Corporate Banner
Satellite Banner
qPCR
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Life Technologies Launches CE-IVD Marked QuantStudio™ Dx Real-Time PCR Instrument in Europe

Published: Monday, November 19, 2012
Last Updated: Monday, November 19, 2012
Bookmark and Share
Flagship qPCR instrument offers reliability, accuracy, ease of use and flexibility for IVD and lab-developed diagnostic tests.

Life Technologies Corporation today announced the launch of its Applied Biosystems QuantStudio™ Dx Real-Time PCR Instrument designed to meet the specific needs of clinical diagnostic laboratories. The instrument is CE-IVD marked for use in Europe and represents a significant extension of Life Technologies' product offerings in the diagnostics arena.

"Molecular diagnostic tests based on real-time PCR have become indispensable to the clinical lab," said Ronnie Andrews, president of Medical Sciences at Life Technologies. "Molecular testing is the fastest-growing segment of the diagnostics market, and the QuantStudio™ Dx instrument has unique features that will allow us to capture that market growth."

The global IVD (in vitro diagnostic) market is approximately $52 billion and is expected to reach $70 billion by 2015. The current European IVD market is approximately $14 billion and expected to reach $17 billion by 2015.

The QuantStudio™ Dx Real-Time PCR Instrument can perform numerous diagnostic functions, including pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection, micro-RNA and other non-coding RNA analysis, and high-resolution melt analysis.

The instrument's touchscreen, reagent and sample tracking, and LIMS (Laboratory Information Management Systems) interface are specifically designed for ease of use. Flexibility is enabled through easily interchangeable thermal cycling blocks that accommodate 96- or 384-well plates and a proprietary qPCR microfluidics card, which can perform 48 tests on eight samples simultaneously without the need for liquid-handling robots. The card can also be used to design and implement custom tests. Life Technologies is currently developing diagnostic tests utilizing this format.

Two software options are available on the instrument. The QuantStudio™ Dx Software runs IVD (in vitro diagnostic) tests in a secure mode with pre-set run and analysis parameters, while the QuantStudio™ Test Development Software enables development of custom tests and supports clinical research projects.

"We recognize that clinical laboratories have multiple needs," said Andrews. "Accuracy and reliability are paramount when running diagnostic tests for physician reporting. In addition medical research labs need instrumentation that supports experimental work. The QuantStudio™ Dx instrument addresses both these needs."

The instrument is being released with CE-marked Quidel® Molecular Assay for C. difficile for detection of hospital-acquired infections, which Life Technologies distributes. Additional Quidel Molecular infectious disease applications are currently under development and will be available in 2013, including an influenza A + B Assay, a human metapneuomvirus (hMPV) + respiratory syncytial virus (RSV) Assay, and a herpes simplex virus 1 and 2, and varicella zoster virus (chicken pox and shingles) Assay.

Life Technologies plans to submit the QuantStudio™ Dx Real-Time PCR Instrument for 510(k) clearance to the United States Federal Food and Drug Administration (FDA) in December 2012.

The QuantStudio™ Dx Real-Time PCR Instrument is among a growing line of Life Technologies platforms for diagnostic use. The Applied Biosystems 3500 Dx Genetic Analyzer, a Sanger sequencing instrument, is currently CE-IVD marked. The company also offers the AcroMetrix® line of quality controls for molecular diagnostic assays.

"The Life Technologies Applied Biosystems brand has a 30-year heritage of leadership in the PCR market," said Andrews. "We also have a broad partnership base in the diagnostic and pharmaceutical space that will support content development across our Sanger and next generation sequencing instruments - platforms that we expect will play an increasingly important role in the clinic. In short, Life Technologies has the capability and the commitment to fully equip the diagnostic lab of the future."


Further Information

Join For Free

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 4,000+ scientific posters on ePosters
  • More than 5,300+ 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
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
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
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 Announces Second Quarter 2013 Results
Revenue increased 1% excluding impact of currency.
Thursday, August 01, 2013
Life Technologies Signs Five-Year Agreement with the FDA
The agreement aims to accelerate and advance food safety testing of E. coli and Salmonella, two foodborne contaminants commonly associated with outbreaks and/or recalls.
Tuesday, July 30, 2013
Life Technologies Expands CEERAM Food Safety Range to Global Market
Award-winning products broaden industry-leading portfolio of food safety solutions.
Friday, July 26, 2013
Life Technologies Expands Line of qPCR Instruments
Company simultaneously introduces two flexible systems in the QuantStudio™ product line designed to meet varying throughput and budget needs of customers.
Thursday, July 25, 2013
Life Technologies to Collaborate with Merck Serono
Long-term collaboration is aimed at developing, obtaining regulatory approval and commercializing companion diagnostics for selected Merck Serono drug development programs.
Wednesday, July 17, 2013
Life Technologies Screening Technology Receives Emergency Use Authorization
Life Technologies supports global effort to help accelerate emergency screening of Novel Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Wednesday, June 26, 2013
Life Technologies Acquires Life Science Korea
The acquisition strengthens Life Tech's go-direct strategy in South Korea.
Friday, June 14, 2013
Life Technologies Begins Shipping QuantStudio™ 3D Digital PCR System
Disruptive benchtop system makes digital PCR attainable to any lab.
Tuesday, June 11, 2013
Life Technologies Supports Emergency Screening of Avian Influenza (H7N9) Virus
Company's instruments FDA-cleared under Emergency Use Authorization declaration.
Monday, April 29, 2013
Life Technologies to Invest $18 Million in Facility Expansion and Current GMP Compliance Plan
Project aims to broaden product offerings to growing diagnostics and pharmaceutical customer base.
Tuesday, April 02, 2013
Life Technologies Signs Stem Cell Agreement with Harvard University
Research collaboration aimed at yielding standardized method for evaluating iPS cell quality; deepens Life's investment to its expanding stem cell product portfolio.
Tuesday, March 05, 2013
Scientific News
Top 10 Life Science Innovations of 2016
2016 has seen the release of some truly innovative products. To help you digest these developments, The Scientist have listed their top picks for the year.
Using Cancer Cells' Mass to Predict Treatment Response
A device has been developed that can detect changes in cell mass at a minute scale.
NVIDIA Awards $400k to Trailblazers in Cancer Research
NVIDIA Foundation furthers research that could lead to new and more targeted treatments with investments.
Malaria Parasite Evades Rapid Test Detection in Children
A study at the University of North Carolina found that gene deletion poses a threat to Malaria eradication efforts.
Working With Advanced Nanoimagers
Oxford Nanoimaging report on the work of early-adopters for their Nanoimager technology at the MRC Centre for Molecular Bacteriology and Infection.
History of Cells Told Through MEMOIR
MEMOIR technique developed by CalTech researchers enables the life history of cells to be read.
Nanoscale ‘Muscles’ Powered by DNA
Scientists have developed nanoscale "muscles" to integrate with custom DNA, that can force the material to bend, curl and flip.
Dissecting Bacterial Infections at the Single-Cell Level
Researchers have used single-cell analysis technology to provide new insight into the Salmonella infection process.
Peer Review is in Crisis, But Should be Fixed, Not Abolished
After the time to get the science done, peer review has become the slowest step in the process of sharing studies, and some scientists have had enough.
Cancer Stem Cells Fuel Tumor Growth
Mass. General, Broad Institute team finds strong evidence that cancer stem cells are important drivers of tumors in patients.
Skyscraper Banner

SELECTBIO Market Reports
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
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!