A Medical Device Daily

NanoString Technologies (Seattle), a maker of a complete solution for detecting and counting large sets of target molecules in biological samples, said it has secured an exclusive worldwide license from Bioclassifier technology to develop in vitro diagnostic and research products for breast cancer intrinsic subtyping. The company also stated its goal to become the platform of choice for diagnostic testing based on multiplexed gene expression signatures that can be offered in hospitals and pathology laboratories worldwide, following appropriate regulatory approvals.

More than a decade of research, clinical studies, and peer reviewed publications support the value of intrinsic subtyping based on gene expression analyses to assess prognosis and treatment options for breast cancer patients. The Bioclassifier team, a partnership of four breast cancer experts from four leading research institutions, has advanced this field by creating and validating the PAM50 gene signature. The NanoString Breast Cancer Intrinsic Subtyping Assay will be based on the PAM50 gene signature and will be designed to measure the expression levels of these 50 genes in formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue samples.

Research suggests that the subtype classification and prognostic score generated by the PAM50 gene signature provides information about the fundamental biology of breast cancer that cannot be gained through other currently available diagnostic tests. It may provide clinically useful information for a broader range of breast cancer subtypes, including classification of tumors from patients with estrogen receptor negative, or node positive forms.

In other agreements/contracts news:

• Cerner (Kansas City) and Baxa (Englewood, Colorado) have signed a strategic reseller agreement for the Baxa DoseEdge Pharmacy Workflow Manager. The agreement enables Cerner to market and resell the Baxa DoseEdge system as part of an integrated Cerner offering. Cerner clients now have access to a broader suite of solutions and certified integration for dose tracking from compounding to delivery.

The Cerner partnership will allow health systems to improve their IV room automation by integrating DoseEdge technology with Cerner solutions to create a closed-loop system for medication preparation, management and delivery. DoseEdge connects to the Cerner CareAware Infusion Management and Cerner Millennium PharmNet solutions to move critical IV mixing data to the electronic health record.

“The agreement expands our offering and positions Cerner to continue increasing interoperability across the medication process,“ said Tom Herzog, Cerner VP, IT and medical device technologies. Dennis Schneider, Baxa senior VP of marketing and business development, adds, “Together, the Baxa and Cerner solutions increase IV room efficiency and advance patient safety. Their interoperability will reduce drug waste and improve communication about patient doses between pharmacy and nursing.“

Cerner solutions optimize processes for healthcare organizations ranging in size from single-doctor practices, to health systems, to entire countries, for the pharmaceutical and medical device industries, employer health and wellness services industry and for the healthcare commerce system.

• Premier Purchasing Partners (Charlotte, North Carolina) reported new agreements for automated microbial identification and susceptibility analyzers, reagents, consumables and service have been awarded to bioMerieux (Durham, North Carolina), and Siemens Healthcare Diagnostics (Deerfield, Illinois).

The agreements are available to acute care and continuum of care members of the Premier healthcare alliance.

Additionally, Premier has launched the QUEST Comparative Effectiveness & Innovation Program (QCEIP).

Baxter International (Deerfield, Illinois), Lantheus Medical Imaging (N. Billerica, Massachusetts) and Siemens Healthcare Diagnostics (Deerfield, Illinois) have been selected to participate in QCEIP, a voluntary program that will test products and clinical interventions in real-world settings at Premier alliance hospitals. QCEIP will work to generate objective results to help the provider community better understand the patient outcomes associated with the use of certain products.

The aim of CER – and QCEIP – is to improve health outcomes by developing and disseminating evidence-based information about the effectiveness of treatments relative to other options.