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June 2012: Diagnostic testing / reagents

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Diagnostic Testing and Reagents in the Age of Molecular Pathology
Jaleh Mansouri, M.D.


The increasing number of molecular pathology tests performed today for diagnostic, prognostic and therapeutic purposes has introduced a new set of complex issues regarding the oversight of both home brew (in-house) and manufacturer kit-based tests. While most analyte specific reagents (ASRs) do not currently require approval by the US Food and Drug Administration (FDA), laboratories developing higher complexity tests (e.g. fluorescence in situ hybridization, FISH), must be certified under the Clinical Laboratory Improvement Amendments (CLIA). These clinical laboratories retain the primary responsibility for establishing rigorous performance characteristics of a particular test prior to implementation and are required to issue appropriate disclaimers for ASRs.

In vitro diagnostic multivariate index assays (IVDMIA) are emerging as complex molecular tests which employ a number of ASRs including antibodies and genetic markers in order to provide more comprehensive and specific information on the prognostic, therapeutic and biologic course of the disease in question. These tests may eventually provide clinicians with a blueprint for individualized treatment of the patient. Examples of IVDMIAs approved by the FDA include MammaPrint (Agendia), Tissue of Origin Test (Pathworks Diagnostics), and AlloMap (XDx). The advent of IVDMIAs and other technologically advanced assays with critical diagnostic and therapeutic implications will likely redefine the validation and clearance protocols of regulatory agencies for clinical pathology laboratories.


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Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology. The companyÕs products and services are based on its proprietary RNAscope¨ technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single-molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers and to develop companion diagnostic tests for targeted therapeutic development in cancer and other diseases. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. For more information please contact info@acdbio.com or call 1-877-576-3636. Learn more at www.acdbio.com.

bioTheranostics discovers and develops innovative diagnostic technologies for oncology, designed to improve patient care from the time of diagnosis through selection of appropriate treatment. The company's initial diagnostic test offerings are: (1) CancerTYPE ID¨, which improves cancer classification, especially in patients with metastatic cancer and an unknown primary. It is based on a 92-gene qRT-PCR panel and capable of identifying up to 39 tumor types with 86% accuracy. (2) THEROS Breast Cancer Index® - This provides a more complete picture of recurrence risk and therapeutic options for patients by combining the results of the THEROS H/I and THEROS MGI tests, to better stratify ER-positive, node-negative breast cancer patients. bioTheranostics is also working on prostate cancer prognosis and drug-response profiling. Email Brittany.Rothnem@biotheranostics.com or call 858 587 5883 for more information.

Covance is a provider of gold standard Signet™ immunopathology antibodies, detection chemistries and ancillaries. Monoclonal and polyclonal antibodies are offered for immunohistochemistry on formalin-fixed paraffin-embedded tissues and for a variety of other assays. These antibodies are available in pre-diluted and concentrated formats, providing ease-of-use and reproducibility in both manual and automated staining. Detection chemistries, chromogens, counterstains and buffers are also available in a range of kit volumes to meet your laboratory needs. Covance’s antibody portfolio also includes antibodies for neurodegenerative disease, cell biology and a variety custom immunology services. For more information contact Angela Thomas, Immunopathology Product Manager, at 800.223.0796 or angela.thomas@covance.com. Visit our website at www.covance.com.

Epitomics is the world leader in rabbit monoclonal antibody (RabMAb®) technology. Using our proprietary RabMAb technology, we have developed high quality antibodies (EP Clones™) and IHC kits (EpiPrecision™, EpiVision™) for anatomical pathology use. With the benefits of RabMAb technology, EP Clones offers superior binding affinity and specificity. EP Clones have been specifically developed and optimized for use in pathology laboratories for immunohistochemical staining of formalin-fixed paraffin embedded tissues. We are committed to providing high quality products and services that consistently meet the needs of our customers. For more information contact us at 877-772-2622, IVDinfo@epitomics.com, or visit our website at www.epitomics.com/diagnostics.

Horizon Diagnostics is the world's first provider of genetically defined, human genomic reference standards, including FFPE cell line blocks, and purified genomic DNA. These standards offer a sustainable source of reference material to diagnostic laboratories, proficiency schemes, and manufacturers, and provide an unprecedented level of control to the molecular pathology community. Variability in DNA extraction from tumor biopsies and a lack of standardization are currently major sources of error in diagnostic laboratories. The availability of genetically defined controls will provide a gold standard for development and quality control of assays, directly improving analytical accuracy and clinical outcomes. Please visit our website at www.Horizondx.com for more information or contact us at info@horizondx.com.

Leica Microsystems is a leading global developer and manufacturer of a broad range of innovative, high-tech, precision optical systems for the imaging, measurement, and analysis of microstructures. Leica Microsystems is one of the market leaders in each of its four divisions: Life Science, Industry, Biosystems, and Surgical. Business areas include Microscopy and Imaging Systems, Specimen Preparation, Medical Equipment, and Antibodies and Reagents. The company offers instruments and system solutions for the entire histopathology process including the NovocastraTM range of antibodies and reagents, consumable products, and clinical microscopes. The company is represented in over 100 countries with 9 manufacturing facilities in 7 countries, sales and service organizations in 20 countries and an international network of dealers.

Ventana Medical is one of the world’s leading developers and manufacturers of medical diagnostic instrument and reagent systems providing leading-edge automation technology for use in slide-based diagnosis of cancer and infectious disease. Our products are found in hospital-based histology laboratories, independent reference laboratories, and the drug discovery laboratories of some of the world’s largest pharmaceutical and biotechnology companies, government labs, and medical research centers. For more information please visit our website at www.ventanamed.com or call us at 800.227.2155.


Past / future feature pages:

February 2012: Microscopes / slide imaging
March 2012: Tissue processors / other histology
April 2012: Laboratory Accreditation / Education / CME
May 2012: Computer software and systems

July 2012: Imaging / digital / photography
August 2012: Books & Journals
September 2012: Antibodies
October 2012: Laboratories
November 2012: Consumable Lab Products / Clinical Lab Analyzers
December 2012: Grossing workstations / lab furniture
January 2013: Billing / consulting / management
February 2013: Microscopes / slide imaging
March 2013: Tissue processors / other histology
April 2013: Laboratory Accreditation / Education / CME
May 2013: Computer software and systems
June 2013: Diagnostic testing / reagents

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