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GenTel Looks to Stake Claim in Multiplexed Coagulation Market; New Assay Due in Q1


SAN DIEGO -- With a new name and an old partner, GenTel BioSciences expects to roll out a multiplex immunoassay for coagulation research later this quarter, hoping to play in an underpopulated niche market and prove itself as a catalog array provider.

The announcement comes at a time when GenTel is repositioning itself from a slide and microplate company to one that offers content arrays. The company, formerly GenTel BioSurfaces, renamed itself earlier this month to reflect this change (see BAN 1/10/2006).

Following a presentation at Cambridge Healthtech's PepTalk conference, held here last week, Robert Negm, GenTel's vice president, told BioArray News that a chip that can enable researchers to study coagulation, or "coagulomics" as he calls it, could help GenTel brand itself as a content array provider.

Negm said that the array, called the Coag Chip, measures 10 analytes simultaneously from the same sample and has been designed to work as an assay on Decision Biomarker's MultiMark Express instrument, which will be released commercially later this year. The assay can also work on other platforms, Negm said.

According to Negm, the content for the Coag Chip was developed with a University of Vermont spin-off company called Haematologic Technologies, and may "aid hematologists to identify molecular signatures in human plasma that can be used collectively to help identify risk assessment for early detection and risks of recurrences of thromboses."

"Our whole strategy has been to not make any
chips that you can get somewhere else in the marketplace. What's the point of making another 'me too' product?"

Negm also said that GenTel may find a market for the Coag Chip in lead compound discovery programs. "By measuring the various quantities of coagulation-related proteins simultaneously, [the chip] will assist pharma's drug development scientists to monitor the benefits of therapy early in the course of treatment using a surrogate endpoint as an alternative to a clinical endpoint in clinical trials," Negm wrote in an e-mail to BioArray News. "The Coag Chip will likely end up allowing clinicians to treat patients individually in the scope of their hemostatic profile," he wrote.

But why focus on coagulation? Negm said there were financial and strategic opportunities for developing a research tool that addressed the need for multiplex coagulation research.

"In terms of clinical importance, for whatever reason, no one has been multiplexing coagulation factors," Negm explained. "The esoteric market alone [for thrombosis and hematological tools], where it's used in basic research, is a $200 million market by itself, never mind the diagnostic market," he said. "We are selling a research use only product, but just to make the research tool is worth it for us."

BioArray News could not independently verify Negm's assessment of the market size for such an assay. However, these kinds of immunoassays are offered at testing centers across the US, from larger organizations like the Mayo Clinic in Rochester, Minn., to more specialized testing sites like Esoterix Laboratory Services in Austin, Tex. And the market for array-based coagulation assays remains open. It has been more than three years since Tm Biosciences launched an array-based kit for coagulation, the Tag-it Mutation Detection Kit (see BAN 12/13/2002).

"Our whole strategy has been to not make any chips that you can get somewhere else in the marketplace," Negm said. "What's the point of making another 'me too' product?" he said last week. "There's probably about six companies out there that make a TH1/TH2 chip with the same old human and mouse cytokine antibodies and I don't want to do that. What's the point?"

"This gives us a first-to-the-market advantage and we don't have to worry about another multiplex company just grabbing the same content and competing with us," Negm said.

The Coag Chip measures 10 analytes simultaneously from the same sample, and provides researchers with a "molecular signature that can be used in identifying who is at risk in getting thrombosis," Negm said. It also can be used to develop a "hemostatic profile that can be associated with the likelihood of recurrence of thrombosis" after the patient is treated with anti-coagulant drugs.

"This might be one of those tools that help diagnostic researchers identify a panel of markers to assess the risk of the occurrence of this disease," Negm said.

GenTel is considering selling the Coag Chip kit as a one-slide assay with four slides per kit, with availability in the firm's PATH HTS 96-well format. Negm said that the company is trying to keep the price below $1,000 per kit, but hasn't decided on pricing.

DBI and Future Apps

Although GenTel now has the content, courtesy of Haematologic Tech, and the surface chemistry, it does not sell instrumentation for the assay. However, it has paired with Decision Biomarkers to market the Coag Chip assay together with DBI's platform, the MultiMark Express.

The two companies held a joint event at PepTalk last week, and have a long standing collaboration. DBI originally licensed the surface chemistry to GenTel to launch the company's PATH slide portfolio, while DBI has earned its sole revenue since it was founded as a distributor for PATH slides.

Now the two companies are pairing GenTel's first assay with DBI's first instrument in order to provide customers with a possible format for running the experiments.

At the event at PepTalk, Peter Maimonis, DBI's vice president of biological research, said that MultiMark Express, a small bench-top reader designed to read multiplexed immunoassays in the proteomics field, would be launched in June.

Jeanne Cardona, the Waltham, Mass.-based company's vice president of sales and marketing, confirmed that the MultiMark system is in beta testing at the moment and will be launched in June. She also said that, just as DBI changed its name last August from Clinical Microarrays (see BAN 8/17/2005), MultiMark will get a new name in June.

"MultiMark Express was the name of our beta instrument; [the] new instrument will be called the Avantra Q400 Biomarker Workstation," Cardona told BioArray News this week.

Negm said last week that GenTel is considering developing more immunoassays that would work on the MultiMark/Avantra Q400 system.

"We are looking down the road this year to develop assays for them to put into their instrument. Obviously the first place to start will be this coagulation panel," Negm said.

Specifically, GenTel is working with Brian Haab of the Van Andel Research Institute "to transfer his technology [for profiling oscillation of cancer serum biomarkers] to our lab to do some test marketing," Negm said.

Haab joined GenTel's scientific advisory board in July 2005. He told BioArray News at the time that he had been using GenTel's platform to develop applications that would use blood samples to diagnose pancreatic or prostrate cancer (see BAN 7/13/2005).

"We are using the PATH slide for antibody array work," Haab told BioArray News in July. "We have a few different formats in use, mainly applied to serum studies in pancreatic and prostate cancers," he said.

— Justin Petrone ([email protected])

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