Navigation Links
Fujirebio Diagnostics, Inc. Receives FDA 510 (k) Clearance for First Biomarker to Monitor Lung Cancer
Date:5/31/2011

MALVERN, Pa., May 31, 2011 /PRNewswire/ -- Fujirebio Diagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance to the CYFRA 21-1™ EIA assay to monitor disease progression during the course of disease and treatment of lung cancer patients. This is the first biomarker assay kit to be cleared by FDA for use in the management of patients with lung cancer.

"The clearance of the CYFRA 21-1 assay kit adds to Fujirebio's growing portfolio of tumor marker assays for ovarian cancer, pancreatic cancer, breast cancer, and other malignancies," commented Monte Wiltse, Vice President of Sales and Marketing at Fujirebio Diagnostics. "Achieving FDA clearance of the CYFRA 21-1 assay kit for lung cancer is the first step in what we anticipate will be a strong pipeline of innovations that help physicians in the management of lung cancer."

The CYFRA 21-1 assay kit is indicated for the quantitative determination of soluble cytokeratin 19 fragments in human serum. It is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with lung cancer. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer. Data submitted to FDA showed that changes in CYFRA 21-1 values correlated with changes in disease status in 76% of the studied patient population.

According to the Surveillance Epidemiology and End Results (SEER) database of the National Cancer Institute (NCI), an estimated 222,520 new cases of lung cancer were diagnosed in the U.S. in 2010, and roughly 157,300 Americans died of the disease.(1)

"FDA clearance of CYFRA 21-1 allows laboratories in the US the opportunity to provide a valuable diagnostic tool to oncologists in the management of lung cancer," said David Grenache, PhD, a Medical Director at ARUP Laboratories in Salt Lake City, UT. "ARUP Laboratories
'/>"/>

SOURCE Fujirebio Diagnostics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Fujirebio Diagnostics Named Life Sciences Company of the Year
2. Siemens Showcases New Innovations in Clinical Diagnostics, Automation, and IT at IFCC-WorldLab Berlin 2011
3. Ridge Diagnostics, Inc. CEO to Speak at Neurotech Investing and Partnering Conference
4. OnPoint Medical Diagnostics, Inc. and Vertical Health Solutions, Inc. Complete Reverse Merger
5. Reportlinker Adds Merger and Acquisition Terms and Agreements in Pharma, Biotech and Diagnostics, 4th edition
6. Reportlinker Adds Co-promotion and Co-marketing Agreements in Pharma, Biotech and Diagnostics, 4th Edition
7. AMDL Diagnostics, Inc. Enters Into Exclusive Distribution Agreement With Grifols USA, LLC to Advance Commercialization of DR-70 Onko-Sure(TM) Cancer Test
8. Ridge Diagnostics, Inc. Clinical Data on Blood Test for Depression Presented at American Psychiatric Association Annual Meeting
9. Ridge Diagnostics, Inc. Awarded Phase 2 National Science Foundation Grant
10. Vermillion Renews Strategic Alliance Agreement With Quest Diagnostics, Inc.
11. Pressure BioSciences, Inc. Announces $850,000 NIH SBIR Phase II Award for the Development of a New PCT-dependent System for Improved Biomarker Discovery, Diagnostics, and Drug Discovery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/30/2014)... 2014   Royal Philips  (NYSE: PHG, AEX: PHIA) ... new ultrasound system designed to enable global hospitals and ... volumes and cost pressures. Making its debut at the  ... Barcelona this week, Affiniti provides innovative ... fewer resources deliver high quality patient care. ...
(Date:8/29/2014)... CHAPEL HILL, N.C. , Aug. 29, 2014 /PRNewswire/ ... Opinion Leaders (KOLs) can be the difference between a ... struggle to effectively map and stratify KOL targets – ... to build the type of strong relationships upon which ... recent research, savvy pharma companies have identified internal inconsistencies ...
(Date:8/29/2014)... YORK , Aug. 29, 2014 Pomerantz ... TMS S.A. ("EDAP" or the "Company") (NASDAQ: EDAP ... filed in United States District Court, Southern District of ... 14-cv-6069, is on behalf of a class consisting of ... February 1, 2013 and July 30, 2014, inclusive (the ...
Breaking Medicine Technology:Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 2Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 3Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 4Implementing a Strategic Thought Leader Management & Engagement System 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 3
... Addex Pharmaceuticals,announced today the successful completion of ... its lead compound ADX10059 in patients with,gastro-esophageal ... a significant unmet medical need. The study ... esophageal pH, with,statistical significance, and also showed ...
... in Blood Highlight Millennium Leadership in,Personalized Medicine and ... Therapy in Broad Range of Multiple Myeloma Patients ... published in the April 15th issue of Blood ... Pharmaceuticals, Inc. has,discovered biomarkers which may lead to ...
Cached Medicine Technology:Addex Achieves Statistically Significant Outcome in Phase IIa,Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease 2Addex Achieves Statistically Significant Outcome in Phase IIa,Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease 3Addex Achieves Statistically Significant Outcome in Phase IIa,Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease 4Addex Achieves Statistically Significant Outcome in Phase IIa,Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease 5Millennium Discovers Biomarkers Potentially Predictive of Response,to Velcade (Bortezomib) for Injection 2Millennium Discovers Biomarkers Potentially Predictive of Response,to Velcade (Bortezomib) for Injection 3Millennium Discovers Biomarkers Potentially Predictive of Response,to Velcade (Bortezomib) for Injection 4Millennium Discovers Biomarkers Potentially Predictive of Response,to Velcade (Bortezomib) for Injection 5Millennium Discovers Biomarkers Potentially Predictive of Response,to Velcade (Bortezomib) for Injection 6
(Date:8/30/2014)... Serving contented clients since inception, #1 ... Outsourcing is now offering discount for Labor Day ... emphasize on putting forward the best of web development ... dedicated team of professionals and web developers and designers ... even the critical issues of web development and can ...
(Date:8/30/2014)... PA (PRWEB) August 30, 2014 "I had ... because of her crutches," said an inventor from Wetumpka, Ala. ... sights and sounds of the shore, I came up with ... sand." , She created a prototype for the patent-pending Deezers ... accessory enables the individual to use crutches, walkers, or canes ...
(Date:8/30/2014)... In today’s world, a good night’s ... get. Snoring and sleep apnea (a medical problem where ... people and their bed partners of the rest they ... of the population snores and 20 million people in ... only 10% have been diagnosed and treated; and of ...
(Date:8/30/2014)... The new review published by Daily Gossip reveals ... Brimeyer, who wanted to make her guide accessible to sufferers ... now easy to find in the form of an eBook, ... author of the new method shares all her tips and ... in its review that the leaky gut syndrome can be ...
(Date:8/30/2014)... LiveStreamingFitness.com, a company dedicated to providing live ... resources, is proud to announce it has been recognized as ... fitness solutions by ABC’s Good Morning America. ... Good Morning America, “Live Streaming Fitness is the hottest new ... by streamlining your workout…to boot camp at Life Streaming Fitness ...
Breaking Medicine News(10 mins):Health News:Profit By Outsourcing Offering Discount for Labor Day on all Web Development Services 2Health News:Snoring: Bad for Relationships, Bad for Health 2Health News:Snoring: Bad for Relationships, Bad for Health 3Health News:Leaky Gut Cure Review Reveals Unique Method to Stop Chronic Symptoms 2Health News:LiveStreamingFitness.com is New Trend In Fitness 2
... spent socializing raised peoples, test scores, researchers say , ... gab could boost brainpower, new research suggests. , A ... 10 minutes a day improves memory and test scores. ... as more traditional kinds of mental exercise in boosting ...
... toddler years, study finds , FRIDAY, Nov. 16 (HealthDay News) ... how a child,s nervous system will develop through its toddler ... National Institutes of Health researchers checked fetal heart rate and ... decreases within a specific time period -- six times from ...
... Speaker Nancy Pelosi,will join Congressmen Ciro D. ... to discuss the State Children,s Health,Insurance Program (SCHIP) ... children., WHO: Speaker Nancy Pelosi Congressman ... (TX-20) Congressman Henry Cuellar (TX-28), WHAT: ...
... America,s Seniors, WASHINGTON, Nov. 16 A ... (OIG) finding that in Medicare Part D,generic drugs ... generic,substitutes were available and that 56 percent of ... benefit manager (PBM) tools are,driving down prescription drug ...
... Cancer Early Detection and,Treatment Research Trust Fund, WASHINGTON, ... Susan Fargo, the Senate Chair of the Joint,Committee on ... for lung cancer research., "This is a watershed ... those at risk for the disease in Massachusetts," said ...
... WASHINGTON, Nov. 16 House Republican Whip,Roy Blunt ... alleged "compromise" offer to reduce their spending demands ... Democrats offered to ,compromise, and reduce their demand,for ... billion.,Interestingly, this offer did not include anything about ...
Cached Medicine News:Health News:Talking With Others May Make You Smarter 2Health News:Fetal Heart Rate Points to Later Child Development 2Health News:New OIG Report Confirms Part D Plans Are Driving Generic Utilization 2Health News:Lung Cancer Alliance Hails Massachusetts Senator for Taking Lead on Lung Cancer Legislation 2
This fixed-volume digital micropipet is used to accurately measure and transfer 5 microliters of solution....
... A fixed pipette is ideal ... single volume. Fixed volume FInnpipettes ... advantages as other Finnpipette Digital ... Super blow-out (1-40ul), Soft-touch tip ...
10L...
... ergonomics, and value!, Comfortable feel ... non-slip, contoured handle , Finer control ... spring action , Completely autoclavable for ... need for recalibration , Easy-to-read precision ...
Medicine Products: