Podcast: Thermo Fisher Talks Regulatory Experience With Oncomine
US FDA recently approved Oncomine Dx Target Test, the first multi-drug next-generation sequencing test made by Thermo Fisher Scientific. The test is a companion diagnostic for lung-cancer drugs made by Novartis and Pfizer, and the diagnostic company is looking to expand its partnership to other pharma companies.
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If the beginning of 2017 was marked by doubts around whether and how the FDA would act with respect to complex diagnostics, we enter 2018 feeling that slow-moving vessel may finally be turning.
2017 was another record year for novel device approvals in the US, with typical large numbers of cardiovascular and IVD go-aheads, along with notable successes in neurology, with noninvasive stimulation and digital-app solutions seeing success. There was also an increase in 510(k) clearances last year. Here's a look at some key FDA approvals and clearance trends from the past year, including in infographic form.
FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.