b'Custom ProductsCustomized Products to Meet Your NeedsRegulatory Approval: Our in-house experts have experience seeking approval with global agencies.The Invivoscribe team of experts can help develop your ideas into customized products. Allow us to partner with you to take a basicCommercialization: Our cGMP manufacturing expertise and concept through design, development, validation, regulatory approvaldistribution channels allow approved CDx to reach all(if applicable), and release. For more information, please call our global markets.San Diego office at +1 858.224.6600 or send an e-mail to Invivoscribe is an ISO 13485-accredited and FDA/CDRH registered sales@invivoscribe.com. 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 Custom Designed Assays a complete range of cGMP manufactured assays, controls, In response to the FDA announcing its intention to dramaticallyreagents, and services to CLIA-accredited clinical laboratory and expand its regulatory oversight of laboratory developed tests (LDTs),pharmaceutical communities.Invivoscribe is partnering with laboratories worldwide to help facilitate the conversion of LDTs into FDA-cleared assays, as we know the Custom Products barriers to bringing new assays online are often the availability ofPlease contact us at +1 858.224.6600 or sales@invivoscribe.comresources and the cost of validation. for more details about partnering with Invivoscribe for the developmentand manufacturing of companion diagnostics, in vitro By leveraging the power of our regulatory expertise, provided throughdiagnostics, molecular reagents, and/or nucleic acid controls.each milestone, we can help ensure safety, efficacy and quality.Our customizable reagent manufacturing capabilities can reduceyour 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 newproducts, services, and novel applications.Custom Controls and Validation PanelsWe 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 DevelopmentFrom biomarker identification through commercialization, Invivoscribe has expertise at every stage of companion diagnostics development.WARRANTY AND LIABILITY Discovery & Patient Stratification: We offer comprehensive genepanels to identify biomarkers and define patient populations, Invivoscribe, Inc. (Invivoscribe) is committed to providing the highest quality products. Invivoscribe warrants that the products meet or exceed the performance standards described in thethus reducing development costs and improving the success of 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. Invivoscribeclinical trials.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 controlledClinical Trials: Our network of global laboratories acceleratesconditions in purchasers laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative,sample acquisition and harmonizes testing to ensureand 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. accurate results.Invivoscribe productIn cvivatoscribe 2021alogue 2017|147|147'