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Need Better Regulation for Next Gen Sequencing Tests, AMP Urges the FDA
The Association for Molecular Pathology has provided comments to the FDA, urging increased regulation of next generation sequencing diagnostic tests to ensure consistent and proper performance of the tests.
The Association for Molecular Pathology (AMP), the premier global, nonâ€profit organization serving molecular diagnostic professionals, submitted written comments on March 20 to the FDA in response to the agency’s request for feedback in association with its February 20, 2015 public workshop entitled, “Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” In its comments, AMP urged FDA to focus its attention on helping to ensure the performance characteristics of next generation sequencing (NGS) instruments, reagents, and related software. AMP further recommended that FDA partner with private sector organizations and experts to set standards for FDAâ€cleared or approved instruments, test kits, and software.
Link to the complete press release:
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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