US Policy-Makers Prioritize Liquid Biopsies
Liquid biopsies have been a priority topic for policy development by US FDA and the broader Obama administration. During the past year, FDA has kicked itself into high gear to provide test-makers with more insight into its thinking and, this summer, the agency approved the first liquid biopsy test.
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Guardant Looking Ahead To Insurers, FDA On Liquid Biopsy
Guardant Health recently announced that the first US health insurance plan covered its Guardant360 liquid biopsy system. CEO Helmy Eltoukhy spoke to Medtech Insight about the milestone and the firm's plans to gain FDA approval as the agency moves to oversee laboratory-developed tests. Read the story and listen to the podcast interview.
US FDA's Next-Gen Sequencing Guidances: One Stop On A Pathway
Two recent next-generation sequencing draft guidances have been positively received so far by industry and clinical research groups. But for FDA's ideas to play out, more databases will need to be populated and more standards developed, agency officials say. There are also more guidances to come on different types of NGS tests. Read our coverage below, and also listen to our podcast interview with FDA's Elizabeth Mansfield.
'Moonshot' Opportunities: Dx Reimbursement, Radiation Therapy Among Medtech Focal Points
Personalized-medicine advocates say Vice President Biden's "Cancer Moonshot" initiative is a great opportunity, but it should be putting more focus on the importance of Medicare policies in driving cancer innovation. There is also a push in the medtech space to raise the profile of radiation therapy as a central tool for treating cancer.