ATLANTA (GenomeWeb) – Cepheid has announced that it will enter the point-of-care molecular diagnostics market next year with a new platform called the GeneXpert Omni.
The device will use the firm's menu of GeneXpert cartridges, and will be smaller, lighter, and less expensive than other currently commercially available platforms for point-of-care nucleic acid detection.
Cepheid unveiled its plans for the new platform at an analyst event today as part of the American Association for Clinical Chemistry annual meeting, held here this week.
The company has been developing the product for "several years," Cepheid President and CEO John Bishop told GenomeWeb in an interview prior to today's event.
"It has been kept highly confidential — we're looking to aggressively enter the point-of-care market," he said.
The point-of-care testing space includes the CLIA waived developed-world markets — such as physicians offices and pharmacy clinics — as well as remote settings in the developing world that are often short on electricity, technical expertise, and cash. The Omni will be targeted at both of these settings.
The Omni will be ruggedized, with automatic connectivity, and is being developed to utilize cloud data management, called Cepheid Cloud Control, allowing for increased decentralization in diagnostics. It will come with a smartphone to control the platform and full wireless communication, enabling remote analysis of data and pandemic tracing.
Cepheid has already made inroads into the developing world via its high-burden developing country program. It has placed more than 4,000 of its flagship GeneXpert platforms though that program, but the Omni may reach parts of that market that the GeneXpert cannot given its price and size, Bishop said.
The firm is planning to launch its MTB/RIF Ultra assay on Omni in 2016 in these resource-poor areas of the world, which Bishop referred to as emerging markets. Bishop noted that assay is anticipated to have around 95 percent sensitivity on smear-negative culture positive TB from a single sputum specimen. The Omni menu that year will also include the Xpert HIV qualitative and HIV viral load tests, Xpert HCV, and Xpert Ebola. The following year will add HPV and CT/NG, with the full Xpert menu on Omni in 2018.
Cepheid is also developing a line of cartridges called Xpert Xpress that will enable even faster testing than its current Xpert cartridges, Bishop noted.
The US CLIA-waived market menu for Omni will include Flu/RSV, Xpress Flu/RSV, and Xpress Group A Strep in 2015-16; Xpress HPV, Xpress Pertussis, Xpress Group B Strep Ultra in 2017-18; and Xpress CT/NG and Xpress Vaginitis/Vaginosis in 2019-20.
The Xpert Omni platform is expected to weigh 2.2 lbs., be about 9 inches tall, and cost $2,895.
The price point "means you're getting a quality product with all of these attributes at a very low cost, which is going to open up the [developed country] point-of-care market very rapidly, as well as the emerging world market," Bishop said.
Cepheid is able to achieve this low price point due to "the latest and greatest solid-state electronics," Bishop said, adding "We're able to make a good margin here."
The platform will come with a built-in four-hour battery, and an available auxiliary battery "which is very small, plugs into the system, and will give you an additional 12 hours of run time," Bishop said.
The cartridges for the Omni, at least initially, will be the same as those for the original GeneXpert, which Bishop noted have been shown to have high accuracy in a number of clinical evaluations. The Xpress cartridges, which are in development, will run on the platform as well.
The Omni will have active cooling to achieve faster ramp rates for PCR, but the firm is also working on speeding up tests by tweaking the chemistries within the cartridges. It is focused on bringing test times down for other assays, targeting the 30-minute range for multiplex tests like its Flu/RSV, and has developed a Group A Strep test that runs in 15 minutes, Bishop said.
He emphasized, however, that extremely fast time to result might ultimately be less important to patient management in an increasingly digital era.
"Some of our competitors ... [are] playing a marketing game and they think that the race is on with regard to time to result going shorter and shorter," Bishop said. "Realistically, it makes no difference," he added, "Eight minutes versus 15 minutes, it's pointless."
In a slide presentation at the analyst event, Bishop outlined how the Omni stacks up relative to the two current competitors in this market, as well as to its own GeneXpert IV system.
The Roche Liat — a PCR-based platform that can run traditional qPCR assays in 15 minutes, as recently reported — has a price of around $12,000 and weighs about 8 lbs., Bishop noted.
He also compared the Omni to Alere's other platform, the Alere i, which has been previously reported as having a list price of $8,500. The Cepheid comparison estimated Alere i to cost $5,000 and to weigh about 7 lbs., but Bishop also noted that it is isothermal chemistry, which is "not going to be as accurate as PCR," he said.
Cepheid's own GeneXpert platform is $17,500 and weighs 25 pounds.
However, in terms of cannibalizing GeneXpert sales, the Omni is intended to be "a product line extension specifically for the point-of-care market," Bishop emphasized.
"The GeneXpert system is fully scalable — in the US, the number one selling configuration of the system is the GS 16— and we're doing a lot more now with our Infinities in the market ... Those products continue for the hospital and the independent lab market [whereas] the Omni is specifically for point of care, i.e. CLIA waived in the US and the point-of-care markets in the emerging markets."
Regarding regulatory submissions, the firm's Xpert Flu/RSV product is in the process of being reviewed for CLIA waiver at the US Food and Drug Administration. "What we'll do is follow up with the FDA for regulatory approval on the Omni system, and then put the other products through the standard CLIA-waived regulatory procedures as we develop them," Bishop said.
Ultimately, the Omni is expected to unlock at least 100,000 system or site opportunities in the US, and more than 100,000 in remote sites in the developing world, Bishop said.
"We're looking at potentially high volumes, and certainly that helps relative to cost," he said.
The Omni is scheduled to launch in 2016 in the US with the Flu/RSV and the 15-minute Group A Strep tests, and the firm then plans to populate Omni with its sexual health assays. Cepheid will also be looking at "multiple distributors" in the US.