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:8/3/2015)... Synaptics, Inc. (Nasdaq: SYNA ), the ... members of the executive management team will present to ... Leadership Forum on Tuesday, August 11, 2015 at 1:00 ... the Sonnenalp Resort in Vail, CO. ... information. An audio webcast of the event will be ...
(Date:7/31/2015)... de julio de 2015 BGI llevará a cabo ... del 22 al 25 de octubre de 2015, en ... conferencia celebra su décimo aniversario este año. Desde su ... de las reuniones anuales más influyentes del mundo en ... las conferencias científicas más dinámicas, entusiastas y amenas. ...
(Date:7/31/2015)... juillet 2015 La 10e Conférence internationale ... organisée par le BGI du 22 au 25 ... en Chine. La conférence célèbre son ... 2006, l,ICG est devenue l,une des réunions annuelles ... « omiques » et c,est aussi la plus dynamique, la ...
Breaking Biology News(10 mins):La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 3La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 2La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 3
(Date:9/2/2015)...  Neurotech Pharmaceuticals, Inc., announced today the first ... 2 clinical trial of NT-503 Encapsulated Cell Therapy ... choroidal neovascularization secondary to age related macular degeneration ... growth factor (VEGF) receptor protein continuously produced by ... proof-of-concept study will evaluate NT-503 ECT as a ...
(Date:9/2/2015)... 2, 2015 BioLight Life ... the "Company"), a firm that invests in, manages ... diagnostics, announced today that presentations highlighting its IOPtiMate™ ... delivered at the Ophthalmology Futures European Forum and ... Cataract & Refractive Surgeons ("ESCRS"), both taking place ...
(Date:9/2/2015)... ... September 02, 2015 , ... ... will be attending Pharma Ed Resources upcoming educational seminar and training session ... leading speakers, this timely conference will provide Updates & Case Studies on the ...
(Date:9/1/2015)... Swecure, ein Biotechnologieunternehmen, ... Entwicklung neuartiger Therapien für Störungen des Immunsystems ... konzentriert, erhält vom US Patent and Trademark ... patentiert wird. Das Medikament basiert auf einem ... und Entzündungen vorbeugt.   Das Medikament, ...
Breaking Biology Technology:Neurotech Announces First Patient Enrolled in Novel Anti-VEGF Encapsulated Cell Therapy Study 2Neurotech Announces First Patient Enrolled in Novel Anti-VEGF Encapsulated Cell Therapy Study 3Neurotech Announces First Patient Enrolled in Novel Anti-VEGF Encapsulated Cell Therapy Study 4Presentations to Highlight BioLight's IOPtiMate[TM] System at Upcoming European Ophthalmology Conferences 2Presentations to Highlight BioLight's IOPtiMate[TM] System at Upcoming European Ophthalmology Conferences 3Whitehouse Laboratories to Participate in Pharm Ed Resources Extractables, Leachables, & Elemental Impurities Educational Seminar 2Whitehouse Laboratories to Participate in Pharm Ed Resources Extractables, Leachables, & Elemental Impurities Educational Seminar 3Das Patent von Swecure zur Verhinderung von Allergien bei Kindern wird in den USA zugelassen 2
Cached News: