Recently, Cepheid (CPHD) recalled its blood culture (“BC”) testing product, Xpert MRSA/SA, as it was generating false MRSA negative results, implying that wrong treatment was being delivered for Methicillin-resistant Staphylococcus aureus (“MRSA”) infection. MRSA is a multi-drug resistant bacteria that can cause several infections, which are very difficult to treat.
Xpert MRSA/SA BC continued to meet all performance claims as delineated in the current product labeling, conversely, further investigations has led to the conclusion that one of the grounds of false MRSA negative results is the emergence of some new MRSA strain types.
Cepheid notes that Xpert MRSA/SA is not required to be returned to the manufacturer as this action has been taken as a corrective measure. Moreover, the company has also imparted the details of the action to the US Food and Drug Administration (“FDA”).
Cepheid stated that the customers, except in a case when an MRSA negative/SA positive result is obtained, could continue to use the product. In case of false MRSA negative results, the result should be stated as “MRSA indeterminate/SA positive, antimicrobial susceptibility testing pending.” Moreover, further testing is to be done based on the instructions in the Corrective Action Notice dated July 1, 2010.
Xpert tests used on the Cepheid’s GeneXpert system are unique, as they typically require less than two minutes of hands-on time with unprecedented ease of use and give results instantly, in most cases within an hour.
The success of Cepheid’s business depends to a large extent on its ability to continue increasing sales of the Xpert tests and introduction of further tests for the Clinical market. Thus, the successful expansion of business in the Clinical market is critical for the company’s revenue generation as well as meeting the long-term goals.
Cepheid is a molecular diagnostics company that develops, manufactures, and markets fully integrated systems for conducting various tests in the Clinical market, as well as for applications in the legacy Biothreat, Industrial and Partner markets. The company faces competition from larger, more diversified diagnostic firms such as Gen-Probe (GPRO), Abbott Laboratories (ABT) and Becton Dickinson (BEC).
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