Oncocyte Reports Commercial Launch Progress; On Track to Sign 20 Transplant Centers by End of 2025

In This Article:

OncoCyte Corporation
OncoCyte Corporation
  • Transplant centers representing about 9% of German transplant volumes and about 2% of U.S. transplant volumes have signed on to use GraftAssure kitted research test in early launch phase

  • FDA pre-submission process for approval of kitted clinical test is underway

IRVINE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Oncocyte Corporation (Nasdaq: OCX) (“Oncocyte” or the “Company”), a diagnostics technology company, today published the following letter to shareholders in conjunction with its third quarter results:

Fellow Shareholders,

We are pleased to report that we are making considerable progress on two fronts that help de-risk our path to meaningful revenue. First, we are continuing to sign new research customers at well-respected hospitals and universities. In addition to the two customers mentioned in our August update, we have now signed agreements with two leading transplant university hospitals in the U.S. and Germany, as well as major research hospitals in Switzerland, Austria, and the U.K. Given the concentrated nature of the transplant market, we believe each new customer represents a key step toward capturing an estimated $1 billion global total addressable market for our transplant rejection testing technology.

Second, our clinical kitted test product development remains on track, and we have already had productive dialogue with the U.S. Food and Drug Administration (FDA), which we describe below.

The international response to GraftAssure™, which is our research-use-only assay that can detect early evidence of graft organ damage, is exceeding our expectations. We attribute this success to our robust research partnerships in Europe, and to our team’s scientific leadership in researching the dd-cfDNA biomarker1 for over a decade. Our customers in Germany now represent about 9% of the country’s annual organ transplant volumes.2

Additionally, we are making inroads toward capturing share in the much larger U.S. market. In August, we reported that our U.S. sales funnel represents 25% of transplant volumes. Three months later, we are pleased to report that hospitals representing about 2% of overall organ transplant volumes3 have now signed up to use GraftAssure.

We also received significant interest and engagement from the transplant lab community at the American Society for Histocompatibility & Immunogenetics (ASHI) conference in Anaheim in October. This continuous positive reinforcement from the customer base gives us confidence that we are on the right track.

Executive summary

Oncocyte is at a pivotal stage in commercializing our IP in organ transplant, primarily by making a kitted test that quantifies an established biomarker, donor-derived cell-free DNA (dd-cfDNA), and uses a digital-PCR workflow that we believe offers distinct advantages over assays run on Next-Generation Sequencing (NGS) technology. Our scientists have played a pivotal role over the past decade in developing the science that established dd-cfDNA as a trusted biomarker4, and we are now commercializing a product by pursuing a market disruptive approach. We aim to deliver proven, more affordable, faster tests that can be run at local labs.

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