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Cologuard Receives FDA Nod for CRC Diagnosis
Cologuard had received recommendation for premarket approval from a FDA advisory panel back in March.
The US Food and Drug Administration (FDA) today approved Cologuard (Exact Sciences Corporation), a stool-based colorectal cancer (CRC) in vitro diagnostic device.
Cologuard analyzes stool specimens to detect hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA contained in cells that are shed by CRC or advanced adenomas into the colon.
The test is intended to be used as an adjunctive screening test to detect colorectal neoplasia-associated DNA markers and the presence of occult hemoglobin in human stool. A positive test result may indicate the presence of CRC or premalignant colorectal neoplasia. The device is not meant to be a replacement for colonoscopy and is intended to be used in conjunction with colonoscopy and other test methods according to recognized screening guidelines.
Read the original report: http://bit.ly/1r6NS0v
Source: Medscape
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Trastuzumab Deruxtecan Receives FDA Approval for HER2-Positive Solid Tumors
April 5th 2024FDA granted accelerated approval to trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.
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