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

Life Technologies Receives FDA 510(k) Clearance for Diagnostic Use of Products

Published: Tuesday, February 12, 2013
Last Updated: Tuesday, February 12, 2013
Bookmark and Share
Life's Applied Biosystems Dx Genetic Analyzer and SeCore® kits constitute first sequence-based system cleared for HLA typing.

Life Technologies Corporation announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore® HLA typing kits. The development represents additional execution against the company's strategy to become a leader in the diagnostics market by offering both novel clinical assays and best- in-class molecular testing products.

"This successful application for our Sanger sequencer with HLA typing kits is further demonstration of Life Technologies' track record in obtaining FDA regulatory clearance for genetic analysis in the clinical market," said Greg Lucier, chairman and chief executive officer of Life Technologies.  "We will continue to aggressively pursue a regulatory pathway for our leading technologies in the clinical space, including next-generation sequencing."

The company's 7500 Fast Dx Real-time PCR system was cleared for diagnostic use with the Center for Disease Control's H1N1 assay in 2008.  Life Technologies has also announced plans to submit its next-generation sequencing instrument, the Ion Torrent Personal Genome Machine (PGM™) for 510(k) clearance.

The Applied Biosystems™ 3500 Dx/3500xL Dx CS2 Genetic Analyzers, Invitrogen SeCore® HLA Sequencing Kits, and uTYPE® Dx HLA Sequence Analysis Software constitute the first 510(k)-cleared, sequence-based system for HLA typing in the United States. Tissue typing is an essential component of determining compatibility between donors and patients for organ and bone marrow transplantation. HLA typing on the 3500 Dx offers labs an optimized, streamlined workflow with higher resolution than other molecular HLA typing technologies such as sequence-specific oligonucleotide (SSO) methods.

"With clearance of this system, transplant patients can now have the confidence that their HLA tissue typing was performed utilizing a thoroughly tested, high resolution technique that has passed the strict test requirements of the FDA," said Ronnie Andrews, president of medical sciences at Life Technologies. "Precise HLA matching between donor and patient significantly improves overall transplant survival."

The 3500 Dx is now the only 510(k)-cleared Sanger sequencer commercially available for the diagnostics market. Sanger, also known as capillary electrophoresis, sequencing is the technology that powered the Human Genome Project and remains the "gold-standard" for its accuracy, reliability and ease of use.  It is expected that clearance will facilitate development of additional assays using the 3500 Dx and open up new partnerships with assay developers.

"Sanger sequencing remains the gold standard for providing the reliable results clinical labs need, and 510(k) clearance of the 3500Dx will help to establish sequencing technology as a mainstay of the hospital lab," said Andrews. "The instrument was designed with the clinical laboratory in mind, featuring a novel design that incorporates the ability to track reagent usage with radio frequency identification (RFID) tags, as well as redesigned data collection and analysis software."

Products included in the current 510(k) clearance are the 3500 Dx/3500xL Dx Genetic Analyzers CS2; 3500 Dx Series Data Collection Software v1.0; SeCore® HLA Sequencing Kits; and uTYPE® Dx HLA Sequence Analysis Software. The 3500 Dx instrument is CE-marked for in vitro diagnostic use in Europe, has been approved by China's State Food and Drug Administration (SFDA) for diagnostic use in China, and is also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan.

Additional products offered by Life Technologies for the diagnostics lab market include: the Applied Biosystems QuantStudio™ Dx Real-Time PCR Instrument, which is CE-IVD marked for use in Europe and under review by FDA; the Veriti™ Dx Thermal Cyclers; and the AcroMetrix® line of quality controls for molecular diagnostic assays. In addition, the EZ Validation™ Online Tool is available for assisting in the validation and verification of molecular tests.

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 2,800+ scientific posters on ePosters
  • More than 4,000+ 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 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
Ancient Viral Molecules Essential for Human Development
Genetic material from ancient viral infections is critical to human development, according to researchers at the Stanford University School of Medicine.
Measuring microRNAs in Blood to Speed Cancer Detection
A simple, ultrasensitive microRNA sensor holds promise for the design of new diagnostic strategies and, potentially, for the prognosis and treatment of pancreatic and other cancers.
Best Test to Diagnose Strangles in Horses Identified
New research by Dr. Ashley Boyle of New Bolton Center’s Equine Field Service team shows that the best method for diagnosing Strangles in horses is to take samples from a horse’s guttural pouch and analyze them using a loop-mediated amplification (LAMP) polymerase chain reaction (PCR) test.
Tardigrade's Are DNA Master Thieves
Tardigrades, nearly microscopic animals that can survive the harshest of environments, including outer space, hold the record for the animal that has the most foreign DNA.
Rapid, Portable Ebola Diagnostic
Scientists confirmed the efficiency of the novel Ebola detection method in field trials.
Detecting When Hormone Treatment for Breast Cancer Stops Working
Scientists have developed a highly sensitive blood test that can spot when breast cancers become resistant to standard hormone treatment, and have demonstrated that this test could guide further treatment.
Packaging and Unpacking of the Genome
New research improves understanding of the importance of histone replacement.
New Way to Find DNA Damage
University of Utah chemists devised a new way to detect chemical damage to DNA that sometimes leads to genetic mutations responsible for many diseases, including various cancers and neurological disorders.
How Different Treatments for Crohn's Effect the Microbiome
Different treatments for Crohn's disease in children affects their gut microbes in distinct ways, which has implications for future development of microbial-targeted therapies for these patients, according to a study led by researchers from the Perelman School of Medicine at the University of Pennsylvania.
Charting the 'Genomic Biography' of Leukemia
A new study by scientists at Dana-Farber Cancer Institute and the Broad Institute of MIT and Harvard offers a glimpse of the wealth of information that can be gleaned by combing the genome of a large collection of leukemia tissue samples.
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos