Cologuard definition

Cologuard non-invasive colon cancer screening in-vitro diagnostic test kit developed by EXACT and approved by the U.S. Food and Drug Administration on August 11, 2014, including any Update, Improvement or Replacement of Cologuard.
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Cologuard means Cologuard®, a non-invasive, stool-based DNA screening test that utilizes a multi-target approach to detect DNA and hemoglobin biomarkers associated with colorectal cancer and pre-cancer.
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Cologuard. The definition of “Cologuard” in Section 1.03 is amended to read as follows:
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Examples of Cologuard in a sentence

  • One (1) Cologuard (FIT-fecal) DNA Testing (1 per Benefit Period for ages 45-75) 3.

  • The Company’s revenue is primarily generated by its laboratory testing services utilizing its Cologuard, Oncotype DX, and COVID-19 tests.

  • Colorectal Cancer Screening – FIT (fecal immunochemical test for blood), Cologuard (FIT-fecal) DNA testing, Computed Tomographic (CT) colonography, flexible sigmoidoscopy, or routine colonoscopy provided in accordance with the most recently published recommendations established by the American College of Gastroenterology, in Consultation with the American Cancer Society, for the ages, family histories and frequencies referenced in such recommendations.

  • Colorectal Cancer Screening – a FIT (Fecal Immunochemical Test for blood), Cologuard (FIT-fecal) DNA testing, Computed Tomographic (CT) colonography, flexible sigmoidoscopy, or routine colonoscopy provided in accordance with the most recently published recommendations established by the American College of Gastroenterology, in Consultation with the American Cancer Society, for the ages, family histories and frequencies referenced in such recommendations.

  • The results of our DeeP-C clinical trial for Cologuard were published in the New England Journal of Medicine in April 2014.

  • On August 11, 2014 the U.S. Food and Drug Administration (“FDA”) approved Cologuard for use as the first and only sDNA non-invasive colorectal cancer screening test.

  • Our submission to the FDA for Cologuard included the results of our pivotal DeeP-C clinical trial that had over 10,000 patients enrolled at 90 sites in the U.S. and Canada.

  • Our contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the delivery of a patient’s Cologuard test result to the ordering physician.

  • Reimbursement may also be affected by whether Cologuard is in-network for a given payer.

  • It should also be noted that light meter readings were taken on the date of inspection that measured well below the requirement for this Ohio jail standard.

Related to Cologuard

  • coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Cosmetology means any one and/or combination of practices generally and usually performed by and known as the occupation of beauty culturalist, cosmeticians, cosmetologists or hairdressers or any person holding him or herself out as practicing cosmetology in or upon a place or premises. Cosmetology shall include, but otherwise not be limited to, the following: embellishing, arranging, dressing, curling, waving, cleansing, beautifying, cutting, singeing, bleaching, coloring, or similar work upon the hair of any person by any means and with hands or mechanical or electrical apparatuses, devices or appliances or by use of cosmetic preparations, antiseptics, tonics, lotions, creams or otherwise, massaging, cleansing, stimulating, manipulating, exercising, beautifying or similar work, the scalp, face, neck, arms, hands, bust or upper part of the body, or manicuring, pedicuring or sculpting the nails of any person.

  • LHSIA means the Local Health System Integration Act, 2006, and the regulations made under it, as it and they may be amended from time to time;

  • Automotive windshield washer fluid means any liquid designed for use in a motor vehicle windshield washer system either as an antifreeze or for the purpose of cleaning, washing, or wetting the windshield. Automotive windshield washer fluid does not include fluids placed by the manufacturer in a new vehicle.

  • Halogen means one of the chemical elements chlorine, bromine or iodine.

  • Pyrolysis means the thermal degradation of a substance in the absence of any oxidising agent, which does not form part of the substance itself, to produce char and gas and/or liquid; and

  • cannabis resin means the separated resin, whether crude or purified, obtained from any plant of the genus Cannabis;

  • Cosmetologist means an individual licensed under this chapter to practice cosmetology.

  • Gonad shield means a protective barrier for the testes or ovaries.

  • Crawling bug insecticide means any insecticide product that is designed for use against ants, cockroaches, or other household crawling arthropods, including, but not limited to, mites, silverfish or spiders. “Crawling Bug Insecticide” does not include products designed to be used exclusively on humans or animals, or any house dust mite product. For the purposes of this definition only:

  • Cannabidiol means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0.90 percent tetrahydrocannabinol by volume that has been extracted from marijuana or synthesized in a laboratory.

  • Pretreatment coating means a coating which contains no more than 12% solids by weight, and at least 0.5% acid by weight, is used to provide surface etching, and is applied directly to metal surfaces to provide corrosion resistance, adhesion, and ease of stripping.

  • Disposable respirator means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

  • Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

  • Medical marijuana waste or "waste" means unused,

  • aeroplane means a power-driven heavier-than-air aircraft, deriving its lift in flight chiefly from aerodynamic reactions on surfaces which remain fixed under given conditions of flight;

  • Oxides of nitrogen means the sum of the volume mixing ratio (ppbv) of nitrogen monoxide (nitric oxide) and nitrogen dioxide expressed in units of mass concentration of nitrogen dioxide (µg/m3);

  • Flea and tick insecticide means any insecticide product that is designed for use against fleas, ticks, their larvae, or their eggs. “Flea and Tick Insecticide” does not include products that are designed to be used exclusively on humans or animals and their bedding.

  • Cannabis waste means waste that is not hazardous waste, as defined in Public Resources Code section 40141, that contains cannabis and that has been made unusable and unrecognizable in the manner prescribed in sections 5054 and 5055 of this division.

  • Riprap means small, broken stones or boulders placed compactly or irregularly on dykes or similar embankments for protection of earth surfaces against wave action or current;

  • Cannabis means all parts of the plant Cannabis sativa Linnaeus, Cannabis indica, or Cannabis ruderalis, whether growing or not; the seeds thereof; the resin, whether crude or purified, extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin. “Cannabis” also means the separated resin, whether crude or purified, obtained from cannabis. “Cannabis” does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination. For the purpose of this division, “cannabis” does not mean “industrial hemp” as defined by Section 11018.5 of the Health and Safety Code. Cannabis and the term “marijuana” may be used interchangeably.

  • Anesthesiologist means a physician granted clinical privileges to administer anesthesia.

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Laser means any device excepting a Class 1 device which can be made to produce or amplify electromagnetic radiation in the wave length range from 100 nanometres to 1 millimetre primarily by the process of controlled stimulated emission.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.