Navigation Links
QIAGEN Completes Second U.S.Submission for Companion Diagnostic to Guide Treatment Decisions in Colorectal Cancer
Date:8/5/2011

the way medicine is practiced. Our leadership in enabling and accelerating this transformation will continue to be a dynamic growth driver for QIAGEN."

QIAGEN's PMA submissions follow the FDA's issuance of guidelines for the co-development and approval of drugs and associated companion diagnostics on July 14, 2011. The agency encourages the use of personalized medicines that rely on approved or cleared companion diagnostic devices. Without approval or clearance, the FDA sees tests as a potential public risk due to lack of adequate proof of accuracy and of well-controlled manufacturing processes. The guidelines recommend that in future drug labeling bears a reference to a type of FDA approved or cleared test so that only an approved or cleared companion diagnostic could be used to guide treatment decisions. QIAGEN is a pioneer in developing the PMA approach for the approval of companion diagnostics such as the KRAS assays.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical
'/>"/>

SOURCE QIAGEN N.V.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Webcast of QIAGEN N.V.s (Nasdaq: QGEN) Fourth Quarter and Year-End 2009 Financial Results Call Set for February 9
2. QIAGEN Acquires ESE GmbH
3. WuXi AppTec and QIAGEN Enter into Partnership Agreement for Molecular Biomarker Development
4. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
5. Study Finds QIAGENs HPV Test Offers Greater Long-term Protection From Cervical Disease Than the Pap
6. Webcast of QIAGEN N.V.s (Nasdaq: QGEN) First Quarter 2008 Financial Results Call Set for May 6
7. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
8. QIAGEN N.V. (Nasdaq: QGEN) Invites You to Join Its Third Quarter 2007 Earnings Conference Call on the Web
9. Vycor Medical, Inc. Completes Final Close on Equity Capital Raise
10. Global Pharm Holdings Group Completes Acquisition of Pacific Asia Pharm Investment Group Co., Ltd.
11. Vessix Vascular Completes $23 Million Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2015)... 2015  Holographic Optical Technologies of Augusta, ... medical imaging, is entering the world of consumer electronics ... April 20 th , 2015, the campaign will introduce ... and 22-inch displays will allow consumers to view fully ... In addition to the two displays, the company will ...
(Date:3/27/2015)... -- Victoria Vein & Surgery Clinic is the only clinic offering ... Victoria, Texas . The clinic specializes in ... treatments for a variety of medical and cosmetic conditions. High-end ... services for their patients. Since adding laser tattoo removal, Victoria ... residents get rid of their unwanted ink. ...
(Date:3/27/2015)... 27, 2015   Cypher Genomics, Inc., ... data showing that, compared to a panel of ... highly equivalent interpretations of whether certain genetic abnormalities ... in a fraction of the time. Cypher,s Mantis ... comprehensive genetic analysis in non-invasive prenatal testing (NIPT) ...
Breaking Medicine Technology:Holographic Optical Technologies brings cutting-edge holograms to consumer market through upcoming Kickstarter campaign 2Holographic Optical Technologies brings cutting-edge holograms to consumer market through upcoming Kickstarter campaign 3Victoria Vein And Surgery Clinic Uses Advanced Astanza Duality Tattoo Removal Technology 2New Data at ACMG Shows Cypher's Software Can Automate Interpretation of Genetic Variants to Advance Non-invasive Prenatal Testing 2New Data at ACMG Shows Cypher's Software Can Automate Interpretation of Genetic Variants to Advance Non-invasive Prenatal Testing 3
(Date:3/28/2015)... York, NY (PRWEB) March 28, 2015 ... that offers urgent care in Manhattan, recently commemorated its ... care facility in Manhattan. In addition to 24-hour urgent ... ER facilities. , At this time, Emergency Medical ... for abdominal pain, asthma, chest pain, eye injuries, ear ...
(Date:3/28/2015)... March 28, 2015 An article in ... which could prove critical to organizations that deal with ... critical aspect of data security, is worsening . ... security report, every major category out of the twelve ... testing. “With all the craziness that has gone on ...
(Date:3/28/2015)... Pitching speed, player’s height, and pitching for multiple ... injuries, according to new research released today at the American ... , “Our findings indicate that a 10 inch increase in ... a history of injury, a 10 mile per hour increase ... a history of injury, and playing for more than one ...
(Date:3/28/2015)... How best to treat and recover ... orthopaedic medicine. While diagnostic hip injections are commonly performed ... etiology, research presented today at the American Orthopaedic Society ... that pain relief from this diagnostic injection may not ... “Our study looked to assess if the amount of ...
(Date:3/28/2015)... (PRWEB) March 28, 2015 Early surgery ... with Type V AC joint injuries, according to new ... today at the American Orthopaedic Society for Sports Medicine’s ... to duty faster when surgery was not performed. , ... 7 receiving surgical treatment and 17 receiving non-surgical therapy. ...
Breaking Medicine News(10 mins):Health News:Emergency Medical Care Celebrates Three Years of 24/7 Walk-In Urgent Care Services 2Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 2Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 3Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 4Health News:Researchers Highlight Shoulder and Elbow Injury Possibility in Youth Players 2Health News:Pain Injections for Hip Arthroscopy Patients May Not Predict Surgical Outcomes 2Health News:For Type V AC Joint Injuries, Early Surgery May Not Be the Best Approach 2
... have the largest volume of surgical procedures does not necessarily ... the results of a new study in the February issue ... . The findings of studies that suggest the higher ... hospital, the better that hospital,s outcomes will be, has resulted ...
... diseases like Alzheimer,s and Parkinson,s are partly attributable to ... Institutet in Sweden now demonstrate in a paper published ... enzymes can prevent the inflammation and thus constitute a ... microglial cells the nerve system,s primary immune cells ...
... By Randy Dotinga HealthDay Reporter , WEDNESDAY, March ... diabetes were able to get injections of a new insulin drug ... findings still need to be confirmed in another phase of research, ... it were approved for this use. But those caveats aside, ...
... colleagues at Case Western Reserve University School of Medicine have ... a universally fatal, degenerative brain disease for which there is ... and typically leads to death within a year of disease ... of PLoS ONE, a scientific journal produced by ...
... HealthDay Reporter , WEDNESDAY, March 9 (HealthDay News) ... kids, brains are developing an ability to help fight ... Over a three-year period, researchers from Oregon and California studied ... insight into the brain,s wiring during adolescence, finding the most ...
... WEDNESDAY, March 9 (HealthDay News) -- Stroke survivors recover ... involved in their exercise therapy, a new European study ... stroke survivors found that adding family-assisted exercise therapy to ... distance walked, and ability to perform activities of daily ...
Cached Medicine News:Health News:Referral to high-volume hospitals for operations fails to improve outcomes statewide 2Health News:New Drug May Trim Insulin Injections to Just 3 a Week 2Health News:Researchers identify new biomarker for Creutzfeldt-Jakob disease, the human form of mad cow disease 2Health News:Researchers identify new biomarker for Creutzfeldt-Jakob disease, the human form of mad cow disease 3Health News:As Peer Pressure Increases, So Does Brain's Ability to Resist It 2Health News:As Peer Pressure Increases, So Does Brain's Ability to Resist It 3Health News:Family Involvement Helps Stroke Patients With Rehab 2
The Acceava hCG Combo test provides superior performance for the diagnosis of pregnancy with a simple procedure that provides easy to read black on white results in 3 minutes for urine or 5 minutes f...
The Acceava pregnancy urine dipstick test provides qualitative determination of human chorionic gonadatropin in urine for early detection of pregnancy....
... Nucleic Sample Preparation Platform provides flexible, automated ... platform can prepare up to 96 patient ... and one half-hours, and performs onboard quantitation ... 30 minutes each. Based on Beckman ...
The Acceava Trichomonas Rapid Test is an immunochromatographic assay that detects pathogen antigens directly from vaginal swabs. Results are rapid, occurring within approximately 10 minutes....
Medicine Products: