Cepheid and the University of Medicine and Dentistry of New Jersey (UMDNJ) have received $1.3 million from the NIH to develop sample processing and amplification methods for detection of bloodstream bacteria using nested PCR on the GeneXpert® System. The grant could span five years and total $5.5 million.
The overarching goal of the project, scheduled to run through February 2017, is to develop tests to detect a variety of bacterial bioterrorism agents in the case of a terrorist attack. “This is very similar to a previous NIAID-funded program conducted on tuberculosis, which supported development of six-color fluorescent detection and reagents-on-board,” said David Persing, M.D., Ph.D., Cepheid's chief medical and technology officer.
“We considered that program to be a win-win because some of our tests, in addition to the MTB/RIF test, now employ six-color detection technology. We expect to see similar benefits—both direct and indirect—as a function of this new program, and expect to be able to fully leverage our capabilities in the areas of nested amplification and multiplex PCR pursuant to the next generation of GeneXpert products.” The company expects to be able to employ the technology in future clinical products including planned Xpert® tests for sepsis, ventilator pneumonia, and other critical infectious diseases.
“Cepheid's scientists will focus primarily on sample preparation methods for infectious agents from a wide variety of difficult sample types, especially whole blood—one of the most difficult specimens for sepsis detection,” says John Bishop, Cepheid's CEO. “Clinicians want accurate, rapid results directly from a patient specimen without waiting for culture results. This program is expected to contribute to the advancement of products where difficult sample types are present.”
The GeneXpert System is a closed, self-contained, fully integrated, and automated platform. It combines on-board sample preparation with real-time PCR amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.