Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.
The company has achieved even higher specificity than earlier data demonstrated, and is now building up its sales and marketing infrastructure for the planned launch of its lung cancer test.
The certification creates a path to market for Mitra's CANScript test, which replicates a cancer patient's tumor microenvironment and predicts treatment outcomes.
In a letter to congressional leaders, the groups said they "believe strongly" that the FDA should play a critical role in developing a modernized framework.
The annual list includes guidelines that would clarify regulations for garnering premarket approval or clearance of devices and diagnostics, particularly next-generation sequencing tests.
