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

• List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools).

• Statistical Methods for Clinical Validation of Follow-On Companion Diagnostic Devices via an External Concordance Study.

• The development of Licensed Product shall be governed by a written multi-year, research and development plan that sets forth the anticipated research, pre-clinical and clinical development activities to be performed with respect to such Licensed Product (and, if relevant, any Companion Diagnostic) throughout the Territory, and projected timelines for completion of such activities (the “Development Plan”).

• If PMA Approval is obtained and Genoptix (itself or through its Affiliates or licensees) elects to commercialize the Companion Diagnostic […***…].

• FoundationOne CDx Companion Diagnostic Biomarkers and Claims 16 Figure 9.

More Definitions of Companion Diagnostic

Companion Diagnostic means any product or service that:

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 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 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 Licensed Product in accordance with the Regulatory Approval(s) therefor to generate a result for the purpose of diagnosing a disease or condition, or to facilitate the application of any Licensed 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 Licensed Product.

Companion Diagnostic means any product or service that: [***].

Companion Diagnostic means an in vitro diagnostic device consisting of or containing Licensed Antibody(ies) that provides information for the safe and effective use of a particular therapeutic Product, where the use of such in vitro diagnostic device is stipulated in the instructions for use in the labeling of both such in vitro diagnostic device and the corresponding therapeutic Product approved by the applicable Regulatory Authority.

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.