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:3/28/2017)... , March 28, 2017 The ... Hardware (Camera, Monitors, Servers, Storage Devices), Software (Video Analytics, ... Region - Global Forecast to 2022", published by MarketsandMarkets, ... 2016 and is projected to reach USD 75.64 Billion ... and 2022. The base year considered for the study ...
(Date:3/24/2017)... 24, 2017 The Controller General of Immigration from ... Abdulla Algeen have received the prestigious international IAIR Award for the ... Continue Reading ... ... Controller Abdulla Algeen (small picture on the right) have received the IAIR ...
(Date:3/23/2017)... The report "Gesture Recognition and Touchless Sensing Market by Technology (Touch-based ... to 2022", published by MarketsandMarkets, the market is expected to be worth USD ... 2022. Continue Reading ... ... ...
Breaking Biology News(10 mins):
(Date:10/11/2017)... and LAGUNA HILLS, Calif. , Oct. ... Cancer Research, London (ICR) and University ... SKY92, SkylineDx,s prognostic tool to risk-stratify patients with multiple myeloma ... MUK nine . The University of Leeds ... partly funded by Myeloma UK, and ICR will perform the ...
(Date:10/10/2017)... ... 2017 , ... San Diego-based team building and cooking events company, Lajollacooks4u, has ... The bold new look is part of a transformation to increase awareness, appeal to ... period. , It will also expand its service offering from its signature gourmet cooking ...
(Date:10/10/2017)... 10, 2017 International research firm Parks Associates announced ... at the TMA 2017 Annual Meeting , October 11 in ... residential home security market and how smart safety and security products impact ... Parks Associates: Smart Home ... "The residential security market has ...
(Date:10/9/2017)... DIEGO , Oct. 9, 2017  BioTech ... biological mechanism by which its ProCell stem cell ... critical limb ischemia.  The Company, demonstrated that treatment ... amount of limbs saved as compared to standard ... the molecule HGF resulted in reduction of therapeutic ...
Breaking Biology Technology:
Cached News: