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Definiens Signs Agreement with Clarient to Offer Validated Solutions for Routine Clinical Pathology Testing

Definiens, the global leader in image analysis for digital pathology and diagnostics recently announced the signing of an agreement with Clarient Diagnostic Services, Inc.- which extends the use of Definiens’ automated image analysis software and solutions in Clarient’s validated clinical applications for immunohistochemistry testing in breast cancer. Definiens’ proprietary Cognition Network Technology® is core to automatically classify and quantitate key tissue features as part of Clarient’s Scope IA Platform offering to its pathology customers.

bioMerieux’s THxID-BRAF Test for Detection of 2 BRAF Mutations V600E and V600K in Late-Stage Metastatic Melanoma adopted by Clarient, a GE Healthcare Company

bioMerieux, Inc. and Clarient, a GE Healthcare Company recently announced that bioMerieux’s molecular diagnostic test THxID®-BRAF has been added to the service offerings provided by Clarient. Clarient will use THxID® BRAF in order to aid oncologists in selecting metastatic melanoma patients whose tumors carry the BRAF V600E mutation for possible treatment with GlaxoSmithKline’s (GSK) Tafinlar® (dabrafenib) as well as in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist™ (trametinib).

Clarient, A GE Healthcare Company, Introduces First Lab Developed Test To Assess Multiple Proteins at Single-Cell Level

GE Healthcare recently announced the introduction by Clarient Diagnostic Services, a GE Healthcare Company, of the first lab developed test using MultiOmyx™, a ground-breaking new pathology platform which uses proprietary methodology to assess multiple proteins from a single tissue section at a single-cell level. This test, now available, offers an aid to a pathologist’s diagnosis of CD30-positive lymphoma cases with difficult morphology or otherwise insufficient tissue to adequately evaluate the case.

“In many instances, suspected lymphoma cases are not straightforward, and sample tissue size inadequacy issues further complicate the matter,” said Lawrence Weiss, MD, Medical Director of Clarient. “In difficult to call diagnoses, MultiOmyx gives me great confidence in making the diagnosis and relieves me from the concern of running out of tissue. If I only have a small amount of tissue, I do not have to sacrifice or choose between important markers – I can assess them all.”

The Hodgkin Lymphoma (HL) Profile by MultiOmyx helps to assess nine unique antibodies (CD30, CD15, CD20, CD45, PAX5, OCT2, BOB1, CD3, and CD79A) on a single formalin fixed paraffin embedded tissue section to aid in differential diagnosis of Classical HL.

In clinical validation, this single slide assay called the Hodgkin Lymphoma Profile by MultiOmyx demonstrated high levels of accuracy, diagnostic reproducibility and repeatability, and high sensitivity of all immunofluorescent stains in comparison to traditional immunohistochemistry performed on the same samples. The correlation study identified unique cases where MultiOmyx demonstrated improved performance.

“Traditional pathology uses multiple slices from paraffin-fixed tumor samples and examines them slide by slide, which is less efficient and effective,” said Carrie Eglinton Manner, CEO, Clarient. “Using a single slide may save time, uses significantly less tissue and may provide a more consistent result. Since different parts of a tumor sample can act differently and because less tissue is required, pathologists can access the most accurate and broad tumor analysis available, while eliminating today’s need to prioritize tests due to limited tissue availability.”

The relevance of the MultiOmyx technology was recently confirmed in a clinical paper written by a team of scientists from GE Global Research published in Proceedings of the National Academy of Sciences (PNAS). The paper details the different ways GE is using image data to visualize cancer and the relationship between different biomarkers and the tumor environment and suggests the technology could be broadly applicable to problems in basic biological research, drug discovery and development and companion and clinical diagnostics.

“MultiOmyx provides clinicians and researchers with a novel biomarker multiplexing method to understand biological context in a way that is not possible with other technologies that disrupt the tissue histology. Once cells are removed from the context of their overall microenvironment with other methods valuable information is lost,” said Christine Kuslich, PhD, Chief Science Officer, In Vitro Diagnostics, GE Life Sciences. “MultiOmyx uniquely facilitates the ability to visualize multiple biological pathways, local immune response as well as heterogeneity of expression within regions of interest on a cell-by-cell basis from a single tissue section maintaining tissue context.”

The platform uses fluorescence to provide quantitative analysis of antibodies and allows for up to 60 proteins to be examined on a single tissue sample. It creates a “digital map” of the tumor, giving each cell an “address” and allowing for a clear graphic representation of protein expression. Matching this map to known biosignatures gives researchers a more accurate representation of the exact characteristics of the tumor and may provide clinicians with a clearer view to aid the diagnosis. It also allows them to identify patterns in the tissue by analyzing each cell and biomarker individually, or as a cluster, and thus get a level of understanding of the biological process that could not be achieved via traditional methods.

Study: Highly multiplexed single-cell analysis of formalin-fixed, paraffin-embedded cancer tissue

Source: Business Wire

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.

Definiens Establishes Advisory Board

Definiens, the global leader of image and data analysis solutions for quantitative digital pathology, recently announced it has appointed an Advisory Board comprising renowned industry experts and visionaries in digital pathology. As part of its market expansion strategy, Definiens established the new Board to provide independent advice on trends and opportunities in tissue diagnostics and clinical digital pathology.

Members of the Advisory Board include:

  • Ron A. Andrews, President, Medical Sciences, Life Technologies and former CEO of Clarient and CEO of GE Molecular Diagnostics
  • Prof. Uwe Bicker, Dean of the Medical Faculty Mannheim, University of Heidelberg and a member of the board of directors of Sanofi SA
  • Prof. Manfred Dietel, Director, Institute of Pathology, Charité Berlin and chairman of the German Society for Pathology
  • Eric F. Glassy, M.D., Medical Director, Pathology, Inc.and chairman of the Digital Pathology Working Group of the College of American Pathologists
  • Prof. Gerd Binnig, Founder and CTO, Definiens (Moderator)

“Definiens is working to advance personalized medicine by contributing to the development of next generation diagnostics, and bringing those novel diagnostics into clinical practice. Our innovations have the potential to transform daily clinical practice for the benefit of both patients and pathologists, particularly in oncology,” said Thomas Heydler, CEO of Definiens. “We will greatly benefit from the wealth of experience of the Advisory Board members while expanding our business into tissue diagnostics and clinical digital pathology.”

As part of its goal to guide Definiens during the company’s expansion, the Advisory Board will discuss trends in digital pathology and highlight opportunities for image and data analysis to revolutionize clinical practice in pathology. Specific topics of discussion will include pathology workflow, tissue diagnostic test development, personalized medicine and next-generation cancer treatment, as well as future technology and market requirements. Definiens founder and Nobel laureate, Professor Gerd Binnig, will catalyze the discussions.

“With the novel opportunities enabled by digital pathology, progress in diagnosing and treating cancer will be accelerated. The visionary power and expertise brought together in the Definiens Advisory Board will be invaluable on our path towards bringing advanced image analysis to clinical pathology,” said Prof. Gerd Binnig, Founder and CTO of Definiens.

Source: Definiens