OncoCyte begins FDA submissions process for VitaGraft transplant assays

Oncocyte 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 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. “Establishing our VitaGraft Assay Lab Developed Test as a regulated device is good for patients and is a key part of our regulatory strategy,” said Josh Riggs, CEO of Oncocyte. “With minimal incremental investment, we can take a big step forward. If we are successful, it potentially creates what is known as a predicate device. Having a predicate in place can significantly reduce the time and complexity of follow-on submissions to the FDA. We hope to use this pathway when it is time to submit our kitted product.”