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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

Caris Life Sciences ASCO Presentation Highlights the Utility of Molecular Profiling for the Management of Rare and Aggressive Cancers

Caris Life Sciences™, a leading biosciences company focused on fulfilling the promise of personalized medicine, presented findings yesterday at the 2013 ASCO annual meeting from the analysis of its Caris Molecular Intelligence™ database. This database examined the results of molecular profiling of both common and rare cancer types for the identification of potentially clinically actionable targets.

For the purposes of this study, 42,000 patient tumors were analyzed in total, covering 150 histological subtypes received from more than 6,400 physicians worldwide. Furthermore, 14,700 of these cases, or 35 percent of the tumors profiled, are typically categorized as “rare” tumors, a patient segment that is typically underserved by current guidelines and where molecular profiling has the potential to significantly impact patient care.

Breaking the data down by tumor type, these findings included profiling the following tumor types:

  • 6,000-plus Ovarian cancers
  • 5,000-plus Breast cancers
  • 6,000-plus Non-small-cell lung cancers
  • 5,000-plus Colorectal cancers
  • 2,000-plus Pancreatic cancers
  • 14,000-plus Rare cancers

Caris has remained technology-agnostic in its approach to tumor profiling, employing a wide range of profiling technologies to uncover a broad array of key biomarkers, based upon review of the latest clinical literature showing correlations to known therapies. Technologies utilized for this comprehensive database included mutational analysis by Sanger Sequencing, Next-Generation Sequencing, Polymerase Chain Reaction (PCR), Gene Copy Number alterations and translocations by Fluorescent In Situ Hybridization/Chromogenic In Situ Hybridization (FISH/CISH), Methylation analysis, and protein expression by immunohistochemistry (IHC).

“To date, Caris has profiled nearly 50,000 patients, which is the largest and most comprehensive collection of biomarker profiles in the industry today,” said Zoran Gatalica , M.D., DSc, Executive Medical Director at Caris Life Sciences, and a lead researcher in this study. “This study provided critical insights into the distribution of common and rare genetic and protein alterations, with direct and potential treatment implications. Our multi-technology approach to tumor profiling has been critical to building this extensive database, as it provides the most meaningful biomarker analysis and thorough interrogation of the cancer pathways.”

Daniel Von Hoff , M.D., FACP, of the Translational Genomics Research Institute (TGen) in Phoenix, Ariz., presented results from its study, Integrating Molecular Profiling Into Cancer Treatment Decision Making: Experience With Over 35,000 Cases, at this year’s ASCO annual meeting.

“Because of the size and depth of this database, these data points hold significant potential to detect rare molecular aberrations and biomarker targets in patients with common or rare cancers,” said Dr. Von Hoff , Physician in Chief and Director of Translational Research at TGen; Professor of Medicine at both Mayo Clinic, Scottsdale and the University of Arizona College of Medicine; and Chief Scientific Officer at Scottsdale Healthcare and US Oncology. “The developmental and potential clinical applicability and relevance of tumor profiling is particularly compelling in cases of rare or resistant tumors, where treatment guidelines are more limited and current clinical trial data is often insufficient.” Dr. Von Hoff’s presentation was held Sunday, June 2, 2013, at 8:15 a.m. at E-354 B.

Source: PR Newswire

bioTheranostics’ CancerTYPE ID® More Accurate than Immunohistochemistry in Diagnosing Metastatic Tumors

bioTheranostics’ CancerTYPE® ID molecular cancer classifier demonstrated superior accuracy compared with immunohistochemistry (IHC) in identifying the primary site in difficult-to-diagnose metastatic tumors. The comparative effectiveness study, which was published recently in The Journal of Molecular Diagnostics, is the first comprehensive investigation to directly compare the diagnostic accuracy of the two tumor classification techniques.

“Timely, accurate, and definitive diagnosis is the critical first step, particularly as patient outcomes continue to improve with appropriate site-specific and molecular-targeted therapies. We are delighted to see CancerTYPE ID’s superiority in performance compared with the standard-of-care IHC.”
In this blinded study conducted in collaboration with the City of Hope National Medical Center, high-grade, primarily metastatic tumors considered diagnostically challenging were selected by lead investigators Lawrence M. Weiss, M.D., and Peiguo Chu, M.D. Performance of CancerTYPE ID for diagnosis of tumor type was directly compared with IHC analysis in 122 cases. Results were scored using reference diagnoses established by detailed clinical correlation.

In these difficult-to-diagnose cancers, CancerTYPE ID, a 92-gene RT-PCR assay, demonstrated a statistically significant improvement of 10 percent in overall accuracy compared with IHC (p=0.019). Performance differences favoring CancerTYPE ID were more than 20 percent when greater than nine IHC stains were used, likely due to the poorly differentiated nature of the cancers. These findings highlight CancerTYPE ID’s immediate clinical utility when an initial IHC panel does not lead to a definitive diagnosis, and when tumor specimen is limited and expanded IHC testing is likely to exhaust tissue that may be needed for predictive biomarker testing.

More than 400,000 patients present with metastatic cancer each year in the United States. Metastatic cancers of unknown or uncertain primary origin pose significant challenges for physicians to select appropriate therapies. “Precision Medicine involves individualized patient care based on tumor biology,” said Richard Ding, CEO of bioTheranostics. “Timely, accurate, and definitive diagnosis is the critical first step, particularly as patient outcomes continue to improve with appropriate site-specific and molecular-targeted therapies. We are delighted to see CancerTYPE ID’s superiority in performance compared with the standard-of-care IHC.”

Ding said that this study, together with another recent study showing favorable survival outcomes when physicians use the molecular classifier to direct selection of site-specific therapy, supports the use of CancerTYPE ID as a standardized diagnostic tool in difficult-to-diagnose metastatic cancers.

The study, “Blinded Comparator Study of Immunohistochemical Analysis versus a 92-Gene Cancer Classifier in the Diagnosis of the Primary Site in Metastatic Tumors,” can be accessed here. Preliminary results of the study were reported at the 2012 American Society of Clinical Oncology meeting.

Study: Blinded Comparator Study of Immunohistochemical Analysis versus a 92-Gene Cancer Classifier in the Diagnosis of the Primary Site in Metastatic Tumors

Source: Business Wire

Rosetta Genomics Announces Acceptance for Publication of Kidney Cancer microRNA Diagnostic Manuscript by Molecular Oncology

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, recently announced that a manuscript regarding the development and validation of the Company’s microRNA-based diagnostic assay for the classification of renal cell tumors has been accepted for publication by Molecular Oncology. Yael Spector, a scientist from Rosetta Genomics, and Dr. Eddie Fridman , a pathologist and an expert in urological pathology from Sheba Medical Center in Tel-Hashomer, Israel, are the lead authors on the manuscript.

An unedited version of the manuscript is available online ahead of print publication of the final article at http://www.sciencedirect.com/science/article/pii/S157478911300046X.

The manuscript discusses the development and validation of the miRview® kidney assay, which differentiates between the four main types of primary kidney tumors: the three subtypes of renal cell carcinoma (RCC) namely clear cell, papillary and chromophobe RCC, and typically benign behaving oncocytoma. The assay was developed on a microarray platform using 181 training samples and validated on an independent set of 201 samples. The assay provided results for 92% of the validation samples, with 95% accuracy.

The topic of this manuscript will also be summarized in a poster to be presented on April 7 at the American Association for Cancer Research (AACR) Annual Meeting 2013 in Washington, D.C.

“There are an estimated 65,000 new cases of kidney cancer each year in the U.S. and more than 13,000 deaths. Distinguishing between the four main types of primary kidney tumors is critical in determining the optimal treatment regimen,” said Kenneth A.

Berlin , President and Chief Executive Officer of Rosetta Genomics. “Our miRview® kidney assay accurately classifies clear cell RCC, papillary RCC, chromophobe RCC and oncocytoma. We are delighted that this work has been accepted for publication in Molecular Oncology, an important industry trade journal.”

“The classification into subtypes of RCC has historically been less than definitive by histology, cytology and immunohistochemistry particularly in the growing context of fine needle aspirate (FNA) diagnostic specimens. The discrimination of the four subtypes can lead to the avoidance of aggressive surgical intervention in oncocytomas, and the others have differing biological behaviors that can be correlated with subtype. Importantly, newer therapeutic agents may show evidence of specificity of response by cell type. The expanded clarity of RCC diagnosis through the availability of this test will help lead to improved rationalization and optimization of new and emerging therapies, particularly in the community setting,” said Bob Wassman , M.D., Chief Medical Officer of Rosetta Genomics.

Source: PR Newswire

Definiens and Advanced Cell Diagnostics Introduce RNAscope SpotStudio – Early Access Program Started

Definiens and Advanced Cell Diagnostics (ACD) recently unveiled the details of the RNAscope SpotStudio image analysis software to attendees at the Molecular Medicine Tri-Conference meeting in San Francisco, USA. The software has already been sold to a top pharmaceutical company and a leading academic medical center under an early access program. This advanced image analysis solution brings objective and accurate quantification to RNA in situ hybridization and enables a new generation of diagnostic applications based on single cell analysis. For the first time, gene expression can be measured quantitatively at single-cell resolution and interpreted by pathologists within histopathological context.

Empowering Pathologists with an Easy-to-Use Tool for Quantitative Biomarker Analysis

Quantitative RNA in situ hybridization analysis has recently been made possible by the single molecule sensitivity and digital nature of RNAscope® assay technology. However, manual scoring is time consuming and prone to subjectivity and poor reproducibility. RNAscope SpotStudio software is designed for pathologists with no prior training in image analysis. It is an intuitive automated solution that generates standardized and objective results in minutes. Testing has shown that results obtained with RNAscope SpotStudio are comparable to careful manual annotations by pathologists. The software is compatible with image data from whole slide scanners and microscopes.

“In situ biomarker analysis tools such as immunohistochemistry (IHC) have been limited to subjective semi-quantitative scoring. RNAscope and the SpotStudio image analysis software take in situ biomarker analysis to a whole new level, where quantitative data at the single cell level can be obtained and interpreted within the histopathological context of the clinical specimen”, said Yuling Luo, Founder, President and CEO of ACD. “RNAscope combines the advantages of IHC and PCR, making it a superior tool for tissue-based diagnostics and companion diagnostics”, Dr. Luo added. “Definiens’ invaluable expertise with tissue image analysis made it an ideal partner for the joint development of RNAscope SpotStudio.”

“Coming from a leading position in providing image analysis solutions to the life sciences market, Definiens is rapidly expanding its footprint in tissue diagnostics. We are very excited about this partnership with ACD representing a great example of advanced diagnostic solutions based on Definiens image and data analysis capabilities that will drive next generation diagnostics to truly enable personalized medicine”, said Thomas Heydler, CEO of Definiens.

Definiens and ACD will showcase RNAscope SpotStudio at the Molecular-Med Tri-Con in San Francisco (booth 210). The solution will be marketed and distributed by ACD and is currently being distributed to selected customers in an early access program. General availability is planned for the second quarter of 2013.

While RNAscope Spot Studio supports the analysis of brightfield images, RNA FISH assays can be quantified with Definiens Tissue Studio. With over 450 deployed licenses, Definiens Tissue Studio is the leading image analysis solution for digital pathology. Beyond the detection of spot-like stains, Definiens Tissue Studio provides morphological and molecular expression profiles from any solid tissue (IHC and IF) on a cell-by-cell basis.

Source: Definiens