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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.

Laboratory
Thermo Fisher's Oncomine Dx Target Test is the first multi-drug next-generation sequencing test approved by US FDA • Source: Thermo Fisher Scientific

Thermo Fisher Scientific Inc. announced last month it received US FDA approval of its Oncomine Dx Target Test, the first next-generation sequencing test approved for multiple drugs. Because of the uniqueness of the test and regulatory path it took, Medtech Insight spoke to Joydeep Goswami, president of the Clinical Sequencing Division in the firm's Life Sciences Group, to learn more.

Oncomine was developed by Thermo Fisher and used by the National Institutes of Health to study various forms of non-small cell lung cancer (NSCLC). Eventually the company entered into partnerships...

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