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GE Healthcare Launches its First “Next-Generation” Sequencing Assay

GE Healthcare recently announced that Clarient Diagnostic Services, Inc., a GE Healthcare company, will begin offering a next-generation sequencing assay focused on solid tumor targets for use in clinical trials. This assay will empower researchers to perform prospective and retrospective analysis to better understand which patients will respond to particular therapies, to help stratify patient populations for ongoing clinical trials, and to aid early research efforts.

NanoString Launches Its First Commercial Diagnostic Product in the European Union and Israel

NanoString Technologies, Inc., a privately held provider of life science tools for translational research and molecular diagnostic products, today announced it has launched its first commercial in vitro diagnostic product, the Prosigna™ Breast Cancer Prognostic Gene Signature Assay for the nCounter® diagnostic system in the European Union (EU) and Israel.

Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna assay provides a subtype classification based on the fundamental biology of an individual’s breast tumor (referred to as intrinsic subtyping), and a prognostic score (referred to as the risk of recurrence, or ROR, score). The ROR score estimates the probability of cancer recurrence by 10 years in post-menopausal women with hormone receptor-positive early-stage breast cancer who have been treated with endocrine therapy alone. The Prosigna assay was validated in two clinical studies with more than 2,400 patient samples and results were presented at the 2011 and 2012 San Antonio Breast Cancer Symposium.

The Prosigna assay requires minimal hands-on time and can be offered through qualified pathology laboratories, empowering oncologists and pathologists to manage the diagnostic evaluation of breast cancer patients locally. The Prosigna assay runs on NanoString’s proprietary nCounter system, which offers a simple, reproducible and cost-effective way to profile hundreds of targets simultaneously with high sensitivity and precision. The nCounter Analysis System is currently available for “Research Use Only” in North America.

“Prosigna provides physicians and their patients access to analytically and clinically validated genomic information that can impact important treatment decisions, without the need to send precious samples to a centralized reference lab that may be overseas,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Our launch in the European Union and Israel marks the beginning of our efforts to market Prosigna globally. This is a significant milestone for NanoString as we launch our commercial diagnostics business and work toward additional regulatory marketing authorizations.”

J. Wayne Cowens, M.D., Chief Medical Officer for NanoString Technologies added: “I would like to extend my heartfelt thanks to the investigators and patients who participated in the two pivotal trials for Prosigna. We look forward to making Prosigna available to the many breast cancer patients in need throughout the European Union and Israel.”

Source: Business Wire

Thermo Fisher Scientific Enters into a Long-Term Agreement with Fujirebio Inc. to Strengthen Availability of Biomarker Procalcitonin (PCT)

Thermo Fisher Scientific Inc., the world leader in serving science, recently announced it has signed a long-term license agreement with Fujirebio Inc. to make its biomarker assay Procalcitonin (PCT) available on the Lumipulse™ family of laboratory instruments, using the chemiluminescent enzyme immunoassay (CLEIA) technology. The agreement focuses on Japan, where Fujirebio’s Lumipulse product line is placed in a significant number of hospitals and clinical reference labs and will be extended with future placements of Lumipulse platforms in other markets worldwide.

Agenix to Acquire Diagnostic Device Technology from Tyrian Limited

Agenix Limited (ASX: AGX) today announced it had entered an agreement with Tyrian Diagnostics Limited (ASX: TDX) to license its rapid point-of-care human diagnostic technology in a share exchange transaction.

QIAGEN and Bayer HealthCare Partner to Develop Companion Diagnostics to Guide Treatment Decisions for Targeted Cancer Therapies

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) and Bayer HealthCare today announced a collaboration agreement for the development and commercialization of companion diagnostics paired with novel Bayer HealthCare drugs, initially to enhance the treatment of various solid tumors. Companion diagnostics are tests that unlock molecular information from each patient’s tumor genome to guide treatment decisions with medications for cancers or other diseases. The parties will also collaborate on the development of novel technologies for patient profiling which may result in innovative research-use-only products for exploratory and translational medicine. Financial details were not disclosed.