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Genalyte Developing Differential Ebola Test for Maverick Chip-based System

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NEW YORK (GenomeWeb) – During the Ebola crisis that swept through West Africa in 2014 and is ongoing in certain countries, efforts at dealing with the virus that has killed more than 8,000 people on the continent have been hindered by an inability to differentially diagnose Ebola from other similar ailments. 

Now, though, Genalyte has developed a test that it says can tell whether a patient has Ebola or one of a number of other similar diseases, including hemorrhagic fevers, with a single drop of whole blood in about 10 minutes. 

The panel currently has been developed to detect and differentiate the Zaire Ebola strain from malaria, Dengue fever, Marburg, and West Nile virus, while other disease indications, including Lassa fever, yellow fever, and HIV are also being developed for inclusion on the panel, which will target a total of 16 diseases, GenalyteP resident, CEO and Founder Cary Gunn told GenomeWeb last week on the sidelines of the 33rd Annual JP Morgan Healthcare Conference in San Francisco. 

Called the Maverick Detection System, Genalyte's technology is a silicon chip-based method, in which blood is flowed over sensors embedded in the chip. The Maverick platform interrogates and reads the chip to detect proteins binding to the sensor in real time. Genalyte software then uses real-time binding measurements to quantify the concentration of proteins and generates a test result. Because there is no need for labeling or washing, the need for a central laboratory to run the test is eliminated, Gunn said. 

While other methods, including those based on PCR, are more effective for the early detection of Ebola, Gunn acknowledged, he said that in some instances, such alternative technologies, which are more expensive and time-consuming, may not be the best option. 

"What we're going for is broad spectrum, multiplexing," he said, adding that his firm's test targets the "differential diagnosis for someone who presents with the acute disease," rather than the screening of asymptomatic populations. 

According to Gunn, such a technology would have had use during the recent outbreak in West Africa. In a report released last week, the World Health Organization noted that one underlying factor that prevented a more efficient response to the outbreak was confusion with other illnesses that presented similar symptoms and diagnoses to Ebola. 

"All previous Ebola outbreaks occurred in countries with a number of long-tenured infectious diseases that mimic the early symptoms of Ebola and help keep the disease hidden," the report said. "The initial symptoms of malaria, for example, are indistinguishable from those of Ebola. … As a further complicating factor, the incidence of Lassa fever — which, like Ebola, is a viral hemorrhagic fever — is uniquely high in this West African region, with Sierra Leone recording the world's highest incidence of cases." 

Genalyte's test, which costs $10, is robust, Gunn said, and does not need to be reflexed to another method for confirmation, adding it is a near-patient test and operates off a workflow that can be CLIA-waived. While access to electricity is needed to run the test, a clean room and liquid handling capabilities are not required, he said. 

Genalyte is currently providing the test to African government agencies for evaluation. Gunn declined to disclose the cost of the Maverick instrument to run the test but said that Genalyte is negotiating pricing for West Africa. The system, he noted, would fit into a lab's broad testing abilities as it can also be used for testing aimed at infectious disease, allergies, and autoimmune disease. 

Genalyte joins a growing number of companies and organizations that have hastened the development of an Ebola test as the Ebola crisis spilled over from Africa and fears were raised when a few cases reached the US. Scientists from the University of Arizona, for instance, are developing a handheld PCR-based device for the rapid detection of the virus. Also, Roche, BioFire Defense, and Altona Diagnostics each received emergency use authorization from the US Food and Drug Administration for their Ebola tests.  

Meanwhile, the Massachusetts Life Sciences Center issued a $1 million challenge grant for the development of a rapid, disposable molecular diagnostic test for the Ebola virus.

Genalyte does not intend to seek an EUA for the Ebola test, Gunn said. 

Genalyte, which was founded in 2007, has been developing its technology for a number of years, Gunn said, and the company has a number of its Maverick systems placed in government facilities. The purpose of its Ebola test is "to be ready for this the next time [an epidemic] comes around," he said, "and also to provide a test for a large number of other diseases that are a lot more common than Ebola. We would be happy if the Ebola test never showed up positive again." 

Beyond Ebola 

The Maverick system, he said, can detect up to 128 diseases from a single finger prick of blood "and then it's about how you bring that to market and … the applications, and infectious disease is one of the obvious applications." While infectious disease tests that run on the system are not available in the US, it is on Genalyte's roadmap, Gunn said. 

Based in San Diego, the privately held firm spent its first few years developing its silicon chip technology, and its first product was an immunogenicity test launched to the pharmaceutical space. Genalyte can multiplex all isotypes of antibodies against the drug, "so we can see the entire spectrum of antibodies, including IgG4." 

IgG4-related systemic diseases are marked by inflammatory cells that cause fibrosis and include autoimmune pancreatitis, Riedel's thyroiditis, and Mikulicz's syndrome. The company's main source of commercial revenues is derived from its pharma business, Gunn said. 

As it seeks to move into the diagnostics space, Genalyte is focused on infectious diseases and autoimmune diseases. Gunn said that it also sees vaccine rejection testing, and immunogenicity testing as possible companion diagnostic opportunities down the road.

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