At just 2.2 pounds, a compact, battery-powered, DNA-reading medical device will soon be aiding the fight against Ebola, TB, HIV, and other infectious diseases in emerging countries, possibly by the first half of next year.
Device-maker Cepheid (CPHD), of Sunnyvale, Calif., unveiled the machine, dubbed the Omni, at an analysts’ event in Atlanta on Monday night. It stands 9 inches high, 4.2 inches wide, and 3 inches deep, and could easily fit in a backpack.
At the presentation, Chairman and CEO John Bishop said the company will also be applying early next year for FDA permission to use the device for point-of-care service in the United States—meaning that it could be placed directly in doctors’ offices or drugstore clinics, rather than being confined to regulated laboratory environments, as most of the company’s existing products must be. In the U.S., Cepheid will first seek approval to use the Omni for detecting flu and strep (Group A).
The announcement reflects the growing exodus of complex, highly accurate medical devices out of remote laboratories and into the field, closer to patients—a migration enabled by advances in automation, miniaturization, wireless, and cloud technologies.
Point-of-care testing means enormously accelerated turnaround times for results, allowing faster initiation of the correct therapeutic regimen and, in the case of infectious diseases, minimization of the necessity for quarantining. (At the moment, it can take hours to ferry test samples to an authorized lab, even in developed countries. In the field in an emerging country, it takes much longer, and samples can deteriorate if not properly refrigerated.)
Earlier in July, the FDA approved the first point-of-care test for herpes simplex virus, which was designed by Palo Alto-based Theranos, the private company founded and led by Elizabeth Holmes. Theranos hopes that the approval will be the first of more than 120 such authorizations that will be coming down the pike for its entire menu of finger-stick blood tests, which are all analyzed using very similar hardware and software. (Theranos is also seeking FDA emergency use authorization for its DNA-based Ebola test, which I took earlier this month.)
Also in July, Waltham, Mass.’s Alere (ALR) won FDA point-of-care approval—known formally as a CLIA waiver—for a DNA-based test, performed on its 6.6-pound Alere i device, that it says can definitively diagnose strep A in just eight minutes.
The Cepheid Omni comes with a rechargeable, four-hour battery, but an attachable auxiliary battery is said to add another 12 hours of life to the device, giving the product a 16-hour runtime. Results can be relayed to Cepheid’s databases via WiFi or mobile phone.
Cepheid will charge $2,895 for the Omni, Bishop said at the event—almost a tenth of what it charges for the smallest existing version of its GeneXpert line, a 9-pound device that costs about $27,000. (The Alere i costs about $5,000, while Theranos’ analyzers are not for sale; it charges for test services instead.)
All GeneXpert devices, including the Omni, use the same cartridge, according to Bishop, which can accommodate blood, sputum, tissue, and fecal samples. Cepheid’s other GeneXpert devices, which all use the PCR method of amplifying and detecting nucleic acids, are currently used to diagnose 22 infectious diseases worldwide, and the company is now moving into oncology as well, Bishop said in an interview with Fortune.
Though Cepheid’s existing FDA emergency use authorization (EUA) for its Ebola test requires the use of blood drawn by venipuncture—that is, a needle in the arm—Cepheid says it expects to receive European Commission approval (known as CE IVD) next month for mouth swab and finger-stick blood versions, as well. (Because of the danger of transmitting potentially lethal infection via accidents involving long needles, many consider finger-stick Ebola tests safer than venipuncture for healthcare workers. Theranos is also currently awaiting an EUA for its Ebola test which, like almost all its tests, is designed to be used with blood drawn by finger-stick.)
Cepheid said that the development of the Omni and predecessor devices has been backed by the international non-profit FIND (Foundation for Innovative New Diagnostics), the Bill and Melinda Gates Foundation, the U.S. National Institutes of Health, the U.S. Agency for International Development, and UNITAID (an affiliate of the World Health Organization).
Correction: An earlier version of this article incorrectly said Cepheid soon expected to get FDA emergency use authorization for its mouth swab and finger-stick blood Ebola tests; in fact it expects to get European Commission approval for those tests. I regret the error.
