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Cepheid to Launch GeneXpert Edge for Decentralized Testing While Omni Remains Delayed

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NEW YORK (GenomeWeb) – Cepheid will launch a new instrument, called GeneXpert Edge, next month for decentralized molecular diagnostic testing. The platform will serve as an interim solution while the launch of the firm's Omni system remains delayed.

Like the in-development Omni, the Edge instrument will be a portable, battery-operated system capable of running all of Cepheid's molecular diagnostic test cartridges.

"The Edge is a system that was designed in light of the delay to the Omni program as sort of a bridging solution that will allow independent battery-operated GeneXpert testing to occur on a single-module system," said David Persing, Cepheid's chief medical and technology officer, in an interview.

The instrument is essentially a single GeneXpert module that is built into a smaller cabinet and will be made available with a tablet computer and a battery that allows for approximately four to six hours of operation, Persing said.

Although some of Cepheid's customers in need of decentralized testing have been known to hack the standard GeneXpert instruments with power converters to enable them to run on car batteries, Persing said, the company has never before sold an instrument that is explicitly battery operated. The Edge will be the first foray into this type of portability.

The instrument and test cartridges will be manufactured in India under a new initiative in order to support the Indian government’s vision of tuberculosis eradication by 2025, the firm said. Peter Farrell, Cepheid's executive vice president of worldwide commercial operations, said in a statement that the company is "hopeful that this portable, easy-to-use testing system will help eliminate delays in TB diagnostics by providing definitive results within hours … facilitating fast and easy last-mile delivery even in the remote villages of India.”

The initiative doesn't mean the instrument is limited to India, however. Persing confirmed that it will be available worldwide and that the firm intends to pursue CE marking for it.

For the Edge, the initial focus will be on offering customers tuberculosis testing. "All the tests in our current menu will run on the Edge system, so they wouldn't be limited to TB, but that is the main focus right now," Persing said. He also affirmed that the Edge will run the firm's HIV viral load and qualitative HIV tests, "which often go together in many parts of the world, especially in Africa, where TB and HIV co-circulate."

Cepheid's MTB/RIF Ultra tuberculosis test launched last year and has since been assessed favorably in published research, particularly with regards to sensitivity. A recent study in The Lancet showed the test was advantageous for detecting TB meningitis, for example. Specifically, the Ultra TB test boosts sensitivity in cerebrospinal fluid by roughly twofold compared to both the current GeneXpert test and culture, Persing explained. "One can go from about 45 percent sensitivity for TB meningitis in clinically defined cases to about 90 percent sensitivity; it becomes a really useful test in that setting just because of that sensitivity difference," he said.

Also, a study from researchers in Spain, published last month in the Journal of Clinical Microbiology, showed the Ultra test had "excellent specificity and high sensitivity" in specimens with few bacteria, also known as paucibacillary specimens. This quality would make the test particularly useful for rapid diagnosis of extrapulmonary tuberculosis, an area where the legacy MTB/RIF test reportedly had some sensitivity issues.

The JCM study also examined a breadth of specimens, such as stool samples, including from pediatric patients, as well as cerebrospinal fluid. And, it supported the idea that Ultra is useful in samples that have mixed microbial flora, like stool specimens, where bacterial culture is challenging, Persing said. "Testing specimens with mixed flora with the Ultra assay may be the best option because of the fact that cultures are often not informative in those specimen types," he said.

Omni timeline

Persing confirmed that the Omni project is ongoing. "We're still 100 percent committed to it, and it is progressing," he said, adding that the firm will have more to say about Omni at the end of this year.

Compared to the Edge system, Omni "will be smaller, and it will have wireless connectivity, which we don't currently have with the Edge," Persing said. Its compact size and the fact that it runs from a smartphone will also provide operational advantages, he added.

The Omni instrument was originally unveiled in 2015 at the American Association for Clinical Chemistry annual meeting. At that time, the firm's CEO, John Bishop, said the system would launch in 2016. He touted the Omni as lighter, cheaper, and potentially having a broader menu than other commercial point-of-care molecular diagnostic instruments. Omni mockups have been featured at the firm's booth during conferences and conventions since, along with videos showing how the system could be used in remote or point-of-care settings.

However, during its Q1 earnings call in 2016, Bishop said the project would be delayed until 2017, and the firm would focus instead on further developing a line of faster test cartridges and CLIA-waived instruments and assays. It has since launched CLIA-waived GeneXpert Xpress systems and faster, waived Xpress versions of its tests for influenza and Group A Strep.

Cepheid was subsequently acquired by Danaher in 2016 for $4 billion, and Danaher CEO Thomas Joyce reiterated an expected 2018 launch date for Omni at the JP Morgan Healthcare conference earlier this year.

Sorting out some manufacturing issues is influencing the Omni delay, according to Persing. "Omni is a new system, and since we don't manufacture our own instruments, we have to engage our manufacturing partners in producing the system," he said. Also, because it is a brand-new system with new characteristics, the challenges for the manufacturer are "unusually demanding," he added.

In a statement, Cepheid also suggested that conversations with stakeholders have led the firm to refine the Omni, additionally contributing to the delay.

"We do think that there is an existing demand for decentralized testing options and the Edge fills that requirement now," Persing said.

Thus, for now, the Edge will be "a good interim solution," he said, for pushing decentralized testing out to places where power is not necessarily completely unavailable, but where it may be unreliable.

"That's the real need right now. Many of the places where this testing is done are places where power may go out on a regular basis or is only available on a semi-regular basis," Persing said.

He also said the Omni and Edge will not necessarily compete with each other. "I don't see any reason why the two can't co-exist," he said. "The Omni will have advantages from a connectivity standpoint, but I think many users will be very happy with what Edge provides them in terms of decentralized testing."

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