Oncocyte Begins FDA Submissions Process for VitaGraft Transplant Assays
– Significant unmet need for regulated product in $2B US testing market
– Opportunity for expedited pathway for kitted product in development
IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq:OCX), a precision diagnostics company, today announced it has begun the FDA single-site process for its VitaGraft transplant assays. The single-site process is a well-established pathway for Lab Developed Tests (LDTs) to seek regulatory approval. This move positions Oncocyte within the recent proposed rule from the FDA that seeks to oversight LDTs and puts its lab-developed tests and kitted products on parallel paths.
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