Almac Diagnostic Services Attends Pre-ide Meeting With FDA for Colorectal Cancer Diagnostic Derived from FFPE Tissue Craigavon, Northern Ireland, 28 May 2007
May 31, 2007
Almac Diagnostic Services had a preliminary Investigational Device Exemption (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 Diagnostic Services 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 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 IVD will be run on a customized microarray. CRC is the second most frequent malignancy in Western societies1.
Almac Diagnostic Services, a division of the Almac Group, 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™ technology, the company provides an all-inclusive accredited micro arraybased 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 the pharmaceutical and biotech sectors. The company is headquartered in
Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.
For further information, please contact:
Almac Diagnostic Services
+44 (0) 283 839 5982
+44 (0) 207 344 1304
1 World Health Organization, WORLD CANCER REPORT 2003, International Agency for
Research on Cancer, Edited by Bernard W. Stewart and Paul Kleihues.