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. In its first phase, Cepheid was focused on its SmartCycler® System which integrated the amplification and detection phases of nucleic acid testing in a single instrument. The system was launched in 2000, the same year the Company went public.

The company’s focus temporarily shifted following the terrorist attacks in 2001. In collaboration with Northrop Grumman, the GeneXpert System was at the heart of the biohazard detection system (BDS) for the United States Postal Service. Launched in 2003, the program has delivered over 15 million test results with no false positives. While the biothreat aspect of Cepheid’s business ultimately grew to $58 million at its peak, Cepheid quickly returned to its vision of delivering the GeneXpert System, and associated menu of proprietary tests, to the clinical market.

Cepheid officially launched the 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 — from Healthcare Associated Infections to women’s health, sexual health, and virology. In 2010, the World Health Organization endorsed our newly introduced Tuberculosis test, Xpert MTB/RIF as a “game-changer for TB and MDR-TB care delivery.”

In 2015, the Company announced its intention to develop tests for the Oncology market as well as plans for its newest system innovation: the GeneXpert Omni. Targeted for physician office and other near-patient applications, the connected and portable GeneXpert Omni debuted in late 2019, in ex-U.S. territories.

Today, Cepheid operates within the Danaher family of Operating Companies. With a patient-centric approach, the Company is striving to deliver the benefits of seamlessly accessible molecular testing closer to the patient, enabling a higher quality of care, lower costs, and improved outcomes.

Xpert C. difficile/Epi Datasheet

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