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In U of Colorado Partnership, Genalyte Expands New Diabetes Research Panel

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After announcing last month the release of its type 1 diabetes antigen panel, Genalyte is now planning to develop an expanded version of the research-use assay with collaborators at the University of Colorado's Barbara Davis Diabetes Center.

Continuing an ongoing partnership with researchers from the Davis Center who helped develop the initial assay, called the T1D antigen panel, the company now plans to build additional content into the assay that would allow doctors to monitor whether type 1 diabetes patients show signs of developing additional autoimmune disorders.

Martin Gleeson, the company's chief scientific officer, told BioArray News this week that it initially planned to expand the panel more simply — with additional markers to provide insight into the nature of the autoimmune response in type 1 diabetes. But he said that the company's partners at the Davis Center believed that looking at other autoimmune diseases would be valuable to researchers, and, potentially, to the clinical community.

"One of the things that does happen with type 1 diabetes is that it's quite common [for sufferers] to be prone to a number of other autoimmune diseases," Gleeson said. "And the incidence is sufficient for researchers to be interested in being able to test for a variety of these diseases."

The company's newly-released T1D panel, which runs — along with its other offerings — on Genalyte's Maverick platform, is a tool to identify or confirm the presence of the disease in the context of early detection or monitoring.

The company's Maverick platform is built around an array of "micro-ring sensors," each functionalized with a probe molecule, such as an antibody. According to Genalyte, the system draws a sample from a 96-well plate into a plastic consumable containing the sensors,then reads molecules binding to the sensor in real time.

Genalyte began work on the type 1 diabetes panel with collaborators at the Davis Center in 2012 under a $500,000 Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases(BAN 12/18/2012).

With an expansion to allow researchers to assess the emergence of other autoimmune signals, the panel could also be used to test sufferers and their family members "to monitor for an errant immune response that might indicate that they are slipping toward other autoimmune disease," Gleeson said.

Because Genalyte's array system has the capacity for multiplexing many more markers than the original TD1 panel, such an addition would most likely be an expansion of the current panel rather than an additional stand-alone chip, he added.

Genalyte is also developing panels for a number of other autoimmune diseases. Panels for Sjögren’s syndrome and lupus are also currently available for research use, and development is ongoing on a rheumatoid arthritis test, Gleeson said.

Earlier this year Genalyte also introduced an immunogenicity panel — the MT-ADATM anti-drug antibody immunogenicity assay — for use in the testing of drug candidates to identify potential immunogenicity issues that can reduce the efficacy of the drug or cause harmful effects.

"That is something pharmaceutical companies are interested in being able to monitor, since the FDA has begun to require [this]," Gleeson said. "So we have developed a panel that allows drug makers to be able to test the nature of the antibodies binding to their specific recombinant proteins."

"I think it's a very useful tool, [that] ultimately will yield potential companion diagnostic [opportunities] down the road," he said.

All of Genalyte's assays are currently for research-use only, but the company is currently working to gain 510(k) clearance for its Sjögren’s syndrome test, also called the ENA-6 panel, which simultaneously measures autoantibodies against six of the most commonly tested-for extractable nuclear antigens.

Though the company's new diabetes panel may also have clinical potential, Gleeson said there is currently no timeline for moving it through the FDA 510(k) process as it is doing with the Sjögren’s syndrome test.

"We have not made a final decision," he said. "It's likely — because there is a good amount of interest — that we would look at that. But the timing of moving to the clinic is [still] to be determined," he said.

In the meantime, the company is focused on expanding the T1D panel with the Barbara Davis group, as well as moving forward with other academic partnerships.

Apart from autoimmune diseases, Genalyte is also actively pursuing activities in the cancer biomarker space, Gleeson said. He declined to provide details on the company's developments in this area.

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