In an October 2, 2023, press release, Natera accounced it had submitted the first of several modules of a PMA application for its SIGNATERA test, as a companion diagnostic for muscle invasive bladder cancer. Read it here.
SIGNATERA is covered by MolDx for monitoring of disease recurrence and for monitoring of treatment response (typically of checkpoint inhibitor therapies).
This submission is for quality control systems, which "will support all future indications" of Signatera. Pending are submission of bladder-specific modules for software and analytical/clinical validation.
Natera just raised $250M in growth capital.