Cepheid Brand Guidelines: GeneXpert, a Single-Use Cartridge & a 1996 California Start

A laboratory process put into a box.

Cepheid was founded in March 1996 in California. English Wikipedia names six founders: Thomas Gutshall, who served as the first chief executive until 2002, Bill McMillan, Kurt Petersen, Greg Kovacs, Steven Young and Allen Northrup. The company says its aim from the start was a system that simplified the multi-stage work of finding and analysing nucleic acids, including DNA, in samples such as blood, urine, food and industrial water. Its headquarters are in Sunnyvale, in Silicon Valley.

The engineering behind its later instruments did not begin in a company lab. English Wikipedia says the key engineering work on the technology that became GeneXpert, along with early versions and field testing, was done at Lawrence Livermore National Laboratory, funded through a micro-electromechanical systems programme of DARPA, by the US Army and from the laboratory’s own budget.

The first product was the SmartCycler, which the company says combined the amplification and detection stages of nucleic acid testing in a single instrument. It was launched in 2000, the year Cepheid went public on the Nasdaq. After the anthrax letters of 2001, federal agencies contracted Cepheid to help track anthrax, English Wikipedia says, and in 2003 it worked with the defence contractor Northrop Grumman on a federal contract to install anthrax detection systems at US Postal Service sites; the company says its GeneXpert system sat at the heart of that programme. John L. Bishop became chief executive in April 2002 and led the company until its sale in 2016.

GeneXpert and the cartridge.

The product that defines Cepheid is the GeneXpert system. English Wikipedia describes it as an automated form of real-time polymerase chain reaction (PCR): a sample goes into a single-use cartridge, a moulded set of plastic chambers holding the reagents, and the cartridge is loaded into a reusable desktop instrument that moves the liquid between chambers through a central rotary valve, runs the temperature cycles and reads the result optically. The cartridges are bought from Cepheid. The same instrument runs different tests when the cartridge is changed, and the range runs from small desktop units to the large GeneXpert Infinity.

Clinical use began in 2006, when the US Food and Drug Administration cleared Xpert GBS, a test for Group B Streptococcus used around childbirth. English Wikipedia says that in August 2006 the FDA placed it in the “moderate complexity” category under US laboratory rules, the first amplified real-time PCR test to receive that rating, which widened the number of laboratories allowed to run it. The company says it has since introduced more than twenty US in-vitro diagnostic tests and thirty CE-marked ones, covering hospital infections, sexual health, blood virology and respiratory disease, and that in 2015 it announced plans to develop tests for oncology.

The test that carried the name furthest was Xpert MTB/RIF, a cartridge test for tuberculosis and for resistance to the antibiotic rifampicin. English Wikipedia says it was co-developed by David Alland’s laboratory at the University of Medicine and Dentistry of New Jersey, Cepheid and the Foundation for Innovative New Diagnostics (FIND), with support from the US National Institutes of Health. On 8 December 2010 the World Health Organization endorsed the test after 18 months of assessment, its news release said, describing a fully automated test with results in about 100 minutes that could be used outside conventional laboratories. FIND announced the same day that it had negotiated preferential pricing with Cepheid, the manufacturer, for the countries most affected by tuberculosis.

How a diagnostics brand presents itself.

In vitro diagnostics is a business most people meet only at second hand, through a blood sample sent away or a result read back by a doctor. The companies behind those results make analysers, the reagents that run on them and the software that ties them together, and they sell mainly to hospital laboratories, independent labs and clinics rather than to the public.

That shapes how they look. The typical product photograph shows a white or pale grey bench analyser in a clean laboratory, sometimes linked to others in a line of automation, with sample tubes standing in racks and a touchscreen at the front. Smaller formats appear too: single-use cartridges for point-of-care machines, test strips and cassettes for rapid tests, pipettes and reagent packs. Blue and white palettes are common across the sector, along with plain sans serif type and diagrams of the laboratory workflow, and some makers have had their instruments judged on design: Sysmex’s clinical laboratory system was among the Good Design Gold Award winners in Japan in 2011.

The trade meets at a few large events. MEDICA in Düsseldorf gathers medical technology makers, and the annual meeting of ADLM, the Association for Diagnostics & Laboratory Medicine, formerly the American Association for Clinical Chemistry, brings laboratory companies together in the United States. Some of these groups grew by acquisition, so a single corporate name often sits above product names that began with other companies.

This guide sets out what can be checked about each brand: who founded it, who owns it, where its products are made and what it says about its own identity, and it marks clearly what rests only on the company’s own word. No diagnostic or clinical claims are made for any product.

A Danaher company since 2016.

Cepheid stayed independent for twenty years. On 4 November 2016 Danaher Corporation announced that it had completed its acquisition of the company: Cepheid became an indirect wholly owned subsidiary of Danaher, and its shares stopped trading on the Nasdaq, the Danaher release said. It kept its name and its Sunnyvale base, and the company says it now operates in 17 countries, with production sites in the United States, Sweden and India. Before the sale it had bought Sangtec Molecular, in February 2007, English Wikipedia says.

The installed base of instruments became the brand’s main asset in 2020. In March that year the FDA granted an emergency use authorization to Cepheid’s rapid SARS-CoV-2 test, designed to run on the GeneXpert machines already installed in hospitals; English Wikipedia puts that base at more than 23,000 systems worldwide. In October 2024 the World Health Organization approved Cepheid’s mpox test for emergency use, English Wikipedia adds.

Design has a place in the record too: English Wikipedia says Cepheid won a 2006 Industrial Design Excellence Award for a reagent bead dispenser. The company’s own language is plain and procedural. Its stated mission is built around the phrase “A Better Way”, and its test names follow one pattern, Xpert followed by the target, as in Xpert Xpress Flu/RSV or Xpert MTB/RIF.

For a design guide, Cepheid shows how a brand can be built around one consumable: a cartridge and a desktop instrument, named in one consistent system. Compare Qiagen, another molecular-testing name, and Hologic, another American diagnostics company. For this guide we use a deep teal, ink and a cool bench white with an amber signal, set with a sans, an unofficial interpretation; no product or logo is reproduced.

Keep Cepheid’s identity on hand — save it to a board in the Made Good inspiration library.