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.