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:7/30/2015)... N.J. , July 30, 2015  Unichem Pharmaceuticals ... recalling one lot of Hydrochlorothiazide tablets 25 mg 1000-count ... initiated as a precautionary measure due to the identification ... the product. The risk associated with ... tablet is the increased probability of experiencing Clopidogrel,s side ...
(Date:7/30/2015)... Tianyin Pharmaceutical Inc. (NYSE Amex: TPI ... the patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded ... the notice it received on May 21, 2015 from ... Company was below certain of the Exchange,s continued listing ... of the NYSE MKT Company Guide, due to the ...
(Date:7/30/2015)... YORK , July 30, 2015 /PRNewswire/ ... a new research report with market overview, ... share, forecast, porter analysis, recent developments, competitive ... Global Industry Insight: Biosensors Market Development ...      (Logo: http://photos.prnewswire.com/prnh/20150727/756778 ) ...
Breaking Medicine Technology:Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets 2TPI Provides Update Regarding Non-Compliance with NYSE MKT Continued Listing Requirements 2Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 2Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 3Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 4Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 5
... , Couple Wants to Promote Dialogue On Ethical Issues Raised by ... acknowledged inspiration for Jodi Picoult,s My Sister,s Keeper novel about a ... daughter with leukemia, is speaking out now ahead of the release ... , With the help of Denver infertility specialist Dr. William B. ...
... June 19 , , Dear Shareholder, , ... important developments taking place at this critical juncture in our company history. ... many as your president. , , Like many of you, ... I want you to know I am fully committed no matter how ...
Cached Medicine Technology:Inspiration for 'My Sister's Keeper' Speaks Out 2Alfacell Provides Shareholder Update 2Alfacell Provides Shareholder Update 3Alfacell Provides Shareholder Update 4Alfacell Provides Shareholder Update 5Alfacell Provides Shareholder Update 6
(Date:8/1/2015)... ... 01, 2015 , ... “ reTXT ” was featured on NewsWatch as part ... on the market for iOS, Android, and Windows. Joe Toohey, the host of AppWatch ... clarify, edit and delete any message including ones already sent. , While text messaging ...
(Date:7/31/2015)... (PRWEB) , ... August 01, 2015 , ... The Honor ... Global Advisory Panel on the Future of Nursing (GAPFON) 20-21 July 2015 in San ... to participate in this meeting. , Dr. Silvia Cassiani, Advisor, Nursing and Allied Health ...
(Date:7/31/2015)... ... July 31, 2015 , ... ... run by GoodThreads. The store can be accessed by visiting http://www.curemeso.org/store . ... which are customizable. The best part: whenever a product is purchased, the Meso ...
(Date:7/31/2015)... Rolling Meadows, IL (PRWEB) , ... July 31, ... ... great ways to communicate. Rally Insurance Group, Inc. has re-branded their social media ... provides a personal way for consumers to communicate, find information, share insights ...
(Date:7/31/2015)... Angeles, CA (PRWEB) , ... July 31, 2015 , ... ... surgeons and cosmetic experts gathered to see if they could reach a consensus on ... including breast augmentation and facelifts. Overall, the group reached 90 percent consensus on a ...
Breaking Medicine News(10 mins):Health News:Correct Auto-Correct and Clarify the Unclear with reTXT Messaging App 2Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 2Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 3Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 4Health News:Mesothelioma Organization Launches New Store 2Health News:Mesothelioma Organization Launches New Store 3Health News:Rally Insurance Group, Inc. Connects to Customers Through Re-branded Social Media Profiles 2Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 2Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 3
... fibrillation, other arrhythmias , MONDAY, Oct. 26 (HealthDay ... hard evidence that the characteristic snorting and gasping ... abnormalities. , Previous studies have suggested an association ... had not established a cause-and-effect relationship, said study ...
... Oct. 26 Burner Balm, a division of Pacific ... with Andre Ethier, right fielder for the NL West ... spokesperson for Burner Balm, an innovative lip balm developed ... and only dietary supplement to incorporate green tea extract, ...
... , Oct. 26 America,s Health Insurance Plans ... CEO: , "A new government-run plan would underpay doctors and hospitals ... quality. The American people want health care reform that will ... "The divisive debate about a government-run plan is a roadblock to ...
... Wis., Oct. 26 A free 40-minute webinar, ... Reform , is being sponsored by Compirion Healthcare ... Grove, Wisconsin. The webinar is premiering Wednesday, November 18th ... at http://www.compirion.com/webinars/seminar_healthcare_reform.cfm . This important webinar ...
... in women, wide waists in men spell trouble, study finds ... excess body fat appears to affect the risk of dangerous ... and women, a new Danish study indicates. , The 10-year ... risk of venous thromboembolism (VTE) in women but not men, ...
... researchers have found that a sometimes deadly stomach bug, ... in outpatient settings. Clostridium difficile is a ... to life-threatening inflammation of the colon. These findings were ... (ACG) Annual Meeting in San Diego. Clostridium ...
Cached Medicine News:Health News:Sleep Apnea Episodes May Trigger Irregular Heartbeat 2Health News:Burner Balm Lip Balm Hits Home Run With L.A. Dodger Andre Ethier 2Health News:AHIP Statement on Government-Run Plan 2Health News:AHIP Statement on Government-Run Plan 3Health News:Free Webinar for CEOs on Preparing Your Hospital for Healthcare Reform 2Health News:Free Webinar for CEOs on Preparing Your Hospital for Healthcare Reform 3Health News:Where You Put on Pounds May Influence Clot Risk 2Health News:Deadly stomach infection rising in community settings, Mayo Clinic study finds 2
...
Knot tier...
... Blitz Suture Retriever is for arthroscopic and open ... design eliminates complicated procedural steps. It may ... suture material and in conjunction with,anchors or screws ... small, curved needle tip permits the placement of ...
... RC Retractor comes with several ... superficial or deep muscle retraction. ... retraction in three different directions: ... The fiber optic light cable ...
Medicine Products: