Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Life Technologies Screening Technology Receives Emergency Use Authorization

Published: Wednesday, June 26, 2013
Last Updated: Wednesday, June 26, 2013
Bookmark and Share
Life Technologies supports global effort to help accelerate emergency screening of Novel Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

Life Technologies Corporation announces that its Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument is suitable for use with the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay, which has received Emergency Use Authorization for detection in patient specimens of the novel Middle East Respiratory Syndrome Coronavirus (MERS-CoV). To date the virus has been found in Jordan, Qatar, Saudi Arabia, the United Arab Emirates (UAE), France, Germany, Italy, Tunisia and the United Kingdom. Globally, since September 2012, the World Health Organization (WHO) has been informed of a total of 64 laboratory-confirmed cases of the infection with MERS-CoV, including 38 deaths.

Additionally, the CDC Novel Coronavirus 2012 Assay can be performed using Life's SuperScript III One-Step qRT-PCR reagent kit. The Respiratory Syndrome Coronavirus (MERS-CoV) Assay is intended to quickly monitor the spread of the pathogen and thwart a potential pandemic. To support this global need, Life Technologies is increasing production of its reagents and shipping them to labs around the world. This test has been authorized only for the diagnosis of Respiratory Syndrome Coronavirus (MERS-CoV) and not for the diagnosis of any other viruses or pathogens.

"We are working continually with our partners to improve capabilities, particularly tests that work more quickly and simply on more people," said Mark Stevenson, president and chief operating officer at Life Technologies. "Our technology aids public health labs around the globe to identify threats and develop rapid detection kits."

The test has been authorized by FDA under an Emergency Use Authorization for use by qualified laboratories. The CDC Novel Coronavirus 2012 Assay has not been FDA cleared or approved.

The CDC Novel Coronavirus 2012 Assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of MERS-CoV under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C section 360bbb-3(b)(1).

Last year, Life Technologies established the Global Influenza Network, a partnership of scientists at a number of the world's leading government public health organizations, veterinary agencies and research institutes who collaborate in an effort to increase the speed and efficiency of influenza monitoring and vaccine development. This network builds upon Life Technologies' strong history of working with the CDC, the WHO and public health labs to combat virus outbreaks:

•    Last month, the company's 7500 Fast Dx Real-Time PCR instrument was indicated as the sole instrument for use with the CDC's influenza A (H7/N9) virus, which received emergency use authorization for detection in patient specimens of the novel influenza A (H7/N9) virus.
•    In 2011, the company developed a custom assay to accurately detect the E. coli bacterium that spread through Europe. The assay was developed after company researchers, using samples supplied by scientists at University Hospital Munster, completed the DNA sequencing and analysis work on the deadly E. coli strain using the Ion PGM™ Sequencer.
•    In 2009, Life Technologies formed a special 24-hour-a-day task force to respond to global requests for assistance with the H1N1 outbreak.

The SuperScript III One-Step qRT-PCR kit is for research use only; not for use in diagnostic procedures.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More Than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

FBI Approves Life Technologies' Forensics Kit
Ability to upload forensic samples to National DNA Index System using GlobalFiler DNA chemistry enables faster, more powerful data comparisons to solve crimes in the U.S. and globally.
Tuesday, June 24, 2014
Distribution Agreement to Offer GlobalFiler Express Chemistry
Life Technologies today announced it has signed an agreement giving IntegenX Inc. the rights to distribute its GlobalFiler Express chemistry on IntegenX’s RapidHIT™ platform.
Wednesday, February 26, 2014
Life Technologies' Ion AmpliSeq™ Exome Program Adds 12 New Members
With more than 30 members the program is the largest network of next generation-based exome sequencing providers in the world.
Friday, December 20, 2013
Life Tech's Food Pathogen Detection Methods Approved by Australian Government
MicroSEQ Real-Time PCR workflows approved as method for testing Australian export meat and meat products.
Tuesday, December 17, 2013
KACST Partners with Life Tech in The Saudi Human Genome Program
Program aims to analyze 100,000 human genomes to identify the causes of disease in the population of the Kingdom of Saudi Arabia and the Arab world.
Monday, December 09, 2013
Life Technologies Awards Digital PCR Innovation Grants to Five Research Labs
The five Innovation Grant recipients in the Digital PCR Applications Grant Program was announced during the ASHG conference in Boston.
Thursday, October 24, 2013
BGI Partners with Life Technologies
World's largest genome center to purchase 50 Ion Proton™ Sequencers from Life Technologies.
Tuesday, October 22, 2013
Life Technologies Extends Partnership with DNAVEC
R&D collaborative agreement aims to further develop Sendai virus-based tools for basic and translational research.
Monday, October 21, 2013
Life Tech's Forensic Kit Approved by FBI
Life Technologies GlobalFiler™ Express Kit has been approved by the FBI for use by laboratories generating DNA profiles for inclusion in the National DNA Index System CODIS Database.
Friday, October 11, 2013
Life Technologies Expand Ion AmpliSeq™ Exome Certified Service Provider Program
Due to increased demand the program is expanding to include eleven new members.
Wednesday, October 09, 2013
TriCore Reference Laboratories Named First NGS Center of Excellence by Life Technologies
Collaborative partnership designed to accelerate clinical research in the Southwest using advanced NGS oncology panels.
Thursday, September 19, 2013
Thermo Acquisition Approved by Life Technologies Stockholders
Company announced that its stockholders voted to adopt the previously announced merger agreement.
Thursday, August 22, 2013
Life Technologies Enters into an Exclusive License and Supply Agreement for Dynabead
Life Technologies has signed a long-term supply and exclusive licensing agreement with Novartis for immunotherapeutics involving T cells modified to express chimeric antigen receptors for the treatment of cancer.
Thursday, August 01, 2013
Life Technologies Announces Second Quarter 2013 Results
Revenue increased 1% excluding impact of currency.
Thursday, August 01, 2013
Life Technologies Opens State-of-the-Art DNA Forensics Laboratory in India
The new Life Forensics Laboratory will provide much needed high-throughput DNA profiling services in India to help accelerate the sampling process, while saving time and money.
Thursday, August 01, 2013
Scientific News
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Lab-on-a-Chip Offers Promise for TB and Asthma Patients
A device to mix liquids using ultrasonics is the first and most difficult component in a miniaturized system for low-cost analysis of sputum from patients with pulmonary diseases such as tuberculosis and asthma.
Intracellular Microlasers Could Allow Precise Labeling of up to a Trillion Individual Cells
MGH investigators have induced structures incorporated within individual cells to produce laser light at wavelengths that differ based on the size, shape and composition of each microlaser, allowing precise labeling of individual cells.
Real-Time Imaging of Lung Lesions During Surgery
Targeted molecular agents cause lung adenocarcinomas to fluoresce during surgery, according to pilot report.
Watching a Tumour Grow in Real-Time
Researchers from the University of Freiburg have gained new insight into the phases of breast cancer growth.
Protein Related to Long Term Traumatic Brain Injury Complications Discovered
NIH-study shows protein found at higher levels in military members who have suffered multiple TBIs.
Childhood Cancer Cells Drain Immune System’s Batteries
Cancer cells in neuroblastoma contain a molecule that breaks down a key energy source for the body’s immune cells, leaving them too physically drained to fight the disease.
Urine Proteins Point to Early-Stage Pancreatic Cancer
A combination of three proteins found at high levels in urine can accurately detect early-stage pancreatic cancer, researchers at the BCI have shown.
Researcher Discovers Trigger of Deadly Melanoma
New research sheds light on the precise trigger that causes melanoma cancer cells to transform from non-invasive cells to invasive killer agents, pinpointing the precise place in the process where "traveling" cancer turns lethal.
New Vaccine For Chlamydia to Use Synthetic Biology
Prokarium Ltd, a biotechnology company developing transformational oral vaccines, have announced new funding from SynbiCITE, the UK’s Innovation and Knowledge Centre for Synthetic Biology.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!