Clinical Diagnostics definition

Clinical Diagnostics means all testing to detect, identify, and/or quantitate one or more nucleic acid sequences for the purposes of detecting, diagnosing, making prognoses, monitoring, treating, preventing, or studying Human Disease. As used herein, “Human Disease” means any aberration of structure or function of any human cell, tissue or organ, living or dead. Without limiting the generality of the foregoing, Clinical Diagnostics includes testing in human clinical trials.
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Clinical Diagnostics means the performance of FDA-approved clinical diagnostic test(s) on a human tissue or other human biological sample, the results of which are provided to health care providers for use in the clinical management of individual patients.
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Clinical Diagnostics means, in the clinical medical practice, the assaying, testing or determination of, inside or outside of a living human or animal, one or more biomarkers in or on any test sample for the purpose of identifying, characterizing, defining or diagnosing a disease state (including, without limitation, determining the state of health of a human or animal) to identify, treat or prevent disease, as well as the screening, prognosis, therapeutic monitoring and/or evaluation of the progression of any disease. For the avoidance of doubt, if an assay is being performed on a living animal, or on animal tissue or other sample derived from a living animal, for the purpose of food testing, such application shall not be considered a Clinical Diagnostic.
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Examples of Clinical Diagnostics in a sentence

  • The Clinical Diagnostics segment develops, manufactures, sells and services automated test systems, informatics systems, test kits and specialized quality controls for the healthcare market.

  • We have two reportable segments: Life Science and Clinical Diagnostics.

  • Bio-Rad has two reportable segments: Life Science and Clinical Diagnostics.

  • This segment has five primary businesses: Clinical Diagnostics, ImmunoDiagnostics, Microbiology, Transplant Diagnostics and Healthcare Market Channel.

  • Since the Panther Instrument was designed for use in Clinical Diagnostics and not for use in the Roka Field, Gen-Probe intends to keep track of warranty claims made on the Panther Instruments used in the Roka Field (the “Roka Warranty Claims”) as compared to warranty claims made on the Panther Instruments used for Clinical Diagnostics (the “Non-Roka Warranty Claims”).

  • On the terms of the Agreement and this Panther Addendum, Gen-Probe will combine its own forecasts and orders for Panther Instruments for use in the Clinical Diagnostics Field with Novartis’ orders for Panther Instruments in the Blood Screening Field.

  • Clinical Diagnostics sales growth should be in the 8 to 10% range.

  • The three business groups (Clinical Diagnostics, Labware and Life Sciences, and Laboratory Equipment) have been reclassified into two business segments: Clinical Group and Research Group.

  • On December 22, 2021, the Company entered into a Business Combination Agreement (the “BCA”) by and among the Company, Ortho Clinical Diagnostics Holdings plc (“Ortho”), Quidel Corporation (“Quidel”) and certain other parties, which provides for the acquisition of Quidel and Ortho by the Company (the “Transaction”).

  • Until recently there have not been any in vitro diagnostic quality assays available to replace the lumbar puncture diagnostic procedure and there may not be until Saladax / Ortho Clinical Diagnostics or Roche Diagnostics release their publically report CSF Ab42 and CSF Tau assays.Positron Emission Tomography (PET)PET requires large, multi-million dollar cameras which collect the radioactive decay of minute quantities of hot radioactive tracers injected into the blood stream.


More Definitions of Clinical Diagnostics

Clinical Diagnostics. ("cDx"): shall mean test(s) performed on a human tissue or other human biological sample, the results of which are provided to payors, providers, or patients for use in the clinical management of individual patients, which become part of such patient's health record; provided, however, that Clinical Diagnostics shall expressly exclude test(s) performed on human tissue or other human biological sample in the course of Phase I, II, III or IV clinical trials for an ethical pharmaceutical.
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Clinical Diagnostics shall have the meaning set forth in the Cross License Agreement of even date herewith between the parties.
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Related to Clinical Diagnostics

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Diagnostic Services means services provided for the purpose of determining the nature and cause of a condition, ill- ness, or injury.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Novartis shall have the meaning set forth in the Preamble.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.