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Almac Will File Colorectal Recurrence Dx for FDA OK; Hopes to Sell IVD in '08

NEW YORK (GenomeWeb News) — Almac Diagnostics this week said it plans to meet with the US Food and Drug Administration about starting clinical trials of an array-based colorectal recurrence test it hopes to launch next year.
The Craigavon, UK-based company, which has to date offered arrays for research purposes, intends to launch the assays as an in vitro diagnostic if the FDA clears its 510(k) application.
Almac Diagnostics, previously known as ArraDx, has been an Affymetrix GeneChip service provider for years, and recently began introducing its own line of array research tools called Disease Specific Arrays for colorectal, breast, and lung cancer, all manufactured by Affy on its platform.
According to Almac, the company developed the colorectal cancer gene signature from formalin-fixed, paraffin-embedded samples. It is designed to help clinicians determine the risk of cancer recurrence in patients diagnosed with stage II colorectal cancer.
The firm has been developing the IVD for several years. In September 2006, Almac showed a preliminary 42-gene signature for the indication at Discovery 2 Diagnostics in Boston, according to Almac's website.
Last month, Almac told BioArray News, a GenomeWeb Daily News sister publication, that it will partner with Massachusetts General Hospital to screen colorectal polyp tissue samples in an effort to discover a signature that could help physicians diagnose early-stage colorectal cancer.
Through its parent company, the Almac Group, Almac Diagnostics has “very significant resources at our disposal to deliver the global commercialization of this test," Harkin wrote in an e-mail to BioArray News this week.
Harkin wrote that Almac plans to prepare the test from its laboratory in North Carolina and from its headquarters in Northern Ireland. As it moves forward with clinical trials, the company will probably count on its alliance with Mass General and other partners to provide useful data for the 510(k) submission.

The complete version of this article appears in the current issue of BioArray News.

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