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 any product or service that:

Examples of Companion Diagnostic in a sentence

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

• 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”).

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

• Within thirty (30) days after the Effective Date, the Parties shall establish a Joint Companion Diagnostic Committee (the “JCDC”) to plan, direct, manage and coordinate all aspects of the Parties’ activities under this Agreement during the Regulatory Phase.

• Each Party shall perform the Companion Diagnostic Activities for which it is responsible in good scientific manner and in compliance with all applicable Laws.

More Definitions of Companion Diagnostic

Companion Diagnostic means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy;

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 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, with respect to a Product, (a) a companion diagnostic approved by the applicable Regulatory Authority that provides information essential to the safe and effective use of such Product or is otherwise necessary for the Regulatory Approval of such Product, or (b) a complementary diagnostic that provides information helpful to the safe and effective use of such Product but is not a companion diagnostic referred to in the foregoing clause (a).

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 laboratory developed test that uses the Assay and is intended to be marketed as an FDA-approved test (subject to FDA approval) to assist healthcare professionals in making treatment decisions for their AML patients based on the presence (“ITD-Positive”), or absence (“ITD-Negative”), of the internal tandem duplication (“ITD”) mutation in the FLT3 sequence of such patient. For clarification, “Companion Diagnostic” shall exclude any test described in Section 4.4.

Companion Diagnostic means a biomarker or diagnostic test that may be used with a Licensed Product, or may be developed by the Parties pursuant to Section 3.4, to generate a result for the purposes of diagnosing a disease or condition, or to facilitate the application of the Licensed Product that is used 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 type of cancer or to predict which patients are suitable candidates for a specific form of chemotherapy.