Nanotechnology Now

Our NanoNews Digest Sponsors





Heifer International

Wikipedia Affiliate Button


android tablet pc

Home > Press > NanoString Technologies Obtains CE Mark for PAM50-based Test for Breast Cancer: Testing Kit Available in Early 2013 Will Offer EU Patients Risk of Recurrence Score and Intrinsic Subtyping

Abstract:
NanoString Technologies, Inc., a privately held provider of life science tools for translational research and developer of molecular diagnostics, today announced it has obtained the CE Mark for its PAM50-based gene expression test for breast cancer, clearing the company to sell its test in the European Union and other countries recognizing the CE Mark.

NanoString Technologies Obtains CE Mark for PAM50-based Test for Breast Cancer: Testing Kit Available in Early 2013 Will Offer EU Patients Risk of Recurrence Score and Intrinsic Subtyping

Seattle, WA | Posted on September 27th, 2012

NanoString's test provides a subtype classification based on the fundamental biology of an individual's breast tumor (referred to as intrinsic subtyping), as well as a prognostic score that predicts the probability of cancer recurrence over 10 years in post-menopausal women with hormone receptor-positive, early stage breast cancer (ESBC) who have been treated with hormonal therapy. Together with studies from the literature, this information has been shown to convey valuable information about a patient's prognosis that can inform critical decisions about the patient's course of therapy.

"We are delighted to complete our first regulatory filing for our PAM50-based gene expression diagnostic test for breast cancer less than two years after beginning our rigorous clinical development program," said Bruce Seeley, Senior Vice President & General Manager, Diagnostics at NanoString Technologies. "Women and their clinicians in countries that accept the CE Mark will soon have a new option for informing important treatment decisions, and for bringing more certainty to those decisions. This filing is right on the heels of the landmark study from The Cancer Genome Atlas that demonstrated the power of the PAM50 for subtyping breast cancer into four distinct diseases, and importantly the clinical use of intrinsic subtyping is already included in the St. Gallen International Breast Cancer Treatment Guidelines."

NanoString intends to begin marketing its breast cancer test in major markets that accept the CE Mark in early 2013. The company has a worldwide license for the PAM50 gene signature to develop in vitro diagnostic and research products for breast cancer on its nCounter® Analysis System. The clinical development program for NanoString's PAM50-based breast cancer test is designed to support both regulatory requirements for market-specific approval and its incorporation into worldwide breast cancer treatment guidelines.

"PAM50 on the nCounter platform represents the next generation in genomic testing for breast cancer, providing a powerful new tool for reliable and accurate genomic testing that can be done in local laboratories in countries that recognize the CE Mark," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "This regulatory filing is an important milestone in NanoString's vision to support the global democratization of genomic testing, and make high-impact gene-profiling tests widely available as in vitro diagnostic products. We extend heart-felt congratulations and gratitude to our collaborators who contributed to this achievement."

The CE Mark is based on positive results from NanoString's first clinical validation study, as well as a recently completed multi-site analytical validation study. The results of the clinical validation study, which included more than 1,000 samples from the TransATAC study of postmenopausal women with hormone receptor-positive early-stage breast cancer (ESBC), were presented by the study's independent investigators at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The results of the multi-site analytical validation study are expected to be presented at a major clinical meeting during 2013.

The test that is the subject of the CE Mark is available in the United States as Investigational Use Only. The test runs on the nCounter system, which is presently offered in the United States as Research Use Only, and is not intended for diagnostic use in the United States.

####

About NanoString Technologies, Inc.
NanoString Technologies is a privately held provider of life science tools for translational research and developer of molecular diagnostics. The company’s nCounter Analysis System is the first and only technology platform to deliver highly multiplexed, direct profiling of individual molecules in a single reaction without amplification. The nCounter Analysis System offers a cost-effective way to easily profile hundreds of gene transcripts, copy number variations, or miRNAs simultaneously with high sensitivity and precision. The company’s technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. NanoString is also developing the technology for use in molecular diagnostics.

The NanoString Technologies design logo, NanoString, NanoString Technologies and nCounter are registered trademarks of NanoString Technologies, Inc. All other trademarks are property of their respective owners.

For more information, please click here

Contacts:
For NanoString Technologies
Nicole Litchfield
415-793-6468

Copyright © Business Wire

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

The International Space Elevator Consortium (ISEC) is proud to announce the 2014 Space Elevator Conference! This annual event will be held at the Museum of Flight in Seattle, Washington from Friday, August 22nd through Sunday, August 24th August 19th, 2014

KaSAM-2014 International Conference (September 7-10, 2014, Kathmandu, Nepal) August 19th, 2014

Success in Intracellular Imaging of Cesium Distribution in Plants Used for Cesium Absorption August 19th, 2014

Electrical engineers take major step toward photonic circuits: Team invents non-metallic metamaterial that enables them to 'compress' and contain light August 19th, 2014

Products

QuantuMDx announce prototype handheld lab for 15 minute malaria diagnosis and drug resistance testing April 23rd, 2014

Nanovations Sets new Benchmark in Automotive Windscreen Coating Durability: Nanovations new automotive glass coating Vision Protect, sets new benchmark in glass coating durability March 23rd, 2014

Tawada CleanTech to show fabric duct and eco cool coating in MegaBuild March 21st, 2014

NEI Introduces Self-healing Anti-corrosion Coating for Zinc-Plated and Galvanized Steel March 14th, 2014

Govt.-Legislation/Regulation/Funding/Policy

Success in Intracellular Imaging of Cesium Distribution in Plants Used for Cesium Absorption August 19th, 2014

Electrical engineers take major step toward photonic circuits: Team invents non-metallic metamaterial that enables them to 'compress' and contain light August 19th, 2014

Promising Ferroelectric Materials Suffer From Unexpected Electric Polarizations: Brookhaven Lab scientists find surprising locked charge polarizations that impede performance in next-gen materials that could otherwise revolutionize data-driven devices August 18th, 2014

Novel chip-based platform could simplify measurements of single molecules: A nanopore-gated optofluidic chip combines electrical and optical measurements of single molecules onto a single platform August 14th, 2014

Nanomedicine

Graphene rubber bands could stretch limits of current healthcare, new research finds August 19th, 2014

Interaction between Drug, DNA for Designing Anticancer Drugs Studied in Iran August 17th, 2014

Scientists fold RNA origami from a single strand: RNA origami is a new method for organizing molecules on the nanoscale. Using just a single strand of RNA, this technique can produce many complicated shapes. August 14th, 2014

Iranian Scientists Stabilize Protein on Highly Stable Electrode Surface August 14th, 2014

Announcements

Сalculations with Nanoscale Smart Particles August 19th, 2014

Life on Mars? Implications of a newly discovered mineral-rich structure August 19th, 2014

Harris & Harris Group Letter to Shareholders on Website August 19th, 2014

Electrical engineers take major step toward photonic circuits: Team invents non-metallic metamaterial that enables them to 'compress' and contain light August 19th, 2014

Tools

Oxford Instruments Asylum Research Receives the 2014 Microscopy Today Innovation Award for blueDrive Photothermal Excitation August 18th, 2014

Laser makes microscopes way cooler: Cooling a nanowire probe with a laser could lead to substantial improvements in the sensitivity of atomic force probe microscopes August 15th, 2014

JPK reports on the use of AFM and advanced fluorescence microscopy at the University of Freiburg August 13th, 2014

Phasefocus reports on the use of their high-precision Lens Profiler for measuring contact lens thickness at the Brien Holden Vision Institute in Sydney, Australia August 13th, 2014

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More














ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE