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Genalyte Focuses on Rheumatology as It Moves Maverick Platform to the Clinic

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NEW YORK (GenomeWeb) – With $36 million in new funding, clinical testing firm Genalyte is continuing efforts to develop its Maverick Detection System for rapid blood testing in outpatient settings like doctors' offices.

The San Diego-based company this week announced the close of a $36 million financing round led by investors Khosla Ventures and Redmile Group. It also highlighted data from two presentations at the American College of Rheumatology annual meeting earlier this month that found the Maverick platform was able to perform multiplexed testing on whole blood while demonstrating high correlation with conventional testing methods.

Speaking to GenomeWeb this week, Cary Gunn, Genalyte's founder and CEO, said that the company had targeted rheumatology as the first specialty to commercialize the platform for. Genalyte is currently putting together an additional clinical study in rheumatology to follow those presented at ACR, which Gunn said is still in the planning stages.

Founded in 2007, Genalyte launched its first Maverick device in 2012. That version was targeted toward academic and drug discovery research, but the company has since moved towards the clinical market with the aim of using the platform's speed, requirements of small samples, and multiplexing capabilities to position it for in-office blood testing.

The company doesn't aim to generate novel tests for the platform, but rather hopes to sell it as an improved platform for existing test. The idea is that it will allow doctors to get patients their bloodwork results during their visits, enabling quicker treatment decisions and a reduction in the amount of time physicians must devote to follow-up. The device could also allow doctors to add another revenue stream by letting them keep testing in house.

The Maverick system is based on a version of what is known as whispering gallery mode resonance, a phenomenon first observed in the whispering gallery of London's St. Paul's Cathedral, where whispers can be heard throughout the room due to the travel of sound waves along its circular walls.

Genalyte makes use of a similar principle in its device, only using light. Laser light is directed at structures called ring resonators which capture a single wavelength of light, which is then read by a photodetector. Sensors featuring these ring resonators are functionalized with capture agents like antibodies that, when bound to their targets, cause a change in the wavelength of light captured by the resonator that is proportional to the quantity of bound target.

In a 2015 interview with GenomeWeb discussing the company's $44 million Series C round, Gunn said that while clinical applications were its main focus, it was continuing work on the research side, as well. This week, however, he said the company was now "purely focused on diagnostics."

"We look at the early work we did in the research market as helping us get the product perfected, but really, the killer application of our technology is in doctors' offices," he said. The systemcan deliver a large number of test results on whole blood in a near-patient setting with a very easy workflow in 15 minutes, which he said "points to decentralized diagnostics, and that's where we're focused."

Genalyte continues to gather data for a US Food and Drug Administration submission of the Maverick platform and an initial rheumatology panel that Gunn said will consist of assays to around 25 analytes. Last year, he said the company hoped to make a submission in 2016, though he declined to estimate this week when it now planned to do so.

Genalyte is targeting rheumatology as its first area for commercialization due to the relatively high demand for diagnostic testing within the field, Gunn said.

"You have to start somewhere, and it would be a mistake if you took the top 30 diagnostic tests and just went down the list in terms of popularity," he said, "because then, you don't actually solve any one doctor's needs." Once the platform is placed in a physician's office, he explained, itneeds to satisfy a good fraction of that particular doctor's testing needs.

"Rheumatologists do a great deal of diagnostic testing, so it’s a place where [the platform] has a real benefit to the patient and the doctor," Gunn said. He added that in its research, the company has found that rheumatologists average roughly two hours per day of follow-up with patients to discuss their test results.

"That's two hours a day of lost time doing unreimbursed follow-up," he said, noting that a key part of the sales pitch for the Maverick system would be its ability "to shrink that down to virtually zero."

As a result, doctors can be very efficient, he said. "They've got the results in hand when the patient walks in the door, and they can make a faster diagnosis and do a better job, essentially."

In the studies presented at ACR, Genalyte set out to demonstrate that the Maverick platform could perform assays in whole blood, using either venous or finger-stick samples, and with performance equivalent to that of conventional platforms.

In the first study, they used whole venous blood and finger-stick samples on the Maverick and serum samples on Theradig's Connective 10 instrument to measure eight rheumatology autoantibody markers. Comparing across the three setups, they found that the Maverick venous and finger-stick measurements had a correlation of between 98 and 100 percent; the Maverick venous and Theradiag measurements had a correlation of between 97 and 100 percent; and the Maverick finger-stick and Theradiag measurements had a correlation of between 96 and 100 percent.

The second study looked at the correlation between Maverick measurements using whole blood and conventional assays, including the Theradiag Connective 10, immunoblotting, and ELISA. Measuring levels of 13 rheumatology markers in 205 patients with connective tissue diseases (CTDs), including systemic lupus erythematosus, Sjögren’s syndrome, primary antiphospholid syndrome, ANCA associated vasculitis, Raynaud’s phenomenon, rheumatoid arthritis, myositis, and systemic sclerosis, the researchers found correlation of 90 percent or greater for all 13 markers, though in the case of two markers, the Maverick platform provided poorer sensitivity than the conventional platforms. The Maverick platform would not have missed any CTD diagnoses, the researchers noted.

One of the key findings of the studies was the platform's ability to provide results in whole blood, Gunn said.

"That's a really crucial step for the near-patient setting, because making serum takes about 20 minutes and it takes a little bit of equipment, and we've proven we don't need that," he said. "Now it's about expanding the menu and proving that we can deliver test results in a way that makes patients and doctors have a better experience."