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June 2014:
Diagnostic Testing / Reagents

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Diagnostic Reagents: The Potential Role of microRNAs
Jaleh Mansouri, M.D.

MicroRNAs are segments of noncoding RNA molecules comprised of approximately 21-22 nucleotides. In the past decade, microRNAs have been extensively studied and shown to have an important function in the regulation of gene expression. As modulators of gene expression, microRNAs have been implicated to play a role in oncogenesis. Interestingly, a number of studies have focused on generating prognostic molecular profile signatures in various types of cancers (e.g. chronic lymphocytic leukemia, non small cell carcinoma). Furthermore, microRNAs have a potential role as valuable serum biomarkers in cancer screening (e.g., miR-21 in colorectal cancer). Also, microRNAs may serve as specific therapeutic targets in cancer as well as other pathologic conditions due to their biologic function.

Despite these encouraging results, the implementation of microRNAs as part of routine diagnostic testing will be challenging as the validation of microRNA platforms is a complex procedure. A number of biotech and pharmaceutical companies (e.g., Affymetrix, Asuragen) offer microRNA profiling services in translational research settings as well as in the development of functional assays in collaboration with health facilities and universities. Given these developments, microRNAs hold much promise as prominent future diagnostic reagents in anatomic and clinical pathology as well as pharmacogenomics.

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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 IndexSM - 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.

Cell Marque is a quality supplier of a most valuable and innovative portfolio of antibodies suitable for immunohistochemistry on formalin fixed paraffin embedded tissues. Our main focus is on in vitro diagnostics. In the last few years, we have introduced over 100 antibodies to further serve the clinical market. We are passionate about manufacturing quality products. We bring dedication to our customers that can only come from a company whose focus is primarily on antibodies. To learn more about Cell Marque and the products we sell, contact us at 800.665.7284 or visit us online at www.cellmarque.com.

Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Click here for more information.

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 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

July 2014: Imaging / Digital / Photography
August 2014: Books & Journals
September 2014: Antibodies / Biomarkers
October 2014: Laboratories
November 2014: Consumable Lab Products / Clinical Lab Analyzers
December 2014: Grossing Equipment / Workstations
January 2015: Billing / Consulting / Management
February 2015: Microscopes / Microscopy Products
March 2015: Tissue Processors / Other Histology
April 2015: Laboratory Accreditation / Education / CME
May 2015: Computer Software and Systems
June 2015: Diagnostic Testing / Reagents

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