Oncocyte (NASDAQ:IMDX) is pushing for FDA marketing authorization of its GraftAssureDx kidney-transplant rejection test by the end of 2024, as the company ramps up commercial preparation and streamlines operational spending following its second-quarter earnings report.
Navigating the FDA Regulatory Path
During the Q2 earnings call, CEO Josh Riggs confirmed that the company received an additional information letter from the FDA in July regarding its Class II review. The agency requested further data and clarification on the test’s intended use—a move Riggs characterized as a routine part of the regulatory process. To support the resubmission, Oncocyte has tripled its sample collection since the initial March filing.
Before submitting the updated data package, Oncocyte intends to conduct a Submission Issue Request (SIR) meeting with the FDA to ensure full alignment with regulators. While the timeline remains subject to government review, Riggs emphasized that the FDA’s inquiries were expected and addressable with current data.
European Expansion and Regulatory Flexibility
Chief Science Officer Ekkehard Schütz provided an update on the company’s European strategy. Following consultations regarding the In Vitro Diagnostic Regulation (IVDR), Oncocyte remains on track to complete its submission in the second half of the year. Schütz noted that the European regulatory environment appears more flexible than the U.S. process, with no immediate requirement for large-scale clinical studies. Additionally, the company anticipates a more streamlined self-certification process in the United Kingdom.
Early market-access indicators are surfacing in Europe, with reimbursement progress in Switzerland and initial tender activity in Italy. Management believes broader adoption will be further catalyzed by the eventual approval of anti-CD38 therapies.
Medicare Tailwinds and Market Adoption
Oncocyte is positioning itself to benefit from expanded Medicare reimbursement guidelines for transplant rejection testing. The recent MolDX local coverage determination, which increased covered surveillance from eight to 14 tests in the first three years post-transplant, creates a compelling economic argument for transplant centers to adopt in-house donor-derived cell-free DNA (dd-cfDNA) testing.
Riggs highlighted that head-to-head clinical data proving the equivalence of Oncocyte’s assay to existing central laboratory tests is driving significant interest. Currently, more than half of the top 10 U.S. transplant centers are engaging with the company via its registry or FDA program.
Financial Outlook and Operational Discipline
CFO Andrea James reported an adjusted EBITDA loss of $7.8 million for the second quarter, noting that core spending has decreased from the peak seen in Q4 2025. Cash burn for the quarter reached $10 million, a figure management expects to be the near-term high point as they maintain strict cost discipline.
The company projects modest revenue in the second half of the year from laboratory services and its GraftAssure CORE laboratory-developed test, which is reimbursable at $2,753 per result. To extend its cash runway, Oncocyte is exploring various levers, including accelerated registry enrollment and potential partnerships—specifically noting ongoing engagement with Bio-Rad regarding platform placement at transplant and reference laboratories.
Strategic Growth Beyond Kidney Transplants
Oncocyte continues to eye a $2 billion total addressable market for kitted transplant testing, with plans to expand its footprint into heart-transplant monitoring. The company has scheduled a key opinion leader call for August 17 to discuss the clinical application of in-house dd-cfDNA testing for heart patients, signaling a broader commitment to diversifying its diagnostic portfolio.