OncoCyte announces successful GraftAssure beta launch

Reports in a letter to shareholders, in part: “We are thrilled to report that we have successfully launched GraftAssure , which is our research-use-only assay that can detect early evidence of graft organ damage in a patient’s blood. On July 11 , our GraftAssure assay was run at a major metropolitan transplant center and research university in the northeast United States, representing the first time our test had been run outside of an Oncocyte lab. Days later, a lab at a leading transplant center in Southeast Asia began running the test. Though we believe this milestone is just the beginning, it’s an important proof point in an 18-month journey. To recap, in January 2023, we decided to double down on commercializing our transplant test IP, primarily by making a kitted test that relies upon a biomarker, donor-derived cell-free DNA . Our first prototypes of GraftAssure came off the manufacturing line in December. Four months later, in April 2024, we welcomed Bio-Rad Laboratories (BIO) as an investor and strategic partner, supporting the GraftAssure global launch. And in June 2024, we began shipping to our launch customers. We shipped to two continents in our first week – representing major transplant centers and research universities in the U.S. and Southeast Asia. As of today, we have signed up several centers in the U.S, Europe and Southeast Asia. We are also pleased with the momentum we are seeing coming out of the American Transplant Congress in Philadelphia in June. That conference was especially meaningful for Oncocyte this year because it coincided with the New England Journal of Medicine’s publication of favorable data regarding our centralized lab product VitaGraft Kidney1. That clinical product uses the same background IP as our GraftAssure kitted test. As a reminder, under our partnership, Bio-Rad and Oncocyte are co-marketing GraftAssure inside the US and Germany, with Oncocyte acting as commercial lead. Bio-Rad is acting as commercial lead outside the US and Germany, and correspondingly has been granted exclusive distribution and commercial rights in those countries.