Navigation Links
FDA Clears the Quest Diagnostics Simplexa® C. difficile Molecular Test
Date:4/11/2012

MADISON, N.J. and CYPRESS, Calif., April 11, 2012 /PRNewswire/ -- Quest Diagnostics  (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its Simplexa C. difficile Universal Direct Test on the 3M™ Integrated Cycler. 

The test, from the company's Focus Diagnostics business, is intended to aid in the diagnosis of Clostridium difficile-associated disease, one of the most common and dangerous acquired infections in healthcare settings. It uses a proprietary technique to eliminate the time consuming nucleic-acid sample extraction process required by many other molecular tests, for potentially faster results reporting for hospitals and clinical laboratories.

Simplexa tests, running on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively detect viruses, bacteria and other analytes. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C. difficile, including NAP1. The test uses a proprietary chemistry that eliminates the need for nucleic-acid extraction. Using the Simplexa test, hospital and other labs may complete the entire testing process in about an hour.

C. difficile-associated disease is a common and sometimes fatal healthcare-associated infection that causes diarrhea and other intestinal problems. As many as 14,000 people die of C. difficile-associated disease in the United States each year, according to the U.S. Centers for Disease Control and Prevention. 

"Detecting and containing C. difficile associated disease is one of the greatest clinical challenges in today's healthcare environment," said Jay M. Lieberman, M.D., medical director, infectious disease, for Quest Diagnostics and Focus Diagnostics.  "Fast, reliable PCR tests that are highly specific and sensitive in the detection of the tcdB gene, a toxin-B producing gene of C. difficile, are essential for identifying and treating this infection as well as containing its spread."

With the FDA clearance, the Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler is immediately available in the United States. Focus Diagnostics launched the test in Europe during the second quarter of 2011.

About Simplexa®

Focus Diagnostics, a wholly-owned business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M™ Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M™.  Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional FDA-cleared Simplexa tests aid the detection of influenza A and B and respiratory syncytial virus. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr and BK viruses, are CE marked and distributed in Europe. In 2011, the Simplexa/3M technology won a gold Medical Design Excellence Award in the in vitro diagnostics category and an Edison Award for new science and medical diagnostic product.

To learn more about or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe), or visit SimplexaDx.com or FocusDx.com.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

Quest, Quest Diagnostics, Simplexa and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics.

Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900


'/>"/>
SOURCE Quest Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
9. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
10. FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
11. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/20/2017)... Provides understanding and access to the ... the worlds leading healthcare companies. Download the ... Global Anemia Partnering Terms and Agreements since 2010 ... and agreements entered into by the world,s leading ... deals - Top deals by value ...
(Date:2/20/2017)... -- This Report analyzes the worldwide markets for Pharmaceutical Contract Manufacturing in ... and Liquid & Semi-solid Dosage Forms. The report provides separate comprehensive ... Japan , Europe , Asia-Pacific ... full report: http://www.reportlinker.com/p04707109-summary/view-report.html ... Annual estimates and forecasts are provided for the ...
(Date:2/20/2017)... Feb. 20, 2017 This report analyzes the worldwide ... market is analyzed by the following Segments: Biologic Meshes, and ... US, Canada , Japan ... , and Rest of World. Read the ... forecasts are provided for the period 2015 through 2022. Also, ...
Breaking Medicine Technology:
(Date:2/21/2017)... , ... February 21, 2017 , ... ... Nation Regional Medical Clinic in Durant, Oklahoma, on Feb. 21. , The celebration ... tours for community members, clinic employees, the construction team and tribal leadership. ...
(Date:2/21/2017)... ... 21, 2017 , ... Doctors on Liens has announced the addition of ... , to its growing network of doctors in Central and Northern California. Dr. Mendonca ... such as whiplash, back pain, neck pain, hip and knee pain, and headaches. ...
(Date:2/21/2017)... ... February 21, 2017 , ... Ray Insurance Agencies, a Dallas area firm ... County, is embarking on a six month charity event aimed at raising local support ... Cancer is one of the deadliest diseases in America; more than 7.5 million people ...
(Date:2/21/2017)... (PRWEB) , ... February 21, ... ... of technology-enabled clinical trial solutions, today announced the further expansion of its ... applications they can leverage as part of Bioclinica’s extensive and growing eHealth ...
(Date:2/21/2017)... ... February 21, 2017 , ... HIMSS is the largest ... demonstration spanned multiple health information systems including OpenEMR, EMRDirect, and Epic. , ... no Health Information Exchange outside of faxing. Medal’s innovative technology “meets providers where ...
Breaking Medicine News(10 mins):