Cepheid – Enabling Access to Molecular Diagnostic Testing Everywhere

Molecular diagnostics plays a vital role in patient care, by providing physicians with the specific information that they need to identify and treat the broad range of ailments presented across medical institutions. The diagnostic tests provided must effectively demonstrate clinical utility, adherence to quality requirements for reproducibility, and congruous specificity and sensitivity performance.

By leveraging these aspects, Cepheid set an unparalleled standard for innovation in automated molecular diagnostics, more than a decade ago. Today, Cepheid develops, manufactures, and markets, fully-integrated systems for diagnostic testing in the clinical market. Its solutions also find wide application in its legacy industrial, biothreat, and partner markets.

“Our mission is to deliver a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.”, says John Bishop, CEO, Cepheid.

The molecular diagnostics company was founded in 1996, with a vision to develop a novel system that had advanced capabilities. The system was conceptualized as a conduit to simplify the highly complex, multi-stage process that existed for the detection and analysis of nucleic acids like DNA, in samples like food, blood, urine, or industrial water.

The vision gave rise to Cepheid’s first instrumental solution in 2000. The revolutionary SmartCycler System merged the amplification and detection phases of nucleic acid testing into a single platform, therefore boosting the capability to rapidly detect harmful pathogens and diseases.

The SmartCycler system was definitely ahead of its time, and therefore enjoyed broad adoption within the medical and clinical research industry. At the same time, the company stayed true to its mission of constant innovation and evolution of its capabilities and began to develop its next platform, the GeneXpert System.

In 2001, Cepheid, in collaboration with Northrop Gruman, was at the heart of the Biohazard Detection System (BDS) for the United States Postal Service. The GeneXpert System, therefore, played an important role in Amerithrax, which was one of the worst biological attacks in US History, and which subsequently raised concerns over the use of biological agents in terrorist attacks.

After this, Cepheid continued to strive to deliver the GeneXpert System, and an associated menu of proprietary tests, to the clinical market. The fully automated, “game-changing” GeneXpert System was officially launched into the clinical market in 2005, with the release of Xpert GBS; a test for intrapartum screening that could detect Group B Streptococcus in labor and delivery.

GeneXpert has come a long way since then, with the introduction of 20-FDA-cleared tests, and 27 CE-IVD tests, that have applications in healthcare-associated infections, virology, sexual health, and women’s health. The WHO too, lauded and endorsed Cepheid’s Tuberculosis test, Xpert MTB/RIF.

The GeneXpert System’s unique modular configuration, and impeccable performance, have elevated it to a platform that can cater to the testing requirements of any medical institution. It has the robust capability to perform as little as one and as many as eight tests simultaneously.

The system has been effectively designed for a diverse range of user categories that range from reference laboratories and central hospital laboratories to satellite testing locations, including intensive care units (ICUs) and emergency departments within hospitals, and doctors’ clinics. With more than 20,000 systems spanning 180 countries, it is, therefore, no wonder that the platform is the most popular and trusted molecular diagnostics system globally.

In 2015, Cepheid announced that it was in the process of developing tests for the oncology market, and would also launch its newest system innovation called the GeneXpert Omni. The latter is a connected and portable device that would cater to the needs of physician offices and other near-patient applications, and it debuted in late 2019.

Today, Cepheid functions within the Danaher family of Operating Companies. It strives to deliver the benefits of seamless, accessible, and accurate molecular testing systems to the patient, hence bolstering an improved quality of care, cost-effectiveness, and better outcomes.

Cepheid is committed to providing high-quality products and services that consistently meet or exceed customer expectations. The focus on quality begins at the earliest stage of product design and carries through to the end-user,” says John Bishop.

With a patient-centric approach, Cepheid’s continually improving, flexible solutions have been at the forefront of digitally transforming molecular diagnostics, so that fast and accurate results are realistic possibilities.