Bryan Loy, MD, discusses how the FDA approval process for emerging diagnostic tests is becoming more rigorous and well defined. He notes that this guidance should be of help in theplanning stages of test development. Dr Loy explains that many of these tests are being developed in the laboratory industry rather than the pharmaceutical industry. He insists that innovation should not be stifled, and that it is in everyone’s interest to move tests quickly through the approval process to market while ensuring their validity.
Dr Loy is uncertain about how well providers really understand the development process, or in some cases, even the quality, the analytic validity, and the methodology of those tests. Therefore, adoption will be based on a variety of factors including price point, accessibility, decentralization, interpretability of the information, ease of doing business, and ability to return results fast enough to avoid delaying therapy.
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.
Listen
FDA Approves Tislelizumab for Advanced or Metastatic ESCC After Chemotherapy
March 15th 2024The FDA has approved tislelizumab-jsgr (Tevimbra) for single-agent use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.
Read More