OncoCyte Expands Transplant Diagnostics with Key Partnerships

Published 1 hours agoOCX

OncoCyte Expands Transplant Diagnostics with Key Partnerships

OncoCyte Corporation is advancing its presence in the transplant diagnostics market through significant new agreements. The company has recently secured partnerships with top transplant centers in both the United States and Germany. These centers will use OncoCyte's GraftAssure™ assay, a specialized test designed to detect early signs of organ graft damage, according to a report by GlobeNewswire.

Supporting its diagnostics expansion, OncoCyte is making headway in FDA-related activities. The company is progressing with the development of a kitted clinical test product, having held a pre-submission meeting with the U.S. Food and Drug Administration on December 5, 2024. OncoCyte plans to submit this clinical test for FDA approval by the end of 2025, with hopes for authorization by 2026, as detailed by NatLawReview.

In a strategic move to align with future industry standards, OncoCyte is also embarking on a rebranding initiative. This shift is in anticipation of a broader transition in transplant care, where localized, real-time monitoring is expected to become standard practice by 2028. The company's efforts reflect its commitment to accessible and efficient transplant diagnostics, aiming to innovate and lead in this evolving field.

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OncoCyte Expands Transplant Diagnostics with Key Partnerships

OncoCyte Expands Transplant Diagnostics with Key Partnerships

OncoCyte Corporation is advancing its presence in the transplant diagnostics market through significant new agreements. The company has recently secured partnerships with top transplant centers in both the United States and Germany. These centers will use OncoCyte's GraftAssure™ assay, a specialized test designed to detect early signs of organ graft damage, according to a report by GlobeNewswire. Supporting its diagnostics expansion, OncoCyte is making headway in FDA-related activities. The company is progressing with the development of a kitted clinical test product, having held a pre-submission meeting with the U.S. Food and Drug Administration on December 5, 2024. OncoCyte plans to submit this clinical test for FDA approval by the end of 2025, with hopes for authorization by 2026, as detailed by NatLawReview. In a strategic move to align with future industry standards, OncoCyte is also embarking on a rebranding initiative. This shift is in anticipation of a broader transition in transplant care, where localized, real-time monitoring is expected to become standard practice by 2028. The company's efforts reflect its commitment to accessible and efficient transplant diagnostics, aiming to innovate and lead in this evolving field.

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