The US Food and Drug Administration (FDA) recognizes the value of liquid biopsy in managing patients with cancer, and the agency is actively working to bring these assays to the clinic. Harpreet Singh, MD, Director of […] Read more
The US National Cancer Institute (NCI), a division of the US National institutes of Health (NIH), is partnering with Cancer Research UK, the world’s largest independent cancer research charity, to […] Read more
The US Food and Drug Administration (FDA) granted Accelerated Approval to pralsetinib as treatment for adults with metastatic NSCLC who harbor RET fusions. The first and only test to identify RET fusion–positive NSCLC, the Oncomine Dx Target […] Read more
August 2020 was a groundbreaking month for liquid biopsy technology, with two assays approved by the US Food and Drug Administration (FDA) as companion diagnostics just weeks apart. The Guardant360 CDx assay, approved August 7, was […] Read more
Harpreet Singh, MD, is director of Division of Oncology 2 at the U.S. Food and Drug Administration (FDA). In the following interview, she discusses the FDA’s response to the COVID-19 […] Read more
Posted: November 12, 2019 Dr. Matthew Steliga, chair of the IASLC Tobacco Control and Smoking Cessation Committee and thoracic surgeon and head of the Tobacco Cessation Program at Winthrop P. […] Read more
New Lung Cancer Screening Guidelines Will Save Lives Reaction was swift and positive last week to new draft guidelines from the U.S. Preventive Services Task Force lowering the requirements for […] Read more
Nivolumab in the News The dosing schedule for nivolumab now includes a flat dose of 480 mg infused every 4 weeks (Q4W) for a majority of approved indications, including patients […] Read more
Tumors with high TMB responded well to combination in large patient population. By now the results of the phase III CheckMate-227 study are known by most. The primary endpoint of […] Read more
The FoundationOne CDx (F1CDx) test received full U.S. Food and Drug Administration (FDA) approval. F1CDx is the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic (IVD) test to detect genetic mutations […] Read more