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Microarray Shops Take Steps to Profit from FDA s PGx Guidance

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With a new FDA guidance, a new sales pitch.

Expression Analysis and Covance have penned a new genomics testing service for biopharmaceutical companies that wish to do genomic microarray testing as part of the drug-discovery process.

The concept behind the service is that through using the new genomic offerings available through EA at Covance, companies will be able to spot genetic vulnerabilities in prospective patients to drugs that they are developing, and nip the problems in the bud before they make it to the marketplace.

The announcement from EA, one of the few gene expression-service providers licensed to use Affymetrix chips, came on the heels of the long-awaited Pharmacogenomics Data Submissions guidance from the US Food and Drug Administration that clarifies how the FDA plans to evaluate pharmacogenomic data during the drug-discovery and drug-development process.

The document also "describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision making," the FDA said in a statement.

EA employs Affy arrays to provide both gene-expression and SNP-genotyping services according to its website.

While the EA and Covance collaboration has been months in the making, according to Steve McPhail, CEO of EA, the service was released in time for the pharmacogenomics guidance, and the duo noted the timing in their press release.

"With the increasing FDA focus on the value of genomic data for evaluating drug submissions, genomic microarray testing is fast becoming a critical element of every biopharmaceutical's clinical trial strategy," Gordon Kapke, vice president of global technical affairs at Covance Central Laboratory Services, said in the statement.

"With this in mind, the combination of Covance's global clinical trial capabilities with Expression Analysis' scientific and industry leadership gives biopharmaceutical firms the assurance of an efficient, high-value approach," Kapke said.

Covance is also selling the service as an "integral" part of its clinical trials offering that should reduce the cost and time of guiding a new drug through rigorous FDA regulatory protocol, according to the statement.

McPhail told BioArray News that while the FDA guidance was a strong selling point, his firm was looking not to capitalize on its release, but to inform its clientele of the benefits of genomic analysis in the drug discovery process.

"We are not using the guidance to market our service," McPhail said. "Rather, Covance and Expression Analysis have informed our combined client base that a validated regulatory compliant solution exists for genomic data submissions."

He added that EA, which was founded in 2001 with the goal of filling the need for microarray services and solutions for biotechnology and pharmaceutical companies, had helped the FDA craft the guidance, which took several years to develop and was delayed numerous times. EA helped develop the guidance document by establishing protocols for electronic data submission, McPhail said (see BAN 9/10/2003).

"Our company has built its infrastructure to support these types of submissions with a goal of facilitating use of microarray-based pharmacogenomic testing in pharmaceutical clinical trials," McPhail said.

"[We] assisted the FDA in understanding how microarray-based genomic data might be used in a regulatory submission by providing the agency with the first electronic submission of this data," he said.

McPhail said that the new service developed with Covance "encompasses everything from sample collection and worldwide specimen logistic capabilities to sample processing to developing appropriate data format and content required for a genomic data submission."

The collaboration can be a component in the ways in which drug makers study potential new compounds, especially with an eye towards toxicity. For example, Applied Biosystems recently announced a collaboration with the FDA to study the toxicity of a class of diabetic drugs, one of which was pulled from the market five years ago for triggering hepatotoxic reactions in some patients.

"We believe that this data holds tremendous potential to improve human health through personalized medicine," said McPhail. McPhail added that EA was already generating pharmacogenomic data in over 25 pharmaceutical clinical trials.

— JP

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