Oncocyte Corporation 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 LTs and puts its lab-developed tests and kitted products on parallel paths.

The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination product which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA's mission to protect and promote public health.

On September 29, 2023, the FDA announced this proposed rule: Medical Devices; Laboratory Developed Tests. The proposed rule seeks to amend the FDA's regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Under the FDA's proposed rule, laboratory-developed tests would be classified as medical devices and subject to premarket clearance and/or approval.