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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Minute Insight: Thermo Fisher Gets FDA OK On Cancer Companion Diagnostic
The US FDA has approved additional indications for Thermo Fisher Scientific’s Oncomine Dx Target, allowing the companion diagnostic to be used to detect more varieties of lung and thyroid cancer.
Diagnostics 2018: Steady Progress And The Big Get Bigger
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.
US Approvals Analysis: Hits Just Keep On Coming. Can It Last?
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.