GE Healthcare today announced results from two studies that show how using the MultiOmyx™ Hodgkin Lymphoma (HL) Profile and an investigational profile for breast cancer may improve assessment of the two diseases in subsets of patients.
“These data show how using MultiOmyx can empower pathologists and oncologists to gain a much deeper understanding of what can be seen in a tumor, on a slide, region of interest or at a cellular level in a variety of cancers,” said Christine Kuslich, PhD, Chief Scientific Officer, In Vitro Diagnostics, GE Healthcare Life Sciences. “The ability to multiplex and visualize the contextual relationship between key proteins in the same cells from a single piece of tissue will help investigators answer questions they previously did not have the tools for. We can now investigate complex protein networks without disrupting their cellular relationship to the surrounding tissue.”
MultiOmyx is a ground-breaking pathology platform from Clarient Diagnostic Services, a GE Healthcare Company, which uses proprietary methodology to assess multiple proteins in a tissue section at a single-cell level, while preserving tissue context. In addition to the global service offering for clinical suspected Hodgkin lymphoma cases, the MulitOmyx services are also available to pharmaceutical, biotechnology and academic research organizations for research purposes through Clarient’s newly-opened MultiOmyx service laboratory.
“Traditional pathology uses multiple slices from paraffin-fixed tumor samples and examines them slide by slide, which is less efficient and effective,” said Kenneth Bloom, MD, Chief Medical Officer, Clarient Diagnostic Services, Inc. “Using a single slide may save time overall, 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 perform accurate and broad tumor analyses, while eliminating today’s need to prioritize tests due to limited tissue availability.”
The studies will be presented at the 55th Annual Meeting of the American Society of Hematology (ASH) and the 2013 San Antonio Breast Cancer Symposium (SABCS).
About the Studies
The study presented at ASH assessed CD30-positive cells with eight additional antibodies on the same cells of interest from formalin- fixed, paraffin-embedded tissue as an aid to diagnose Hodgkin lymphoma in a series of 23 cases. In addition, 56 unique cases were studied for diagnostic concordance. The study compared historical diagnosis using immunohistochemistry to the MultiOmyx assessment, studying blinded cases of classical Hodgkin lymphoma and other differential diagnosis entities and found 54 of the 56 cases showed complete concordance with the disparate cases favoring the MultiOmyx supported assessment.. Results from the study found that the MultiOmyx single slide assay has similar staining characteristics and is at least equivalent to standard immunohistochemical stains, allowing for better correlation of results between stains in a given case, particularly in cases with rare Hodgkin cells, since it allows direct comparison of stains within the same field of view and on the same cells.
Separately, results from an exploratory study to be presented at SABCS evaluate 25 known biomarkers on a cohort of more than 800 breast cancer cases assembled onto three tissue arrays to assess the ability of a MultiOmyx profile to screen for prognostic indicators of breast cancer. These studies add to the growing body of evidence supporting the efficacy of the MultiOmyx platform, including posters presented earlier this year at the annual meetings of the Association of Molecular Pathology (AMP), United States and Canadian Academy of Pathology (USCAP) and American Society of Clinical Oncology (ASCO), as well as the 9th International Society of Hodgkin Lymphoma and 15th World Congress on Lung Cancer.
About The Hodgkin Lymphoma Profile by MultiOmyx
The Hodgkin Lymphoma Profile by MultiOmyx has been commercially available since July 2013 as a consult service through Clarient Diagnostic Services, Inc. and 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 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.
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.
About Clarient Diagnostic Services, Inc.
Clarient Diagnostic Services, Inc. (clarientinc.com) is CLIA and NYS licensed, CAP accredited and a leading provider of comprehensive, cancer diagnostic laboratory services. With its advanced technologies, Clarient is able to provide pathologists and oncologist with more accurate and detailed information to better characterize and assess cancer which can lead to more accurate diagnoses and more effective treatment. In addition, Clarient’s services are finding more efficient ways to reduce the cost as well as accelerating the drug development process to identify and develop treating pharmaceuticals that can result in better outcomes for patients.
From its state-of-the-art diagnostic laboratory to its Internet-based PATHSiTE®, Clarient delivers advanced oncology diagnostic services to pathologists, oncologists, hospitals and biopharmaceutical companies throughout the U.S. Clarient also is developing tests for therapeutics in breast, prostate, lung and colon cancers, as well as leukemia/lymphoma.
Clarient is improving the lives of those affected by cancer by bringing clarity to a complex disease.
About GE Healthcare
GE Healthcare (gehealthcare.com) provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.