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:1/6/2017)... 6, 2017  Privately-held CalciMedica, Inc., announced that ... volunteers of a novel calcium release-activated calcium (CRAC) ... Acute pancreatitis, sudden painful inflammation ... but can be very serious.  In severe cases it ... extended hospital stays, time in the ICU and ...
(Date:1/4/2017)... 2017  For the thousands of attendees at this year,s International Consumer ... health and biometric measurement devices and services, will be featuring its new ... in A&D Medical,s special CES Exhibit Suite , the new upper ... the company,s WellnessConnected product platform.  ... ...
(Date:12/22/2016)... Calif. , Dec. 20, 2016  As part of ... 23andMe, the leading personal genetics company, recently released its latest ... . The book focuses on the topics of inheritance ... Generation Science Standards (NGSS) taught in elementary school classrooms in ... in a series by illustrator Ariana Killoran , whose ...
Breaking Biology News(10 mins):
(Date:1/19/2017)... Jan. 18, 2017 BD (Becton, Dickinson and Company) (NYSE: ... that it will host a live webcast of its Annual Meeting ... The webcast can be accessed from the BD ... through Tuesday, January 31, 2017. ... About BD BD is a global medical ...
(Date:1/18/2017)... , Jan. 18, 2017   Boston Biomedical , ... designed to target cancer stemness pathways, will feature data ... napabucasin, at the 2017 ASCO Gastrointestinal Cancers Symposium, held ... . Napabucasin is an orally-administered investigational ... STAT3. i Cancer stem cells (CSCs) possess the ...
(Date:1/18/2017)... ... , ... Executive search firm Slone Partners proudly supports the ... advancement of the clinical trials segment. Hosted in Miami, this conference brings together ... management. , As executive talent specialists in the industries central to clinical ...
(Date:1/18/2017)... ... January 18, 2017 , ... ... funded bio-focused Manufacturing Innovation Institutes (MII). U.S. Secretary of Commerce Penny Pritzker has ... (NIIMBL), and the Department of Defense has announced the award of a new ...
Breaking Biology Technology:
Cached News: