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June 2013:
Diagnostic Testing / Reagents

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Diagnostic Reagents in Pathology: Quality Assurance
Jaleh Mansouri, M.D.

Diagnostic reagents comprise a critical component of the modern pathology laboratory due to the growing number of increasingly complex in vitro diagnostic tests that are available to clinicians. The performance characteristics of assays are determined, in part, by both the intrinsic quality of a reagent as well as proper quality control and assurance protocols established and practiced by the laboratory. Necessary quality control measures for diagnostic reagents include proper storage and handling, use before date of expiration, accurate record keeping, and lot-to-lot reagent testing and validation. Stored patient samples are often used to compare and validate the performance of reagents from successive lots, although external controls (i.e. from a manufacturer or reference lab) may be needed for more esoteric or complex assays.

Many vendors supplying diagnostic reagents and/or analytical instruments for various assays usually offer calibration standards and controls (i.e. reference samples) that are instrument-specific for internal calibration and validation by the pathology laboratory (e.g. Roche). Some companies may actually specialize in marketing products for quality control and standardization (e.g. AcroMetrix). In addition, software packages are available for constructing calibration curves and performing various calculations involved in validating reagents for more complex laboratory tests (e.g. quantitative PCR, DNA assays).

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Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology. The company's 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.

Epitomics - an Abcam Company 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.

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 Novocastra™ 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 2013: Microscopes / Microscopy Products
March 2013: Tissue Processors / Other Histology
April 2013: Laboratory Accreditation / Education / CME
May 2013: Computer Software and Systems
June 2013: Diagnostic Testing / Reagents

July 2013: Imaging / Digital / Photography
August 2013: Books & Journals
September 2013: Antibodies
October 2013: Laboratories
November 2013: Consumable Lab Products / Clinical Lab Analyzers
December 2013: Grossing Equipment / Workstations
January 2014: Billing / Consulting / Management
February 2014: Microscopes / Microscopy Products
March 2014: Tissue Processors / Other Histology
April 2014: Laboratory Accreditation / Education / CME
May 2014: Computer Software and Systems
June 2014: Diagnostic Testing / Reagents

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