Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

New Immunoassay for Detection of Buprenorphine and Three Major Metabolites

Thermo Fisher Scientific
Posted on: 31 Jul 17

SAN DIEGO, July 31, 2017 /PRNewswire/ -- AACC -- A new immunoassay for the specific detection of buprenorphine and its three major metabolites -- buprenorphine-β-D-glucuronide, norbuprenorphine, and norbuprenorphine-β-D-glucuronide  -- has received 510(k) clearance from the U.S. Food and Drug Administration, registration in Canada, Australia, and New Zealand, as well as CE Mark and registration in various countries in the European Union. 

The product will be on exhibit in booth #4039 during the 2017 American Association of Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo, being held July 31 – August 3 at the San Diego Convention Center.

Buprenorphine is considered a more practical, and in some cases, a more effective alternative to methadone in the treatment of opioid addiction because it can be prescribed on an outpatient basis rather than in methadone clinics. In addition, because buprenorphine only partially activates the opioid receptors, it produces a milder effect than other opiates.  The CEDIA Buprenorphine II Assay also has no significant cross-reactivity to other opioids, such as morphine, making it suitable for testing the urine samples from patients on Slow-Release Oral Morphine (SROM) therapy (trade name Substitol®). The assay can accurately differentiate Buprenorphine treatment samples from SROM treatment samples.

"The CEDIA Buprenorphine II Assay is the only assay on the market that detects all three major metabolites," said John Kody, vice president and general manager, clinical diagnostics, at Thermo Fisher Scientific.  "The ability to detect each of these metabolites is important because it minimizes the potential for false-negative results."

The CEDIA Buprenorphine II Assay is a no-wash (homogeneous) immunoassay that specifically detects buprenorphine and its three major metabolites, demonstrates good correlation with LC-MS/MS and has excellent specificity and sensitivity, making it an easy-to-use screening tool. The assay utilizes proprietary CEDIA technology, including a lyophilized formulation that is easily reconstituted and can run in both qualitative and semi-quantitative modes.  Calibrators and controls are sold separately, and applications are available for a variety of clinical chemistry analyzers.

All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. CEDIA is a trademark of Roche Diagnostics and Substitol is a trademark of Mundipharma AG.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

Media Contact Information:
Adrielle Henry
Phone: 1+ 510-979-5000 ext.1653507
E-mail: Adrielle.Henry@thermofisher.com        
Website: www.thermofisher.com/BUPtwo

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 31/07/2017

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.