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Gentel Prepares to Launch APiX Platform, Assays in H1 as It Looks to Build Services Arm

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Gentel Biosciences, a nine-year-old privately held protein-array firm based in Madison, Wis., is planning to launch assays for carbohydrate and protein biomarker profiling this month, and to debut a new high-throughput microarray platform called APiX in June, according to a company official.

Dan Clutter, Gentel's new vice president of commercial development, told BioArray News last week that the firm believes its APiX assays and platform will be attractive to both its core pharma customers, who are interested in adding new assays to compound screening programs, and to new academic customers, who might be attracted to the system's lower cost.

Gentel's APiX GlycoBiomarker Profiling Array Kit provides a method for multiplex profiling of glycan patterns on glycoproteins. The kit enables the characterization of disease-associated glycan alterations, the identification of new biomarkers, and the analysis of factors that regulate glycan structures, according to Gentel.

"Carbohydrates are really important in terms of receptors and cells and how they react," Clutter said of the first assay. "There has been no mechanism to look at it in the past; it's been an ignored field," he said. "The pharmas are especially interested [in the assay] because they have a ton of markers and they can take it to the next level to test reactions with carbohydrates," he added. "It's another technology they can use to narrow down their potential target list."

While homebrew carbohydrate arrays have been described in many publications, there are only a handful of companies that sell catalog carbohydrate chips. Potential competitors for GenTel include Gaithersburg, Md.-based KamTek, which sells a line of glycoarrays for carbohydrate studies.

The APiX GlycoBiomarker assay currently runs as a service on Gentel's fluorescence-based PATH protein array platform, which enables researchers to process up to 64 individual samples on the company's PATH ultrathin nitrocellulose film slides.

According to Clutter, Gentel in June will introduce its standard 16-plex APiX arrays, as well as a 96-well APiX protein array microarray platform, which the company claims offers higher signal-to-noise ratios for multiplex protein-microarray applications, including quantitative multiplex immunoassays, single-capture antibody arrays, multiplex serological assays, and biomarker profiling. A 96-well version of the PATH system will become available at that time too.

Last year, Gentel secured licenses to two components of the APiX platform, laying the groundwork for its launch this quarter. In June, Gentel licensed Eppendorf's Silverquant colorimetric-detection technology for use in its protein-array assays. Silverquant is a patented method in which gold particle-enhanced silver crystal deposition is used to detect and quantify microarrays (see BAN 6/3/2008).

In August, Gentel licensed technology from Agnitio Science and Technology of Hsinchu, Taiwan, covering the use of an ultrasonic coating used to produce nitrocellulose films. Gentel said it would use the ultrasonic coating technology to manufacture "highly reproducible" nitrocellulose protein-microarray slides (see BAN 8/12/2008).

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"This technology not only gives Gentel the flexibility to produce a variety of slides that are optimized for different applications, but it also increases our ability to ramp up production significantly while substantially reducing cost of goods, a must if we are to deliver low-cost, effective products to our customers, CEO Alex Vodenlich told BioArray News at the time.

"We have the PATH-based system, which is already out there, but everything that has been done on the glass slides can be moved to the colorimetric slides," Clutter said last week. He said the company plans to launch the APiX assays first, and then upgrade them to the APiX system later.

According to Clutter, both the Eppendorf and Agnitio licenses will enable Gentel to charge less than other companies for APiX. He estimated that the scanner component of APiX, for example, would cost around $1,500, versus the prices of other scanners on the market sold by array vendors and tools companies that can cost up to $70,000, albeit with various differences in functionality.

"APiX takes the scanner cost out," Clutter said. "Our scanners will literally cost a thousand dollars or less, which is mindboggling if you come from the fluorescence world where scanners are going for a $70,000," he said.

Clutter said Gentel hopes the APiX system will attract more academic customers to the company, which has traditionally seen most of its revenues come from pharma and biotech customers. "We are definitely seeing more interest from academics because of the low-cost detection system," he said. "It opens the door for us to a much broader market."

'Broader Profiling Strategy'

While Gentel prepares its GlycoMarker assay for market, Clutter said that four assays it acquired from GlaxoSmithKline in early 2007 are farther along in the pipeline.

Gentel bought the protein array R&D unit from GSK, a major collaborator, in March of that year, and through the acquisition gained an R&D development team led by Anna Astriab Fisher, a principal scientist in GSK's technology-development department, who joined GenTel as vice president of assay development in November 2006, as well as four arrays: a chip for human cytokines, a chip for mouse cytokines, a metabolic chip, and a matrix metalloproteinase chip (see BAN 3/7/2007).

While these assays are available as services, Gentel had originally hoped to launch the GSK assays as commercial products that year. Clutter this week said that the company is still optimizing the assays and that they may never see a commercial launch in their current forms.

"Though GSK is a pharma and are very good at what they do, R&D standards are not what you need for commercialization," he said. "We found that these assays needed a lot of optimization for commercialization, so that is where they are for now."

In the past, Gentel had also planned theme arrays for deployment on its platform, including a chip for studying coagulation and an allergy chip for diagnosing respiratory allergies. Clutter said that Gentel has now reconsidered those programs, and is instead looking to develop theme arrays through research programs with partners.

"We decided to go after a broader profiling strategy," Clutter said. "People can research any disease, come to us, and say, 'Profile this and tell us which markers are important,'" he said. "It is better to go fishing first, screen lots of customer samples, do the profiling, and then move to the quantitative stuff."

As part of Gentel's "broader profiling strategy," the company will be adding to the services component of its business. Clutter said that Gentel's services currently include custom printing, assay development, and sample processing.

"Gentel has always been offering services, but in the past half year we have reorganized the R&D group, the manufacturing group, and our commercialization group to focus on taking the interesting stuff we have been working on, optimizing it and bringing it to the market," Clutter said. "We will use our experience and when we go to market we will have products that work in anybody's lab, so that your 10-year-old daughter can run the protocols," he said.

Last May, Gentel announced that it had acquired "multiple" LS Reloaded scanners from Tecan to support an expansion of its services business. Clutter said that Gentel plans to make similar investments this year.

"We will add more people — including assay developers, project managers, and lab technicians — and equipment as the business grows," Clutter said. "The 96-well format is amenable to automation, and we already have robots to run them, so the scale-up will be pretty straightforward."

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