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Gentel Biosciences to Debut Simian Pathogen Detection, Cancer-Testis Antigen Kits Next Month

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By Justin Petrone

Looking to grow its menu of protein array kits, Madison, Wis.-based Gentel Biosciences next month will launch two new assays: one for pathogen detection and another for studying cancer.

Dan Clutter, vice president of commercial development at privately held Gentel, told BioArray News this week that the company plans to add 50 new kits to its product portfolio by the end of the year, as it transforms itself from being a services-oriented business to one that derives the bulk of its sales from products.

The two latest assays, both of which will become available in September, target different customers. The first, the Simian Pathogen Detection Kit, will allow researchers to tell if their non-human primates have been exposed to viruses. The second, the Cancer-Testis Antigen Kit, has been designed for use in cancer vaccine development.

With the Simian Pathogen Detection Kit, Gentel is seeking to move into a market where it feels its protein array platform has advantages over rival technologies, Clutter said. "There are tens of thousands of monkeys used in the US and hundreds of thousands used worldwide," he noted. According to Clutter, researchers typically use "outdated techniques" such as enzyme-linked immunosorbant assays or culturing to determine whether their research primates have been exposed to pathogens.

Using the firm's Gentel Proteomics Multi-System, or GPM, which includes its APiX chromogenic detection platform, researchers will now be able to test non-human primates for the presence of pathogens at a cost of between $25 and $30 per sample, Clutter said. "You only need a couple microliters of monkey serum, and our multiplex assay runs all at once," he said. Since the firm makes most of its own reagents, it is also able to keep reagent costs down, Clutter added.

One potential rival in the market is Luminex. The firm's bead-based xMAP platform currently supports several non-human primate panels that have been adopted by some researchers. Still, Clutter thinks that Gentel has a technology advantage over bead-based systems that require proteins to be coupled to beads. "With our platform, you can take the whole lysate, put it on the array, and detect the immune response of the animal," Clutter said. "I think that for the right price point these researchers will move to a new platform."

Gentel plans to launch the simian chip at the American Association for Laboratory Animal Science in Atlanta in October. Clutter said that Gentel has a simian tuberculosis array in development that will enable researchers to test non-human primates for the presence of the disease and to know how advanced the TB case is. According to Clutter, the TB chip should be available next year.

Cancer-Testis Antigen Kit

Gentel is currently focused on creating arrays for use in two main indication areas: pathogen detection and cancer. In cancer, the firm's newest offering is its Cancer-Testis Antigen Kit, which Clutter said is now available as a service and will become available in a kit form by the end of September.

The chip contains 80 different proteins, many of them discovered by researchers at the Ludwig Institute for Cancer Research in New York, that are thought to be useful in cancer vaccine development. Cancer-testis antigens are a category of tumor antigens with normal expression restricted to male germ cells in the testis and, in some cases, in ovary and trophoblast cells.

In malignancy, though, this gene regulation is disrupted, resulting in CT antigen expression in a proportion of tumors of various types. Since CT antigens are immunogenic and highly restricted to tumors, their discovery has led directly to the development of antigen-specific cancer vaccines, Clutter noted.

"There is a lot of interest from pharma to use these as potential targets for cancer vaccines and so on," said Clutter. "We put down different cancer proteins onto the array, and see what antigens have immune responses."

The internally developed CT antigen kit is just the first of a number of cancer-themed arrays that Gentel has coming down the pipe. Clutter said that Gentel has been working with Protein Biotechnologies, a San Diego-based protein and tissue array company, to bring 10 different tumor lysate arrays to market by the end of this year. Specifically, Protein Biotechnologies' SomaPlex arrays, all of which will run on Gentel's GPM system, will be made available for breast, colon, female reproductive tract, larynx, skin, liver, lung, stomach, thyroid, prostate, bladder, and kidney tumor studies. Gentel announced the deal with Protein Biotechnologies in April (BAN 4/23/2010).

Similar to its agreement with Protein Biotechnologies, Gentel earlier this month launched its APiX Disease Profiling Kit, which is based on Gentel's APiX chromogenic detection platform and Clontech's research-validated Antibody 380 array technology, to help scientists study tumor-associated antigens, compare proteomic and transcriptomic data, and perform target identification and validation. Clutter said that more deals with protein array providers are underway.

"We would like everyone's arrays to run on our system," said Clutter. "There are hundreds of arrays available, and we don't want to create a copy of one that already exists, if it works well," he said.

"We take other companies' arrays and modify the protocol to use our detection technology," Clutter added. He noted that the cost of a kit containing an externally manufactured chip is roughly the same as the original kit.

"It takes a long time to develop assays, and my goal is to have 50 kits on the market by the end of this year," said Clutter. He said that Gentel is in negotiations with companies like Sunnyvale, Calif.-based antibody array maker Full Moon Biosystems and Norcross, Ga.-based protein array firm RayBiotech to make their chips compatible with the GPM. "We are trying to get as many arrays as we can to work on our system," said Clutter.

From Services to Products

Founded in 2000, Gentel Biosciences traditionally earned most of its revenues running services for pharma and biotech partners. According to Clutter, the firm has in the last year and a half been focused on delivering new products to market and approximately 50 percent of Gentel's sales today are from products.

Gentel first launched its GPM system, which supports all these new products, in March (BAN 3/9/2010). The system, which has a US list price of $8,990, includes a chromogenic scanner and enables researchers to run Gentel's slides, competitors' slides, 96-well plates, any size Western blots, tissue sections, and ELISAs.

"Our internal efforts focus on creating arrays that no one else has, and our external effort is focused on making a lot of products available for our users," Clutter said of the firm's strategy. "Essentially, we want our GPM system to be a general proteomics tool for any researchers running arrays, Western blots, tissues, and eventually ELISA, ELIspot, or even colony counting."

Today, most of Gentel's customers buy the GPM for use with arrays, though the "other stuff is nice to have because everyone runs blots," Clutter said. The availability of the system, though, has earned it a new customer group — academics. "Before, customers were predominantly pharmas and biotechs," said Clutter. "We now have a lot of academics using our system."

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