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FDA Accepts Invitae Premarket Approval Submission for Stratafide Companion Diagnostic

NEW YORK – Invitae on Monday said that the US Food and Drug Administration has accepted a premarket approval application for the Stratafide next-generation sequencing companion diagnostic.

Invitae acquired the test after it bought ArcherDx last month for $1.4 billion. The regulatory submission to the FDA last week triggered a milestone payment, prompting Invitae to issue 5 million shares of its common stock to former ArcherDx securityholders.

Stratafide is a pan-solid tumor in vitro diagnostic that can identify genomic alterations in patients' tissue or blood samples, which in turn can be useful for guiding treatments or for identifying clinical trial opportunities. The test received breakthrough therapy designation from the FDA last year.  

In August, ArcherDx and Premier, a group purchasing organization, inked a multiyear partnership to study the capabilities Stratafide and explore how the distributed IVD is best utilized in a community hospital setting to improve access to targeted drugs among late-stage cancer patients. To start, the companies will retrospectively compare Stratafide's performance to other diagnostic tests using cancer patients' samples from around 10 institutions.