Companion Diagnostic definition
Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:
Companion Diagnostic means any product that is used for predicting and/or monitoring the response of a human being to treatment with a Product (e.g. device, compound, kit, biomarker or service that contains a component that is used to detect or quantify the presence or amount of an analyte in body or tissue that affects the pathogens of the disease).
Companion Diagnostic means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy;
Examples of Companion Diagnostic in a sentence
In addition, such provision does not prevent Janssen or any of its Affiliates from directly or indirectly contracting with Third Parties to design, develop, manufacture, seek regulatory approval from regulators outside the Territory, and commercialize a NGS cfDNA Companion Diagnostic outside the Territory, during the Exclusivity Period.
The Parties acknowledge and agree that ▇▇▇▇▇▇▇ may seek to work with Third Parties for the development of a NGS cfDNA Companion Diagnostic for the administration of the ▇▇▇▇▇▇▇ Drug as a treatment for the Indication within the Territory, during the Exclusivity Period.
More Definitions of Companion Diagnostic
Companion Diagnostic means any product or service that:
Companion Diagnostic means any companion diagnostic tool and/or diagnostic assay, the manufacture, use, sale or importation of which is Covered by the Company Crispr/Cas Technology, Company Optimized Cas Technology, CRISPR Background Know-How and CRISPR Platform Technology Know-How, which is used to (i) […***…], (ii) […***…], and/or (iii) […***…].
Companion Diagnostic. Companion Diagnostic means an IVD that provides information regarding the identification of patients for treatment with a corresponding therapeutic product, including where such use may be specified in the instructions for use in the labeling of both the IVD device and the corresponding therapeutic product in relevant jurisdictions.
Companion Diagnostic means a biomarker or diagnostic test that is developed by or on behalf of a Party or jointly by the Parties in the course of the Collaboration as a companion diagnostic for use with a Shared Product in accordance with the Regulatory Approval(s) therefor to generate a result for the purposes of diagnosing a disease or condition, or to facilitate the application of any Shared Product in the cure, mitigation, treatment, or prevention of disease, including a biomarker or diagnostic test used to diagnose the likelihood that a specific patient will contract a certain disease or condition or to predict which patients are suitable candidates for a specific form of therapy using a Shared Product.
Companion Diagnostic means any product or service that: [***].
Companion Diagnostic means a product (a) for the identification of a patient’s suitability for treatment with a Product; (b) for uses connected with the prognosis of a patient with prostatic disease who is treated with a Product; or (c) to monitor the biologic effect or response of the patient to the Product.
Companion Diagnostic means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy; (6) ‘companion diagnostic’ means a device specifically intended for and essential to the selection of patients with a previously diagnosed condition or predisposition as suitable or unsuitable for a specific therapy with a medicinal product or a range of medicinal products;