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Decision Biomarkers to Launch Flagship Automated Biomarker-Evaluation Tool in Q2


After securing $7.6 million in its second round of Series A financing, which closed last week, Decision Biomarkers is getting ready to launch its first product: an automated system for evaluating up to 40 protein biomarkers for pharmaceutical customers.

Decision Biomarker claims that its flagship product is the first tool on the market that offers full automation for assaying biomarkers.

"In the market of biomarkers, when you look at the platforms available, they are manual assays," said Roger Dowd, president and CEO of Decision Biomarkers. "We believe that the market has matured to the point that it would benefit from an automated assay. We're very differentiated from any other assay."

The product is currently called the MultiMark Express, but its name will be changed to the Avantra Q400 Biomarker Workstation once it is launched in about four months. According to Jeanne Cardona, vice president of marketing and sales, the product enables researchers to see biomarker results in 45 minutes to one hour.

"The user injects a sample, hits the run button, and walks away," said Cardona. "An hour later, results for the assay are compiled."

While a number of firms are developing protein array chips for use in the diagnostics market, Decision Biomarkers will target the Avantra Q400 Biomarker Workstation to the drug-development market because that sector is embracing multiple biomarkers more than the diagnostics community, Dowd said. But will the market bite?

"In the market of biomarkers, when you look at the platforms available, they are manual assays. We believe that the market has matured to the point that it would benefit from an automated assay. We're very differentiated from any other assay."

Compared with competing assay systems, such as Luminex's multiplexed bead system, or Pierce SearchLight's 96-well plate array, Decision Biomarkers' assay system seems easier for the user, said Steven Bodovitz, principal of the biotech consulting company BioPerspectives, who conducted an extensive study on protein arrays in 2004.

"This is certainly a more fully enclosed, single system," said Bodovitz. "My reaction is that this would be one of the easiest of the multiplex antibody assay technologies. You load your sample in, and it goes."

Luminex's system is semi-automated; there are still some manual steps that must be performed in the beginning to add samples to beads, Bodovitz said.

Luminex did not return calls for comment.

Though Decision Biomarker's system may be easy to use, it remains to be seen if it works well in terms of sensitivity, quantititation, and accuracy, Bodovitz cautioned.

Though Luminex's system can multiplex up to 100 proteins, it is rare to find anybody that uses the system for more than 20 proteins at a time because increased multiplexing leads to cross reactivity, Bodovitz pointed out.

Decision Biomarker's system uses a customized biochip that holds up to 40 biomarkers at a time. The chip uses a nitrocellulose-based substrate to get the biomarkers to stick to the slide.

"Doing 40 is a big number," said Bodovitz. "Multiplexing is never trivial. The hard part is getting it to work well."

Decision Biomarkers' customized chips cost about $130 for up to 40 analytes, while the biomarker assay instrument costs about $40,000, said Cardona. It takes about four weeks to create a customized chip, and to optimize an assay, she added.

Decision Biomarkers currently has two beta testers for its product, Cardona said. One is a pharmaceutical company, and the other is a contract laboratory. Cardona declined to reveal the identities of the beta testers, saying that they "don't want to align themselves with one particular company."

Aside from being relatively easy to use, an automated biomarker assay system also reduces variability between assays, thus making the assays more reliable, Cardona said.

"With most assays, if you ran it twice, you'd see significant variances, because there's so much user interface," said Cardona. "With our system, there's no liquid handling that typically occurs during the assay process. Our instruments control the entire assay — temperature, rate, antibodies are all controlled by the instrument."

As for the company's decision to market the Avantra Q400 Biomarker Workstation to the drug-development community rather than to diagnostic researchers, Dowd said "it's a question of validation. In the diagnostics market, the amount of validation you need to convince clinicians to rely on the data [of multiple biomarkers] is quite high, and the US Food and Drug Administration does a good job in ensuring that that validation is adhered to because that data is used for the diagnosis of a patient."

However, in the drug development market, "there's more flexibility in validation, because the information gleaned from biomarkers is usually used in management decisions, not in the diagnosis of a patient," he said.

"The user injects a sample, hits the run button, and walks away," said Cardona. "An hour later, results for the assay are compiled."

A drug developer might use Decision Biomarker's technology to test the effect of drug treatment on certain biomarkers. "You'd run the same biochip before and after a patient has been treated with a drug, and do comparisons," said Cardona.

Decision Biomarkers was founded about four years ago with two people, and has since expanded to employ about 30 people, Cardona said. The company is based in Waltham, Mass.

Last year, the company closed its first round of series A funding with about $7.5 million. The $7.6 million in second-round financing will be used to support early adoption and sales of the Avantra Q400 Biomarker Workstation, Cardona said.

Both the first and second round of financing included investments from Oxford Bioscience Partners, Rock Maple Ventures, Fletcher Spaght Venture Partners, and a group of individual investors led by Jean "Coco" Montagu, the chairman of Decision Biomarkers.

Decision Biomarkers has a co-marketing agreement with GenTel BioSciences, which helped the company with the back end of the development process for the customized biochips, Cardona said. GenTel is helping to sell the new technology system, as well as helping to make the custom chips.

— Tien-Shun Lee ([email protected])

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