IN BRIEF: GENinCode says still deficiencies in US De Novo submission
7th Jul 2025 21:56
GENinCode PLC - Oxford, England-based genetics testing company - Provides update on its US Food and Drug Administration submission for De Novo. "While the number of the outstanding deficiencies has been reduced, the review upheld the FDA's prior view that there remains certain outstanding elements, including further information in relation to clinical validation." The FDA had determined in April that certain outstanding elements in De Novo needed to be addressed, including deficiencies in relation to clinical validation. Read More