World's Most Portable Molecular Diagnostic System Unveiled
Cepheid and the Foundation for Innovative Diagnostics (FIND) have unveiled a diagnostic tool called the GeneXpert Omni, capable of fast and accurate diagnoses of diseases such as HIV, Ebola and tuberculosis (TB). Weighing in at just 2.2 pounds, the system is portable and offers potentially life-saving point-of-care access to patients regardless of their location.
According to the Cepheid website, the company expects the device to be available for point-of-care usage late in 2016.
Representatives from Cepheid and FIND introduced the device, which is a mere 9 inches tall, at the American Association for Clinical Chemistry meeting. Despite its diminutive size, developers claimed that the smaller system can run the same quality PCR-based cartridges as Cepheid’s existing portfolio of diagnostic devices. Each cartridge is capable of analyzing blood, sputum, tissue, and fecal samples.
Additionally, the Omni can run for 16 hours without a battery recharge and can connect to Cepheid disease databases via Wi-Fi or mobile phone.
“For too long, access to the best-in-class molecular diagnostics has been limited by the complexity of the tests and systems that run them,” said John Bishop, CEO of Cepheid, in a press release. “The system’s unprecedented portability means it can literally go anywhere and deliver critical diagnostic test results to support disease determination, treatment, and improved patient outcomes.”
According to FIND’s website, worldwide infectious disease control and treatment has been limited by the time it takes for samples to travel from the patient to an appropriately equipped lab for analysis. Weather conditions can cause the sample to deteriorate in transit, and the additional time it takes to receive a diagnosis can cost patients days or even weeks of life-saving treatment or quarantine.
Catharina Boehme, CEO of FIND, said that Cepheid and the non-profit have been working together to introduce portable diagnostic equipment since 2006, when Cepheid released the Xpert MTB/RIF, which tests for certain strains of tuberculosis. Since then, they have collaborated on several different new products, including a test for HIV.
According to Fortune, technological advances in miniaturization, wireless capabilities, automation, and cloud data have enabled a shift in the device industry out of the laboratory and into the field.
Although the Omni has been in development for several years, Bishop told GenomeWeb that the device has carefully been kept under wraps. “We’re looking to aggressively enter the point-of-care market,” he said.
Bishop said that Cepheid will apply for regulatory approval to place the device into doctor’s offices and pharmacies for point-of-care service in the United States. Each device would be available for about $2,895, priced low to stay competitive and achieve rapid growth in the global point-of-care market. Fortune noted that the next smallest device in the GeneXpert line costs nearly ten times as much.