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:4/22/2014)... 21, 2014) -- There are all sorts of signaling ... spread their colorful tails; satin bowbirds build specialized stick ... shiny objects; and European bitterling males show off bright ... a unique method to communicate with others. , ... "Signaling can have profound fitness implications for individuals that ...
(Date:4/22/2014)... HOUSTON (April 22, 2014) Biotechnology scientists must ... for new patent and licensing guidelines, according to a ... Policy. , Published in the current issue of the ... on the June 2013 U.S. Supreme Court ruling in ... Genetics that naturally occurring genes are unpatentable. The court ...
(Date:4/22/2014)... organizations have presented Beaumont Health System with prestigious, ... from both athletic and nonathletic injuries. , ... a $40,000 grant to fund stem cell-based research ... like a ruptured knee anterior cruciate ligament, or ... "An anterior cruciate ligament injury is the over-stretching ...
Breaking Biology News(10 mins):Best practices in communication for the animal world 2Best practices in communication for the animal world 3New patenting guidelines are needed for biotechnology 2New patenting guidelines are needed for biotechnology 3Beaumont awarded grants to study sports-related injury treatment, improve recovery 2
(Date:1/15/2014)... , Jan. 15, 2014  Bill Jacobs Automotive, a group of ... teaming up with the Heartland Blood Center and offering free ... The drive takes place Saturday, Jan. 18 at the Bill ... p.m. (Photo: http://photos.prnewswire.com/prnh/20140115/MN46637 )  The ...
(Date:1/15/2014)... IL (PRWEB) January 15, 2014 Look ... find hard-working items for the lab, from fluid handling ... Guaranteed-in-Stock (GIS)—ready to ship when you order. , ... Peristaltic Pumps , from the L/S® model for precise ...
(Date:1/15/2014)... Jan. 15, 2014 ­ RedBrick Health , a ... technology, today announces that EmblemHealth , the ... company, is now providing the RedBrick Compass health assessment, ... to all of its members. EmblemHealth is among the ...
(Date:1/15/2014)... 15, 2014 More than 5 million ... 1 in 3 seniors will die with Alzheimer’s or ... jaw-dropping figures have shocked many Americans into looking for ... prevent these tragic age-related cognitive disorders. Jonathan Weisman, president ...
Breaking Biology Technology:Join the Bill Jacobs Auto blood drive and receive a free oil change 2Cole-Parmer Begins 2014 with the Release of Preferred Solutions 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 3Biohack Pure Offers 5 Tips for Increasing Memory in 2014 2
Cached News: