World's Most Portable Molecular Diagnostics System Unveiled at AACC

Cepheid and FIND have unveiled the GeneXpert® Omni, the world's most portable molecular diagnostics system enabling unprecedented access to accurate, fast and potentially life-saving diagnosis for patients suspected of TB, HIV and Ebola in even the most remote areas of the world.

At just 9 inches tall (about 23 cm) and weighing just 2.2 pounds (about 1kg), the GeneXpert Omni will run the same high quality PCR-based cartridge tests as Cepheid's existing family of GeneXpert Systems. Additionally, the GeneXpert Omni is battery-operated, wireless and web-enabled, setting a new standard in connectivity to transmit instrument and test information in real-time. The GeneXpert Omni is expected to substantially extend the reach of Cepheid's industry-leading technology platform, enabling true point-of-care testing for life-threatening conditions, including tuberculosis, drug-resistant tuberculosis, HIV and Ebola, to be conducted on demand at the patient's location.

"For too long, access to best-in-class molecular diagnostics has been limited by the complexity of the tests and the systems that run them," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "With the GeneXpert Omni, global accessibility to molecular diagnostics is possible for the first time. The system's unprecedented portability means that it can literally go anywhere, and deliver critical diagnostic test results to support disease determination, treatment, and improved patient outcomes."

In partnership with not-for-profit organizations, Cepheid has been leading efforts to broaden access to quality molecular diagnostics with Xpert® MTB/RIF, a test that was endorsed by the World Health Organization in December 2010. Since then, Cepheid has placed more than 4,000 GeneXpert Systems and shipped more than 13 million Xpert MTB/RIF tests as part of its High Burden Developing Country (HBDC) program. The development and initial roll out of Xpert MTB/RIF received essential early support from FIND, the Bill & Melinda Gates Foundation, the U.S. National Institutes of Health, the U.S. Agency for International Development and UNITAID.

"The majority of people in the developing world still lack access to adequate tests for common diseases, and Cepheid's GeneXpert Omni has the potential to be a breakthrough platform on the path to achieving universal diagnosis," said Dr Catharina Boehme, Chief Executive Officer of FIND. "Cepheid and FIND share a commitment to enabling universal access to high quality diagnostics for people in the developing world, dating back to 2006 with the Xpert diagnostic test for MTB/RIF, followed by Xpert HIV and, most recently, the next-generation Xpert MTB Ultra. These innovations show the power of collaboration to positively impact public health and patient lives in developing countries."

"This new point-of-care diagnostic platform has the potential to transform our capacity to detect the world's missing 3 million TB cases," said Dr Mario Raviglione, Director of the WHO Global TB Programme. "Innovation in TB research and development is a critical pillar of WHO's End TB strategy. This ground-breaking, battery-operated technology, which can be used in microscopy centres with limited electrical supply, may bring us one step closer to ending the TB epidemic by 2035."

The GeneXpert Omni was on display at the American Association of Clinical Chemistry (AACC) meeting in Atlanta, Georgia. The system is expected to be available outside the US for emerging market customers in the first half of 2016. At or near launch, the available test menu is expected to include Xpert MTB Ultra, Xpert HIV-1 Qualitative, Xpert HIV-1 Viral Load, Xpert HCV Viral Load, and Xpert Ebola.