Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
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 3,300+ scientific posters on ePosters
  • More than 4,800+ 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

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 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 KDR Biotech
The acquisition is part of Life Technologies strategic international growth plan in fast-growing markets.
Friday, April 12, 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 Announces Fourth Quarter and Fiscal 2012 Results
Fourth quarter revenue increased 3% to $999 million, or 4.5% excluding currency.
Tuesday, February 12, 2013
Life Technologies Receives FDA 510(k) Clearance for Diagnostic Use of Products
Life's Applied Biosystems Dx Genetic Analyzer and SeCore® kits constitute first sequence-based system cleared for HLA typing.
Tuesday, February 12, 2013
JAMA Study Demonstrates Efficacy of Life Technologies' Lung Cancer Test
Genetic test identifies patients at high risk for mortality in the earliest stage of lung cancer. Study suggests test could maximize the benefits of early screening if used in combination with computed tomography.
Thursday, November 08, 2012
Life Technologies Announces Third Quarter 2012 Results
Revenue for the third quarter was $911 million, a decrease of 1.9 percent over the $929 million reported for the third quarter of 2011. Excluding the impact of currency, revenue growth for the quarter was 1.4 percent compared to the same period of the prior year.
Monday, November 05, 2012
VelaDx Signs Agreement with Life Technologies to Develop IVD Tests on Ion PGM Sequencer
Semiconductor sequencing brings unprecedented power to diagnostic tests to transform personalized medicine.
Wednesday, October 10, 2012
Life Technologies Acquires Compendia Bioscience
Bioinformatics expertise will enable deeper engagement with established customer base of leading pharmaceutical companies.
Tuesday, October 09, 2012
Life Technologies and SATuRN Collaborate to Increase Access to HIV Testing
Life and Southern African Treatment and Resistance Network (SATuRN) partner in sequencing-based surveillance of drug resistance,in order to increases access in Africa.
Tuesday, July 24, 2012
Acquisition of Navigenics Expands Life Technologies' Capabilities
Addition of Navigenics' physician portal provides informatics to support patient management.
Thursday, July 19, 2012
Acquisition of Navigenics Expands Life Technologies' Capabilities in Diagnostics
CLIA-certified laboratory enables life technologies to launch lab-developed tests and expand partnership program in companion diagnostics.
Wednesday, July 18, 2012
Life Technologies to Accelerate Development of Ion Torrent Semiconductor Technology
Company to accelerate technology for a broad set of proteomic and antibody-based applications after passing internal Life Technologies R&D milestones.
Thursday, July 12, 2012
Scientific News
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
Review of the Analysis of Haemoglobin A1c for Diabetes Diagnostics
This paper aims to clarify methods, units, quality requirements, reference and cutoff limits for hemoglobin A1c (HbA1c) and ratio of blood glucose/HbA1c on the basis of the results from Finnish quality control surveys by comparing them to the literature.
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Drug - Gene 'One-Two' Punch Against Cancer
Researchers identify gene-drug combinations that, together, target and kill cancer cells while not targeting healthy cells.
Liquid Biopsies Treating Ovarian Cancer
Researchers have discovered a promising monitor and treat recurrence of ovarian cancer. Detecting cancer long before tumours reappear.
72% Rise in Metastatic Prostate Cancer
Over the 2003-2013 period metastatic cancer has increased by an average of 72%, this could be caused by lax screening, more aggressive disease or both.
Lab-Tested Diagnosis Needed When Treating Persistent Diarrhea
New PCR multiplex method makes lab testing more effective.
Biomarker for Multiple Sclerosis Detection Discovered
Winthrop-University Hospital researchers discover biomarker for multiple sclerosis detection.
Scientists Link Bipolar Disorder to Unexpected Brain Region
Researchers from The Scripps Research Institute have found that gene within the brain’s striatum could be linked to biopolar disorder.
Liquid Biopsies: DNA Size Matters
Study finds circulating tumour DNA can be distinguished from healthy DNA through fragment size identification.
SELECTBIO

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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!