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Genalyte to Use $44M Funding Round to Pursue FDA Clearance for Multiplexed Immunoassay Device

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NEW YORK (GenomeWeb) – Having recently closed a $44 million Series C financing round, biotech firm Genalyte aims to use the funds to develop its Maverick biosensor system for rapid, routine testing in doctors' offices.

The San Diego-based company is preparing a clinical study through which it will collect data it will use to submit the device to the US Food and Drug Administration for 510(k) clearance in 2016, Cary Gunn, Genalyte's founder, president, and CEO, told GenomeWeb.

Founded in 2007, Genalyte launched its first Maverick device in 2012. That version is targeted toward academic and drug discovery research, enabling rapid, highly multiplexed immunoassays. The device allows researchers to measure up to 384 different analytes in a single sample or multiplex up to 24 different samples, measuring 16 analytes in each.

As a research instrument, the Maverick device delivered results in a batch format, "geared to take 24 samples at a time and then produce a batch of results two hours later," Gunn said. The new clinical device, on the other hand, will allow doctors to "load a single sample and generate an entire panel of results off that sample in 15 minutes."

The company is not planning at this point to generate novel tests for the platform but rather hopes to position it as an improved platform for existing tests, Gunn said.

"We are focused on providing standard of care testing" but in a more convenient and rapid format that will allow physicians to return test results to patients while they are still in the office, he said.

"We're trying to avoid the time and stress it takes to go across town and have blood drawn and the wait for days before you get your diagnosis back," he added. "Our goal is to shrink that down to a few minutes in the doctor's office." From the doctor's perspective, "instead of having to send a patient out to a separate facility and get the results back and play phone tag with the patient, they can do the test right there and have the results in hand and make a therapeutic and diagnostic decision on the spot," Gunn noted.

The device could also allow physicians to add another revenue stream by letting them keep testing in-house. Gunn declined to comment on the extent to which the company was banking on this motivation as a driver of uptake of the clinical device, but noted that "today the standard practice is to send the test out to a Quest or Labcorp and to not benefit from it."

Genalyte is currently putting together a clinical study in which it will "have doctors operate the instrument and collect data and do a comparison of how it works in their office versus more traditional technologies," Gunn said. He declined to say what assay the company planned to use for its initial FDA submission. He likewise declined to specify any particular assay classes or niches the company saw as places where the company thought it could gain an initial foothold in the market.

"We clearly have [targets in mind], but we aren't ready to tip our hands on that yet," he said.

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.

While Genalyte's current primary focus is on developing the clinical version of Maverick, the company is continuing work on the research side, as well, Gunn said. These activities are housed in its life sciences division, whose main product is a test for patient antibodies indicative of resistance to biologics like AbbVie's Humera (adalimumab) and Amgen and Pfizer's Enbrel (etanercept).

Such drugs can have patient rejection rates of up to 25 to 50 percent, Gunn said, adding that the Genalyte test was used primarily in drug discovery with its main customers being large pharma companies and CROs.

The company has also undertaken research in a number of areas. For instance, in 2012 it was awarded a $500,000 Small Business Innovation Research grant from the National Institutes of Health to develop assays for early detection and monitoring of type 1 diabetes. It also announced in 2013 that it was collaborating with researchers at the University of Colorado School of Medicine to develop multiplexed antigen panels for the detection of the disease.

Also, in 2013 it received another NIH SBIR grant to develop a biomarker panel for profiling tumor antigen-associated antibodies. That work resulted in an initial 39 TAA marker panel that the company composed via literature searches. Genalyte is currently involved in the second phase of this project, collaborating with researchers at MD Anderson Cancer Center, Providence Cancer Center, andWayne State University to investigate how useful these 39 TAA markers are in both monitoring patient response to therapy and early detection of cancer.

The company also this year announced plans to develop a differential diagnostic for Ebola.

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