John Bishop, CEO
Since the initial phase of the pandemic, the lack of test equipment and reagent capacity as well as insufficient protective gears like PPE have already slowed down the deployment of COVID-19 molecular diagnostics. Adding to this, the sudden uptick in the testing processes has increased the stress and exhaustion of laboratory professionals. Following sample collection, they have to conduct tests in the central laboratory, before procuring the results. And the manual nature of these steps invariably keeps clinicians too preoccupied with the existing test volume to focus on increasing the number of diagnostic tests. In face of these challenges, the need for automated molecular diagnostics is becoming even more pronounced as healthcare professionals realise that the only way to curb a fast transmitting virus similar to COVID-19 requires vigorous and fast diagnostic capabilities.
Stepping up to meet this timely demand is Cepheid—one of the early proponents of automated molecular diagnostics. Cepheid, with its proprietary and fully-automated GeneXpert family of diagnostic systems, is currently helping clinicians and diagnosticians incorporate cutting-edge and efficient molecular diagnostic capabilities in their arsenal. “The dramatic impact of SARS-CoV-2 has been felt by us all, and we understand that a reliable supply of SARS-CoV-2 tests is critical to the communities our healthcare institutions serve—for the coming Flu season and beyond,” says Warren Kocmond, president and COO of Cepheid. The company’s GeneXpert family of systems combines workflow flexibility, 24/7 testing accuracy, and user-friendly design in an astonishingly beautiful and compact package. It provides a test menu spanning multiple clinical applications including healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology. And whether it is a small medical clinic or high-volume reference laboratory or a hospital, the clients can leverage GeneXpert diagnostic systems to enhance the speed and accuracy of their molecular diagnostics capabilities.
How It All Began…
Cepheid was founded in 1996 with a vision to develop an innovative system that simplified a highly complex, multi-stage process for the detection and analysis of nucleic acids, such as DNA, in samples such as blood, urine, food, and industrial water. The company officially launched its fully-automated GeneXpert system into the clinical market with the release of Xpert GBS—a test for intrapartum screening of Group B Streptococcus in labor and delivery—in 2005. Since then, 20 FDA-cleared tests and 27 CE-IVD tests have been introduced on the GeneXpert system— from healthcare-associated infections to women’s health, sexual health, and virology.
At present, the GeneXpert family of diagnostic systems comes in three different variations: GeneXpert Infinity, GeneXpert Xpress, and the original GeneXpert System. Notably, both Infinity and Xpress are built on top of the proven GeneXpert platform with Cepheid’s proven GeneXpert module at their analytic heart, and these systems use the same patented cartridge technology for every Xpert test. Laboratories equipped with GeneXpert System thus no longer need rows of equipment and extensively trained staff to deliver molecular results. They can make on-demand molecular testing available to everyone with unprecedented speed and ease of use. With its compact design, GeneXpert allows for portability in the field and can run tests just about anywhere. For example, GeneXpert Xpress is a standardised clinical laboratory improvement amendment (CLIA) waived molecular testing platform, which can be leveraged in any healthcare setting, from community hospitals to physician offices and specialty clinics. It helps in reducing the time needed for multiple testing. Similarly, GeneXpert Infinity is an automated cartridge-based test platform that enables a comprehensive menu of tests to be run at a single time with exclusive “load and go” capability. It provides maximum flexibility in system placement, staffing, and menu availability.
Owing to such innovative molecular testing systems, Cepheid is experiencing a high demand for its robust automated software for enhancing testing capabilities amid the COVID-19 outbreak. To meet this demand, and do more, the company is constantly innovating and evolving its capabilities to bring greater flexibility, speed, and accuracy in molecular diagnostics. “Another goal of the capacity expansion program is to ensure supply continuity of not only our 4-Plex combination test for SARS-CoV-2, Flu A&B and RSV, but the entire portfolio of critical tests Cepheid supplies—including tests for tuberculosis, MRSA, C. difficile, CT/NG, Strep A, and many more,” concludes Kocmond.