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:
TAG: Almac Diagnostics attends pre IDE meeting with FDA

(Date:5/20/2015)... OXFORD, Conn. , May 20, 2015 ... "Company") announces that its wholly owned subsidiary, 3D-ID LLC, ... contractor under Team Battelle for the biometrics technology portion ... Unrestricted Suite Contract from the Department of the Army. ... facial recognition products developed for government, law enforcement and ...
(Date:5/19/2015)... 2015 Research and ... of the  "Genetic Testing Market Outlook 2018" ... , ,A recent report, Genetic Testing Market ... the current and future genetic testing market. ... working principles and types are covered in ...
(Date:5/14/2015)... 2015  Verificient Technologies, Inc., a technology ... remote proctoring, announced a new alliance partnership ... creator of the Canvas Learning Management System ... will benefit from the seamless integration of ... a fully integrated multifactor biometrics behavioral application, ...
Breaking Biology News(10 mins):NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 2NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 3Global Genetic Testing Market Outlook 2018 2Verificient and Instructure Announce Alliance Partnership to Provide Online Proctoring for K-12 and Higher Education Institutions 2
(Date:5/21/2015)... 21, 2015 /PRNewswire/ - RepliCel Life Sciences Inc. ... medicine company focused on the development of autologous ... at the International Society for Cellular Therapy (ISCT) ... tendinosis currently in a Phase 1/2 clinical trial.  ... from 5:30 PM to 7:00 PM local ...
(Date:5/20/2015)... MA (PRWEB) May 20, 2015 This ... history, especially for lawns. US Patented Pearl’s Premium ... for lawns around the country that are coming out ... that addresses a number of major global concerns related ... the “non-grass” grass – the alternative to the standard, ...
(Date:5/20/2015)... CT (PRWEB) May 20, 2015 Agricultural ... 10th anniversary of its acquisition of Tiger-Sul. Since ... Enersul (Calgary Alberta, Canada) in May 2005, H.J. Baker ... to build it into a comprehensive portfolio of product ... strength of H.J. Baker and the innovation of Tiger-Sul, ...
(Date:5/20/2015)... , May 19, 2015 Research and ... the addition of the "Bone Morphogenetic Proteins ... Fusion, Trauma, Reconstructive and Oral - Maxillofacial) - ... Forecast 2014 - 2022" report to their ... market is studied based on the types of ...
Breaking Biology Technology:RepliCel to Present Unique Autologous Cell Treatment for Achilles Tendinosis at International Society for Cellular Therapy Conference 2RepliCel to Present Unique Autologous Cell Treatment for Achilles Tendinosis at International Society for Cellular Therapy Conference 3Breakthrough 4th Generation Low Maintenance Lawn Seed Offers Solution to California Drought 2Agricultural Firm H.J. Baker & Bro., Inc., Celebrates 10 Years Since Acquisition Of Tiger-Sul 2Agricultural Firm H.J. Baker & Bro., Inc., Celebrates 10 Years Since Acquisition Of Tiger-Sul 3Global Bone Morphogenetic Proteins Market Industry Analysis 2014 - 2022 2
Cached News: