Guardant Health Icd 10 Requirements

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Article - Billing and Coding: Guardant360® (A58214)

(Just Now) WebArticle Guidance. Coverage will continue on a case by case basis utilizing the following criteria until such time a more comprehensive non-proprietary local coverage determination can be developed. Guardant360® remains covered for patients with non …

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58214

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2023 Annual Notice to Physicians - GuardantHealth

(Just Now) WebLCDs and NCDs have sections describing what medical conditions are covered and the ICD-10 codes that are covered. All clinical orders sent to Guardant Health must include …

https://guardanthealth.com/annualnotice/

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Guardant_Shield_FactSheet (3).pdf - Home - GuardantHealth

(7 days ago) WebThe Shield blood test* uses a multimodal approach, integrating genomics, epigenomics and proteomics, to achieve high sensitivity and specificity in detecting early signs of …

https://guardanthealth.com/wp-content/uploads/Guardant_Shield_FactSheet-1.pdf

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Q&A with Guardant Health about Blood Tests for CRC Screening

(4 days ago) WebOnce Shield is approved by the FDA, however, it will be the first FDA-approved blood-based colorectal cancer screening test that meets the requirements for …

https://coloncancercoalition.org/2024/03/14/qa-with-guardant-health-about-blood-tests-for-crc-screening/

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LBL-000042 R5 Guardant360 CDx Technical Information, US

(8 days ago) Webthe Guardant Health Client Services department (Tel: 855.698.8887, Fax: 888.974.4258, or Email: [email protected]). 5.3. Principles of the Procedure …

https://www.guardantcomplete.com/assets/pdf/Guardant360-CDx-Technical-Information-US.pdf

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Guardant360®: Comprehensive Liquid Biopsy Test - Guardant …

(3 days ago) WebPatients. Blood-Based Screening. Annual Physician Notice. Advance Beneficiary Notice. Technical Information. Physician Insert. Guardant360® liquid biopsy test assesses an …

https://www.guardantcomplete.com/products/guardant360

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Guardant Health - Specification Sheet

(2 days ago) WebMicrosatellite Instability (MSI-High) Guardant360 CDx was highly concordant with tissue and improved alteration detection amongst patients with advanced NSCLC1. Concordance …

https://guardanthealth.eu/wp-content/uploads/2021/01/Guardant360-CDx-Specification-Sheet.pdf

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Physician ®Insert: Guardant360 CDx - Guardant Complete

(3 days ago) WebThis tube has been designed to fill with 10 mL of blood. LBL-000043 R4 3 Limitations For in vitro diagnostic use. For prescription use only. This test must be ordered by a qualified …

https://www.guardantcomplete.com/assets/pdf/Guardant360-CDx-Physician-Insert-US.pdf

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p r e c i s i o n o n c o l o g y t o m o r e ad v an c e d c an c e r

(7 days ago) WebIn 2014, we introduced the Guardant360 test for advanced cancer patients. It was the first-in-kind liquid biopsy to comprehensively sequence a patient's cancer to reveal actionable …

https://guardanthealth.com/wp-content/uploads/Guardant360_CDx_Backgrounder_Document.pdf

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Guardant360 - Clinical test - NIH Genetic Testing Registry (GTR)

(7 days ago) WebThere may be a URL to the laboratory's webpage with information about specimen requirements for this test. This section may also have a URL for the …

https://www.ncbi.nlm.nih.gov/gtr/tests/527948/howtoorder/

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G360 Specification Sheet - Guardant Health

(3 days ago) WebGuardant360 provides guideline-recommended genomic results in 7 days from a routine blood draw, eliminating the need to solely rely on tissue testing. Guardant360 also …

https://guardanthealth.eu/wp-content/uploads/2021/01/G360-Specification-Sheet-1.pdf

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Tests for Patients with Early and Advanced Stage Cancer

(2 days ago) WebGuardant Reveal is a completely tissue-free test that detects circulating tumor DNA (ctDNA) for minimal residual disease (MRD) assessment in early-stage colorectal, breast, and …

https://guardanthealth.com/products/tests-for-patients-with-early-and-advanced-stage-cancer/

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Guardant Health, Inc. - Guardant Health Receives ADLT Status …

(8 days ago) WebGuardant Health, Inc. (Nasdaq: GH) announced that the Centers for Medicare Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test …

https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant-Health-Receives-ADLT-Status-from-CMS-for-FDA-Approved-Guardant360-CDx-Test/default.aspx

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Guardant 360 - Marshfield Labs

(4 days ago) WebCollect sample by venipuncture, completely filling the two 10.0 mL blood collection tubes provided in the Guardant 360 kit. Mix by gentle inversion 10 times. *DO NOT …

https://www.marshfieldlabs.org/sites/ltrm/Human/Pages/26371.aspx

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CDx - Food and Drug Administration

(9 days ago) WebGuardant Health, Inc. must provide data from a guardbanding study to test the tolerance of Guardant360 CDx to variation in critical parameters, i.e., cell-free DNA …

https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200010A.pdf

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Tests for Cancer Screening - GuardantHealth

(3 days ago) WebThis test has demonstrated to be accurate at detecting colorectal cancer by identifying circulating tumor DNA (ctDNA) in the blood. 20. Our ECLIPSE study validates Shield™ …

https://guardanthealth.com/products/tests-for-cancer-screening/

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Guardant360 Response - Clinical test - NIH Genetic Testing …

(7 days ago) WebThere may be a URL to the laboratory's webpage with information about specimen requirements for this test. This section may also have a URL for the …

https://www.ncbi.nlm.nih.gov/gtr/tests/593444/howtoorder/

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Guardant Health Receives Medicare Coverage for - Business Wire

(5 days ago) WebGuardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY™ …

https://www.businesswire.com/news/home/20230418005635/en/Guardant-Health-Receives-Medicare-Coverage-for-Guardant360-Response%E2%84%A2-to-Monitor-Cancer-Patient-Response-to-Immunotherapy

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FDA Executive Summary - U.S. Food and Drug Administration

(1 days ago) WebFDA Executive Summary: Guardant Health Inc., Shield Page 7 of 27 . colonoscopy years • Normal colonoscopy • s20HP<10mm 7-10 years • 1-2 adenomas …

https://www.fda.gov/media/178792/download

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GH - Guardant Health Receives EU IVDR Certification for

(5 days ago) WebGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s …

https://marketwirenews.com/news-releases/guardant-health-receives-eu-ivdr-certification-for-g-5415330824078335.html

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Guardant Reveal - Clinical test - NIH Genetic Testing Registry …

(7 days ago) WebThere may be a URL to the laboratory's webpage with information about specimen requirements for this test. This section may also have a URL for the …

https://www.ncbi.nlm.nih.gov/gtr/tests/593766/howtoorder/

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How To Use CPT Code 0326U - Coding Ahead

(3 days ago) WebCPT 0326U can be used to describe a specific laboratory test called Guardant360® from Guardant Health Inc. This test utilizes next-generation sequencing (NGS) targeted …

https://www.codingahead.com/cpt-code-0326u/

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CPT ® 0242U, Under Proprietary Laboratory Analyses - AAPC

(2 days ago) WebSummary. This is a Proprietary Laboratory Analyses (PLA) code, meaning that the code applies to only one unique lab test made by a specific manufacturer or performed by a …

https://www.aapc.com/codes/cpt-codes/0242U

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