Cepheid announced the issuance of U.S. Patent No. 6,431,476 covering apparatus and methods for lysing cells and micro-organisms in cartridges using ultrasonic energy. This technology is a key aspect of Cepheid's rapid, automated genetic testing platform, the GeneXpert system.

In order to gain access to nucleic acids and other molecules inside a cell or virus for testing, the cell or virus must be lysed, or broken open. Traditional methods for lysing can involve harsh chemicals, high temperatures and long reaction times. In addition, these lysing chemicals are usually inhibitory to genetic amplification and detection methods such as the polymerase chain reaction (PCR). At the current time, complex and expensive nucleic acid purification and concentration steps are routinely required to remove these lysing chemicals prior to amplification and detection.

The technology covered by Cepheid's new patent can eliminate such purification and concentration steps, vastly simplifying genetic testing procedures. Using ultrasonic lysing in the disposable GeneXpert cartridge, sample preparation can be reduced from several hours, in the case of hardy organisms such as tuberculosis and anthracis, to only several minutes. This technology is broadly applicable to other cells, bacteria and viruses.

GeneXpert is expected to be the first system to allow raw biological samples, such as urine, blood and swabs, to be processed automatically in a disposable cartridge, yielding a genetic result in approximately 30 minutes. Benefits of the system are currently being demonstrated in a pilot program with the US Postal Service to evaluate the potential detection of biothreat organisms in the mail.