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Genalyte Developing Early Detection Diabetes Test, Planning 2013 FDA Submission for Autoimmune Panel

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In addition to seeking research customers interested in using its platform for multiplex analysis, Genalyte is now accelerating development of its own internal content around autoimmune disease and diabetes. The company recently secured funding for a project to create and validate an early-detection type 1 diabetes test, and plans to submit an autoimmune panel covering Sjögren’s syndrome, lupus, and related disorders for regulatory approval next year.

Genalyte announced last week that it had been awarded a $500,000 Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases to develop assays for the early detection and monitoring of type 1 diabetes.

The diabetes test will be developed using the company's Maverick Detection System — a silicon photonics-based, multiplex protein and antibody array system — in collaboration with the Barbara Davis Diabetes Center at the University of Colorado School of Medicine.

Martin Gleeson, Genalyte's chief scientific officer, told BioArray News that the Davis center has thousands of well characterized retrospective samples, which the company hopes to use to identify and validate antibody signatures that can be used to identify patients before they fully develop type 1 diabetes. The hope is that earlier detection can help clinicians stave off disease progression.

"The intention is first to do a retrospective study, to identify the pattern of autoimmune response prior to the actual manifestation of type 1 diabetes," Gleeson said. "Once we develop that pattern, it can then be applied in a prospective study to identify those patterns in patients before they fully demonstrate or manifest the disease."

Cary Gunn, Genalyte's CEO, told BAN that Genalyte will spend the first six months of the new grant developing the assay and doing preliminary testing. Then the group will put together a full retrospective study, he said.

"That would be the completion of that grant," Gunn said. "But we'll also then work with our collaborators to identify what would be the appropriate data in order for them to get a readout to provide a clinician with information that they can actually act on, so there may be some secondary work beyond that," he added.

According to Gunn, Genalyte's silicon photonics technology allows analysis without any sample preparation. Users can "perform a complicated and high-plex panel of assays in less than 15 minutes, adding serum or whole blood directly with no processing," he said.

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

Earlier this year, the company began offering a custom spotting service that allows customers to purchase a preloaded chip, like Genalyte's autoantibody arrays, but constructed using their own design and menu of proteins or antibodies.

Gunn said about two-thirds of the company's customers require their own proprietary content. "The custom spotting is one way we are able to develop that for them," he said.

On the internal diagnostics development side, in addition to the diabetes project, Genalyte has also been developing an autoimmune disease test, which it intends to cover a broad range of disorders. Currently the panel is limited — to systemic lupus erythematosus, Sjögren’s syndrome, and a few associated diseases — and is available for research use only. "We will be expanding that into other autoimmune areas, like rheumatoid arthritis … over time," Gunn said.

Gleeson said the company hopes to submit the current content for US Food and Drug Administration clearance next year, as well.

Earlier this year Genalyte raised $11.8 million in a Series B financing round. Gunn said the company has been using that money to support commercialization of the Maverick platform for research, while also developing a clinical version of the platform to run diagnostic assays.

According to Gunn, Genalyte is planning to release this diagnostic instrument at the end of 2013. He said the company is still working with the Maverick platform for development of the diabetes assay and autoimmune test, but the eventual plan is to transition "clinically relevant" programs to the other platform when the company seeks regulatory approval for these tests.

Gleeson also said the company's technology is by no means limited to autoimmune disease applications. He said Genalyte is also investigating cancer biomarker detection, both in house and with interested outside partners, but declined to provide further detail.

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