and how well the flu vaccine is matched to the flu viruses that are currently causing illness.

"We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains. Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for fast and accurate detection and differentiation of Flu A, Flu B, and RSV infection," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "This test may also become a valuable asset in efforts toward pandemic preparedness, because it was designed from its inception to provide unprecedented coverage of both human and avian influenza strains."

Xpert Flu/RSV XC begins shipping in early December. For more information on Cepheid's GeneXpert Systems or a complete menu of tests, 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.

References

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 performance, speed, accuracy and clinical efficacy of our products, including relative to competing products, the breadth and speed of test menu expansion, the results of clinical trials, and future medical practice dynamics, including the utilization of our tests in a clinical environment. 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 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; 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 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 Inquiries:

Jared Tipton

Cepheid Corporate Communications

408-400-8377

[email protected]

For Cepheid Investor Inquiries:

Jacquie Ross, CFA

Cepheid Investor Relations

408-400-8329

[email protected]

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SOURCE Cepheid