Foundation One Security Medical

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FoundationOne CDx | Foundation Medicine

https://www.foundationmedicine.com/test/foundationone-cdx

FoundationOne CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx) that is clinically and analytically validated for all solid tumors. The test is designed …

Billing and Reimbursement | Foundation Medicine

https://www.foundationmedicine.com/resource/billing-and-financial-assistance

Some commercial health plans such as Cigna and many BlueCross BlueShield plans offer coverage for Foundation Medicine testing services. Medicare covers …

FoundationOne Liquid CDx – P190032 | FDA

https://www.fda.gov/medical-devices/recently-approved-devices/foundationone-liquid-cdx-p190032

The FoundationOne Liquid CDx is a lab test that detects specific gene mutations found in circulating cell-free DNA (cfDNA) isolated from whole blood plasma …

Licenses | Foundation Medicine

https://www.foundationmedicine.com/resource/licenses

All Foundation Medicine comprehensive genomic profiling tests are CAP Accredited, CLIA Certified, and New York State Department of Health (NYSDOH) Approved. View our …

FoundationOne CDx – P170019/S029 | FDA

https://www.fda.gov/medical-devices/recently-approved-devices/foundationone-cdx-p170019s029

FoundationOne CDx is a companion diagnostic, or test used to help match a patient to a specific drug or therapy. It was originally approved to find genetic mutations …

FoundationOne® CDx - P170019/S017 | FDA

https://www.fda.gov/medical-devices/recently-approved-devices/foundationoner-cdx-p170019s017

Product Name: FoundationOne®CDx (F1CDx) PMA Applicant: Foundation Medicine, Inc. Address: 150 Second Street, Cambridge, MA 02141 Approval Date: …

FDA Approves Blood Tests That Can Help Guide Cancer …

https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-guardant-360-foundation-one-cancer-liquid-biopsy

The Food and Drug Administration (FDA) has approved two blood tests, known as liquid biopsies, that can help guide treatment decisions for people with cancer. …

U.S. FDA Approves FoundationOne®CDx as a …

https://www.businesswire.com/news/home/20220221005179/en/U.S.-FDA-Approves-FoundationOne%C2%AECDx-as-a-Companion-Diagnostic-for-KEYTRUDA%C2%AE-pembrolizumab-to-Identify-Patients-with-Microsatellite-Instability-High-MSI-H-Solid-Tumors

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), …

Foundation Medicine Expands Indication for …

https://www.foundationmedicine.com/press-releases/a9f8e620-9997-43e1-a5c9-94c79616f07f

Foundation Medicine Expands Indication for FoundationOne®CDx as a Companion Diagnostic for Piqray® (alpelisib) CAMBRIDGE, Mass.--(BUSINESS WIRE)- …

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