Central Laboratory Services. Anatomic Pathology Histology Services

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1 Central Laboratory Services Anatomic Pathology Histology Services

2 Oncology and Beyond... There is no question that innovations in technology have the potential to significantly impact a number of clinical applications. But technology alone can never fully actualize its potential. That is, until you look beyond. It is not until advanced technologies are placed in the skillful hands of an experienced team of experts experts in science, in process, in medicine, and logistics that we will fully realize the value of these advances. In response to the evolving needs of the industry consistency, specimen integrity, and efficiency we challenged ourselves to look beyond and deliver. ] Collection & Processing Uniform sample collection kits To reduce errors and increase global consistency Superior logistics solutions To mitigate risk of lost or damaged samples In-house tissue processing For sample integrity Tissue Processing Services QUALITY AND CONSISTENCY BEGINS... AT THE BEGINNING! Our dedication to consistency is evident from the very beginning. Combining extensive automation with manual customization capabilities, our automated kit production facility delivers globally uniform specimen collection kits to assure consistent collection across all sites. Consistency Assuring quality trial data Standardized biopsy collection kits for consistent site-to-site specimen collection Strict adherence by experienced in-house histotechnologists to SOPs for gross description Special handling for specimens that will undergo immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), or nucleic acid preparation Specimen Integrity Protecting your valuable assets Data records follow each specimen for a meticulous audit trail Reduced exposure to excess fixatives

3 Staining & Assays Automated staining [ ] For superior consistency Tissue biomarker expertise Network of referral labs Complete global solutions Human breast tissue immunohistochemically stained to demonstrate estrogen receptor production. Histochemical Staining Services CONSISTENCY DOWN TO A SCIENCE LITERALLY. Our in-house automated stainers are capable of performing a wide range of stains, including routine H&E staining along with a variety of special stains. Automation of frequently performed staining delivers the utmost efficiency and consistency. For lower volume staining tasks, our highly trained histotechnologists follow strict manual staining SOPs to deliver consistent results while maintaining efficiency for your studies. Genomics & Biomarker Assays THE FINE ART OF TISSUE SCIENCE. The answers are in the detail. And our attention to detail is exacting! From precise interpretation to on-time delivery to real-time flexibility, we offer solutions to meet the precise standards of your trial. Tissue biomarker assays Extensive options for customized solutions: We utilize a global network of referral and in-house laboratories to provide the most efficient solution for your IHC or FISH assays. For rapid turn-around times, we work with several laboratories in the US that provide access to a comprehensive menu of biomarkers. Diverse pharmacogenomics capabilities Genomics solutions you can depend on: We combine the capabilities of our in-house laboratories at Covance CLS sites and our Seattlebased Covance Genomics Laboratory, as well as specialized referral laboratories to deliver a complete genomics solution. Global pathologist expertise Specialists you can trust: Tissue biomarker specialist interpretations are provided via our network of referral lab pathologists to provide the right specialist for your study, or we can utilize a pathologist of your choosing. Either way, you will get the right expert to provide accuracy and consistency.

4 Digital Pathology Services Digital Pathology Services Digital slide scanning for archival image storage Copies of images available on media In-house target lesion tissue identification by Covance CLS pathologists Target lesion percent and area determination Remote access to specimen images Target lesion macrodissection for enrichment TAKING TECHNOLOGY AND MAKING IT BETTER. Often, the most powerful innovation is the process that supports the technology. Covance looked beyond to imagine how to deploy the power of digital pathology to better meet the needs of your unique trials. Specimen Security and Integrity. Your Covance Digital Pathology Services team can deliver the same high-quality results from patients next door or around the globe. Science and operations work together to anticipate and respond to the rigors of managing your delicate pathology samples. Specimen handling in a single location, including tissue processing, staining, target feature identification, and even storage, reduces the risk of loss or damage and protects your valuable assets. [ Analysis In-house target identification Rapid decisions Specialist interpretation via referral laboratory network Options for sponsorchosen pathologists Exceptional Data Consistency. All specimens are reviewed by a consistent team of pathologists working together under the same exacting standards. Additionally, remote access to slide images can be available for secure and efficient review by your pathologists. Greater Accuracy. The deployment of advanced technologies delivers greater consistency and results in faster trial enrollment decisions. Reduced shipment of slides helps to mitigate risk of loss or damage and eliminates costly handling steps and long turn around times. Customized Solutions for Greater Flexibility. Our team of experts is dedicated to providing exceptional services from the simplest to the most complex laboratory services. We create customized solutions for every trial, based on tissue and tumor type, staining requirements, and the need for customized assays. Digital image of a human tissue marked to guide macrodissection Aperio s ScanScope system consistently delivers digital slides with superior image quality.

5 [ Specimen Allocation Stringent SOPs For consistent results Nuclease-free services available To guard against crosscontamination FFPE DNA/RNA isolation To meet specific study requirements Automated kit production facility assures consistent tissue collection for quality trial data. ] Embedding and Sectioning Services SAME ADVANCED EQUIPMENT. SAME EXACTING STANDARDS. We can t overemphasize the need for consistency. That s why we deploy the same advanced technologies according to the same exacting procedures regardless of where your specimens are processed, producing highly combinable results. Within this framework of consistency, we are also able to offer a host of options: Routine and nuclease-free services Special handling of samples for genomics testing to eliminate contamination or degradation Variety of nucleic acid purification services, including formalin-fixed, paraffin-embedded (FFPE) DNA/RNA extraction Sectioning of paraffin-embedded tissues or cell blocks using microtomes Standard or customized thickness, depending on your protocol Sections mounted on slides or captured in microcentrifuge tubes for downstream processing Standard or positively charged glass slides and polyethylene naphthalate (PEN) slides for laser capture microdissection Standard and nuclease-free microcentrifuge tubes Tissue sectioned on a microtome standardized processes assure consistent quality.

6 Specimen Management YOUR SPECIMENS ARE AMONG YOUR MOST VALUED ASSETS. Covance looks beyond the slide and understands it represents much more a clinical trial that could deliver life-saving therapies to the patients represented by that single slide. We are committed to guarding these precious assets at every stage. Storage Specimen tracking via LabLink+ To protect specimens Advanced biorepository For specimen integrity over time Now it s your turn to look beyond. Look beyond and imagine other services you might need whether that is unstained slides or customized services provided either in-house or through our network of specialty laboratories. Our goal is to work as partners for the advancement of critically needed pharmaceutical and biotechnical therapies for patients around the globe. Processing To meet your specific study requirements To manage embedded tissue blocks and slides, Covance offers: Pathology report imaging Block ID confirmation Anatomic site and sample integrity verification Storage Ensuring sample integrity whenever your specimens are needed An equally important step in the process is the storage of your irreplaceable specimens for continued sample integrity. With over 20 years of experience, we utilize sophisticated biorepository systems to store your samples under extreme conditions, ranging from ambient temperature to -150º C. Logistics Mitigating the risk of loss or damage Slides and tissue/cell blocks bar-coded for reliable identification and tracking Logistics management of shipments between storage facilities, investigator sites, and referral laboratories Specimens and results tracked and managed using our LabLink+ application Covance is an independent, publicly held company with headquarters in Princeton, New Jersey, USA. Covance is the marketing name for Covance Inc. and its subsidiaries around the world. THE AMERICAS COVANCE ( ) EUROPE/AFRICA ASIA PACIFIC Copyright 2012, Covance Inc. BROCLSO Central Laboratory Services