This story has been updated to include comments from company officials.
Almac Diagnostics will serve as the European reference laboratory for Exonhit's AclarusDx, a blood-based test for Alzheimer’s disease that is run on the Affymetrix GeneChip platform.
AclarusDx is based on a signature of around 130 genes, including some involved in inflammatory and immune mechanisms observed in AD. The company launched the test for research use in 2009 and secured a CE-IVD Mark for the European market in March (BAN 2/16/2010).
Corinne Hoff, director of investor relations at ExonHit, told BioArray News this week that the introduction of AclarusDx has been "gradual" and that the test has been received favorably by French memory centers.
ExonHit said last year that it was in discussions with the US Food and Drug Administration regarding US clearance for the test, and was hoping to gain approval for clinical use in the US by the first quarter of 2012.
Paris-based Exonhit is planning to soon launch it in the wider European market, according to a company official.
Loïc Maurel, chairman of the firm's management board, said in a statement that Almac's "expertise" in molecular biology and its familiarity with Affy's platform played a role in the deal.
"We view the location of Almac Diagnostics in Northern Ireland as an asset for the upcoming roll-out of AclarusDx in Europe," Maurel said. Almac is based in Craigavon, UK.
Under the terms of the agreement, Almac will be the sole laboratory to analyze AclarusDx samples. Centers will send patient samples to Almac, which will process the samples using microarrays. Data will be then analyzed with software developed by Exonhit and the results will be sent back to clinicians to aid them in diagnosing of their patients, the firm said.
Paul Harkin, president and managing director of Almac Diagnostics, said that the agreement will enable Exonhit to "focus on the sales and marketing of AclarusDx," while Almac Diagnostics will "concentrate on the delivery of the diagnostic."
Hoff said that ExonHit has worked with Almac for several months to prepare it for offering the test. "During the technology transfer, Exonhit and Almac took care of the reproducibility of the test between Exonhit research lab and Almac facility and between the Affymetrix research platform and the Affymetrix DX2 system for in vitro diagnostics," she said. "For this purpose we performed a detailed step-by-step bridging study."
Almac will also take part in an upcoming study involving approximately 600 French patients that aims to support the use of AclarusDx "within diagnostic algorithms currently used by memory centers to diagnose AD," according to the firms.
Earlier this year, Almac opened a US Clinical Laboratory Improvements Amendments-compliant laboratory in Craigavon (BAN 4/5/2011). The firm is also developing its own pipeline of oncology-focused, GeneChip-based tests (BAN 6/7/2011).
The company has been offering Qiagen's TheraScreen K-RAS Mutation Test since its CLIA lab opened. Austin Tanney, Almac's scientific liaison officer, told BioArray News this week that the company is open to offering other firm's tests.
"With the infrastructure we have in place, it makes strategic sense for us to offer other companies tests when the circumstances are right," Tanney said. "In the case of ExonHit, there is a strong strategic fit as their assay is based on the Affymetrix Dx2 platform," he said.
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