OncoCyte Corp. is a molecular diagnostics company, which engages in the development and commercialization of diagnostic tests for the detection of cancer, including molecular diagnostic services to pharmaceutical customers. Its products include DetermaRx and DetermaIO. The firm also offers pharmaceutical services like multi-analyte test development and clinical trial services. The company was founded in September 2009 and is headquartered in Alameda, CA.
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- The global kidney transplant rejection biomarker market is projected to grow from USD 1,362.8 million in 2026 to USD 3,975.3 million by 2036 at an 11.3% CAGR, driven by increasing adoption of non-invasive liquid biopsy testing. - Donor-derived cell-free DNA (dd-cfDNA) is expected to hold 31.1% of the biomarker type segment in 2026, supported by blood-based sampling and measurable graft-derived injury signals across repeat surveillance visits. - A June 2024 Nature Medicine study covering 2,882 recipients across 14 centers has built confidence for liquid biopsy use in kidney transplant surveillance, accelerating clinical adoption. - Japan leads country-level growth at 13.7% CAGR, followed by the UK at 12.1% and the USA at 11.1%, with transplant centers projected to capture 44.0% of end-user share in 2026.
- Insight Molecular Diagnostics (iMDx) has appointed Steven Tahmooressi as Vice President of Marketing to lead the commercial launch of its GraftAssureDx transplant rejection diagnostic kit. - The company is preparing for FDA authorization of GraftAssureDx in 2025, targeting the estimated $1 billion addressable market for kitted transplant rejection testing. - Tahmooressi brings 25 years of healthcare industry experience, including global commercialization expertise in transplantation, oncology, and immunology from previous roles at Astellas Pharma, Abbott Laboratories, and Bristol-Myers Squibb. - The GraftAssure family of assays measures donor-derived cell-free DNA (dd-cfDNA), an established biomarker of transplant rejection, with the clinical kit designed to expand testing access for kidney transplant patients.
- iMDx has enrolled its first patient in the GraftAssureDx clinical trial, an observational study designed to validate a kitted transplant rejection monitoring test for kidney transplant recipients. - The trial now includes 10 leading transplant centers, up from five previously, with plans to enroll up to 125 patients by year-end. - The company remains on track for FDA submission by end of 2025 and commercial launch in 2026, targeting the estimated $1 billion addressable market for kitted transplant rejection testing. - GraftAssureDx would be the third version in the GraftAssure family, following GraftAssureCore which achieved Medicare reimbursement of $2,753 per result.
- iMDx's digital PCR-based GraftAssureIQ test demonstrated equivalent donor-derived cell-free DNA measurements compared to next-generation sequencing platforms in a head-to-head study of 96 kidney transplant recipients. - The University Hospital Heidelberg study represents the first direct comparison of two commercially available dd-cfDNA test kits based on single nucleotide polymorphisms, with digital PCR showing improved analytical sensitivity for detecting low-quantity dd-cfDNA. - Results support iMDx's preparation for commercial launch following expected regulatory approval next year, targeting the estimated $1 billion transplant rejection testing market. - Extended study data will be presented at the European Society of Organ Transplantation Congress in London from June 29 to July 2, 2025.
