Invivoscribe product catalogue 2017 | 143 Invivoscribe 2019 | 143 Custom Products 142 Customized Products to Meet Your Needs The Invivoscribe team of experts can help develop your ideas into customized products. Allow us to partner with you to take a basic concept through design, development, validation, regulatory approval (if applicable), and release. For more information, please call our San Diego office at +1 858.224.6600 or send an e-mail to sales@invivoscribe.com. Custom Designed Assays In response to the FDA announcing its intention to dramatically expand its regulatory oversight of laboratory developed tests (LDTs), Invivoscribe is partnering with laboratories worldwide to help facilitate the conversion of LDTs into FDA-cleared assays, as we know the barriers to bringing new assays online are often the availability of resources and the cost of validation. By leveraging the power of our regulatory expertise, provided through each milestone, we can help ensure safety, efficacy and quality. Our customizable reagent manufacturing capabilities can reduce your LDT costs and lead to higher-quality testing. To date, we have partnered with more than 40 laboratories around the world to develop, validate, and launch a variety of molecular products. A number of these partnerships have also led to the release of US and CE-marked in vitro diagnostic products and services. Learn how Invivoscribe can help you develop assays for new products, services, and novel applications. Custom Controls and Validation Panels We offer a large selection of well-characterized DNA and RNA controls that are used to define the performance characteristics of a wide variety of molecular reagents. To address your specific requirements, we can partner with you to design, validate, and provide custom controls and validation panels. If necessary, we are willing to acquire, characterize, and engineer custom controls for your specific application. We can produce DNA, RNA, or cDNA at any specified concentration, dilution, or volume. Please contact us with your requirements and we will be happy to provide controls to suit your needs. Invivoscribe is a Comprehensive Partner for Companion Diagnostic Development From biomarker identification through commercialization, Invivoscribe has expertise at every stage of companion diagnostics development. •  Discovery & Patient Stratification: We offer comprehensive gene panels to identify biomarkers and define patient populations, thus reducing development costs and improving the success of clinical trials. •  Clinical Trials: Our network of global laboratories accelerates sample acquisition and harmonizes testing to ensure accurate results. •  Regulatory Approval: Our in-house experts have experience seeking approval with global agencies. • Commercialization: Our cGMP manufacturing expertise and distribution channels allow approved CDx to reach all global markets. Invivoscribe is an ISO 13485-accredited and FDA/CDRH registered medical device manufacturer with a long record of successful partnerships. We are the industry-leading assay and software development company, providing full QSR design control and a complete range of cGMP manufactured assays, controls, reagents, and services to CLIA-accredited clinical laboratory and pharmaceutical communities. Please contact us at +1 858.224.6600 or sales@invivoscribe.com for more details about partnering with Invivoscribe for the development and manufacturing of companion diagnostics, in vitro diagnostics, molecular reagents, and/or nucleic acid controls. Custom Products Warranty and Liability Invivoscribe, Inc. (Invivoscribe® ) is committed to providing the highest quality products. Invivoscribe® warrants that the products meet or exceed the performance standards described in the Instructions For Use, as to products with such an insert. If a product is covered by product specifications and does not perform as specified, our policy is to replace the product or credit the full purchase price. No other warranties of any kind, expressed or implied, are provided by Invivoscribe® . Invivoscribe® liability shall not exceed the purchase price of the product. Invivoscribe shall have no liability for direct, indirect, consequential, or incidental damages arising from the use, results of use, or inability to use its products; product efficacy under purchaser controlled conditions in purchaser’s laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative, and blank controls every time a sample is tested. Ordering, acceptance, and use of product constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement to the limitation of liability set forth in this paragraph. Custom Products