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

• Transgene Signs an Agreement with Xxxxxxx Xxxxxxx for the Development of a Companion Diagnostic Test for TG4010 The agreement completes Transgene■s biomarker strategy for the development of TG4010 in Phase IIb/III clinical trials Parc d■Innovation, Illkirch (France), January 5, 2011 ■ Transgene (NYSE-Euronext: TNG) announced today that the company has signed an agreement with Xxxxxxx Xxxxxxx, Inc.

• The Parties shall discuss and attempt to agree whether to recall or withdraw the Companion Diagnostic; provided, however, the final decision as to whether to recall or withdraw the Companion Diagnostic commercialized by Genoptix and the procedures therefor shall be made solely by Genoptix.

• Ambit shall be responsible for all Companion Diagnostic Expenses.

• The Parties have agreed upon an initial Companion Diagnostic Activities budget of […***…] for the estimated period of […***…] beginning in January 2010; such budget is attached hereto as Exhibit A.

• For clarification, Genoptix Marks shall exclude any trademark of Genoptix (a) that was in use by Genoptix prior to the Effective Date or (b) that is or has been used in connection with the commercialization of any Genoptix product other than the Companion Diagnostic.

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 companion or complementary diagnostic products to be used in connection with Licensed Products.

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 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.

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. 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.