Craigavon, NI, 31 May 2007 - Almac Diagnostics had a preliminary Investigation Device Exemptoin (pre-IDE) meeting with the Food and Drug Administration (FDA) to discuss the proposed regulatory pathway for the company's prognostic gene signature for relapse in colorectal cancer (CRC). Senior company officials met with representatives of FDA's Center for Devices and Radiologic Health (CDRH) on April 13, 2007.
Based on the meeting, Almac Diagnostics plans to accelerate the development and clearance of its In Vitro Diagnostic (IVD) utilizing the 510(k) approach to regulatory submission. The company will now finalize the design of the analytical and clinical studies required for US marketing clearance. While there can be no assurance that FDA will ultimately clear the product through the 510(k) premarket notification process, the company has decided to pursue that route of market clearance based on the preliminary discussions with the agency.
The prognostic gene signature was developed entirely from FFPE samples. Designed to help clinicians determine the risk of cancer recurrence in patients diagnosed with stage II CRC, the proposed IDV will be run on a customized microarray. CRC is the second most frequent malignancy in Western societies (1).
Almac Diagnostics, aims to be a global leader in the provision of genomic based solutions for the advancement of patient care. In addition to its own DSA (TM) technology, the company provides an all-inclusive accredited micro-array-based profiling service along with bioinformatics support to academia, biotech and pharmaceutical companies.
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including world leaders in pharmaceutical and biotech sectors. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.
1) World Health Organisation, WORLD CANCER REPORT 2003, International Agency for Research on Cancer, Edited by Bernard W. Stweart and Paul Kleihues.