HOME >> BIOLOGY >> NEWS
Almac Diagnostics attends pre-IDE meeting with FDA

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).


'"/>

Contact: Claire Eldred
claire.eldred@edelman.com
44-207-344-1342
Edelman Public Relations
31-May-2007


Page: 1

Related biology news :

1. Almac Diagnostics announces pioneering genetic research on ductal carcinoma in situ
2. Almac Diagnostics announces pioneering genetic research on colorectal pre-malignancies
3. Chemical Society Boston meeting, Aug. 19-23, focuses on health, wellness, energy, environment
4. Media events planned for 2007 American Society of Gene Therapy meeting, May 30-June 3
5. SNM capitalizes opportunity to meet with policymakers, regulators at annual meeting in D.C.
6. Data presented at ISHLT meeting confirm RNA analysis can identify rejection in lung transplant recip
7. Developed/emerging market biotech firms convene at largest-ever meeting with global health focus
8. AACR, FDA and NCI announce cancer biomarkers collaborative at the AACR 2007 annual meeting
9. AACR hosts annual meeting 2007
10. Press conferences at the years largest physics meeting
11. Largest physics meeting of the year, in Denver

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/22/2016)... PUNE, India , March 22, 2016 ... new market research report "Electronic Sensors Market for ... Fingerprint, Proximity, & Others), Application (Communication & ... and Geography - Global Forecast to 2022", ... consumer industry is expected to reach USD ...
(Date:3/18/2016)... LONDON , March 18, 2016 ... Established Suppliers of Biometrics, ICT, Manned & Unmanned Vehicles, Physical ... & security companies in the border security market and ... and Europe has led ... your companies improved success. --> defence & ...
(Date:3/15/2016)... -- Yissum Research Development Company of the Hebrew ... Hebrew University, announced today the formation of Neteera ... human biological indicators. Neteera Technologies has completed its first ... ... emissions from sweat ducts, enables reliable and speedy biometric ...
Breaking Biology News(10 mins):
(Date:5/31/2016)... ... ... Doctors in Italy say mesothelioma patients with the highest levels of a ... Mesothelioma has just posted an article on the new research. Click here to ... Italy tested the blood serum, tumors, and lung fluid of 45 mesothelioma patients ...
(Date:5/27/2016)... ... 2016 , ... Weeks after hosting a carpal tunnel syndrome workshop with Dr. ... and founder of the Fitzmaurice Hand Institute, has announced the addition of MRI diagnostic ... technology and only 1 of about 3 currently available in the United States. Developed ...
(Date:5/27/2016)... YORK , May 27, 2016 ... but investors playing in this space know that volatility is ... morning,s featured companies on ActiveWallSt.com: Synta Pharmaceuticals Corp. (NASDAQ: ... ), Lpath Inc. (NASDAQ: LPTN ), and Heat ... and gain access to the technical alerts for these stocks ...
(Date:5/26/2016)... , May 26, 2016 Despite the ... value in this space. Today,s pre-market research on ActiveWallSt.com directs ... Health Inc. (NASDAQ: RDUS ), Cerus Corp. (NASDAQ: ... ARWR ), and Five Prime Therapeutics Inc. (NASDAQ: ... briefings at: http://www.activewallst.com/ On ...
Breaking Biology Technology:
Cached News: