Healthcare Industry News: U.S. Food and Drug Administration
News Release - October 5, 2017
Cepheid Expands Respiratory Disease Portfolio with Xpert Xpress Strep AAccurate and Reliable Group A Strep Detection in as soon as 18 minutes(1)
SUNNYVALE, Calif., Oct. 5, 2017 -- (Healthcare Sales & Marketing Network) -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert« Xpress Strep A. The test provides rapid, accurate, and reliable molecular detection of Streptococcus pyogenes (Group A ▀-hemolytic Streptococcus or Strep A) DNA from patient throat specimens in as little as 18 minutes for a positive result.
A recent report by the World Health Organization notes that the burden of Group A streptococcal infections globally continues unabated, even though the organisms remain susceptible to penicillin2. Antibiotic treatment of acute pharyngitis, often caused by viruses and not bacteria, is often initiated inappropriately, in an effort to shorten the course of illness and prevent acute rheumatic fever, a complication of severe Group A Strep infection. However, treatment of infections not informed by laboratory testing as to the causative pathogen can lead to organisms developing increased drug resistance3. Delivering accurate on-demand test results helps healthcare providers improve antibiotic treatment strategies to limit antibiotic use to those patients who are likely to benefit from it.
"Untreated infections of the upper respiratory tract caused by Group A Streptococci can lead to serious health consequences," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "The speed and accuracy of the Xpert« Xpress Strep A test allows patients and their healthcare providers to expect a definitive diagnosis at the point-of-care, and to avoid the need for lengthy and cumbersome confirmatory bacterial cultures."
Xpert Xpress Strep A is the third test to join Cepheid's new Xpert Xpress family for no-compromise speed, accuracy, and quality. Xpert Xpress Strep A utilizes automated real-time polymerase chain reaction (PCR) to detect Streptococcus pyogenes DNA. The built-in reagents deliver high performance specifications with no requirements for culture confirmation of negative results unless clinical symptoms persist or there is an outbreak of acute rheumatic fever (ARF).
For more information on Cepheid's GeneXpert Systems or the complete menu of Xpert and Xpert Xpress tests, visit www.cepheid.com.
Based in Sunnyvale, Calif., Cepheid 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.
- For a positive result only
- Steer AC. et al. Status of research and development of vaccines for Streptococcus pyogenes. Vaccine. 2016 Jun 3;34(26):2953-8. doi: 10.1016/j.vaccine.2016.03.073. Epub 2016 Mar 29
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