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Almac Diagnostics Opens CLIA Lab to Meet Pharma Partners' Needs


This story was originally posted on April 1.

Almac Diagnostics this week announced the opening of its US Clinical Laboratory Improvements Act-compliant laboratory.

The company, headquartered in Craigavon, Northern Ireland, said the new CLIA-registered lab supports its biomarker discovery and development services by "enabling the use of novel tests to stratify and enrich prospective clinical trials." Almac said the lab will support its own development needs as well as those of its pharmaceutical partners.

"We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials, and impact patient treatment decisions," said Paul Harkin, president and managing director of Almac Diagnostics, in a statement. "As such, CLIA is a key necessity for the processing of these samples."

Almac offers partners a suite of Affymetrix-manufactured, Disease-Specific Arrays for breast, ovarian, colorectal, lung, and prostate cancer studies. Last year, the firm introduced its Xcel array, which contains 92,000 transcripts covering multiple disease areas and is optimized for use with formalin-fixed, paraffin-embedded tissue (BAN 6/8/2010).

Almac Diagnostics in August 2010 also launched Biomarkers for Biopharma, a menu of services specifically designed to appeal to drug developers working in the preclinical setting. Almac's Biomarkers for Biopharma services include pharmacodynamic services, markers for selecting study populations, assay development, and a bioinformatics and biostatistics consultancy (BAN 8/3/2010).

The company also has a number of tests in development. The closest to commercialization, ColDx, is for colorectal cancer recurrence. The company said last month that the test is entering its final stages of validation (BAN 3/15/2011).