Welcome to our dedicated page for Oncocyte Corporation news (Ticker: OCX), a resource for investors and traders seeking the latest updates and insights on Oncocyte Corporation stock.
Oncocyte Corporation (OCX) delivers innovative molecular diagnostics through non-invasive liquid biopsy tests and transplant monitoring solutions. This news hub provides investors and healthcare professionals with timely updates on the company’s advancements in early cancer detection and organ rejection diagnostics.
Access official press releases, clinical trial milestones, and partnership announcements in one centralized location. Track developments across key areas including diagnostic product launches, regulatory progress, and strategic collaborations that shape Oncocyte’s role in precision medicine.
Our curated news collection features updates on proprietary technologies like VitaGraft Kidney and DetermaIO, alongside financial performance reports and research breakthroughs. Stay informed about how OCX’s digital PCR-based assays address critical needs in oncology and transplant care.
Bookmark this page for streamlined access to verified Oncocyte Corporation updates. Check regularly for new developments impacting diagnostic innovation and clinical decision-making tools.
Oncocyte (Nasdaq: OCX) reported significant progress in its clinical trial for an organ transplant rejection monitoring test kit. The company has secured Central Institutional Review Board approval and is set to partner with three of the top 10 U.S. transplant centers, representing nearly 10% of U.S. transplanted organ volume.
The company targets a $500 million U.S. market for transplant rejection testing, with a global opportunity exceeding $1 billion annually. Their innovative approach aims to enable transplant centers to perform testing locally, improving community care accessibility.
Key developments include:
- Pursuing Class II de novo pathway for FDA authorization
- Completed clinical trial design
- Final Q-Sub FDA meeting scheduled
- Previously achieved CLIA validation
- Secured CMS reimbursement for lab-developed version
The company plans to announce its National Principal Investigator and submit its data package in the second half of 2025.
Oncocyte (Nasdaq: OCX) has published new positive data on its blood-based transplant rejection assay in Transplantation Direct. The study, conducted at Charité University in Berlin, analyzed 131 patients with 151 kidney biopsies over four years, demonstrating long-term clinical validity for patients up to 13.7 years post-transplant.
The research revealed two key findings: 1) T-cell mediated rejection shows high elevation of dd-cfDNA when vascular inflammation is present, and 2) Calcineurin inhibitor toxicity doesn't increase dd-cfDNA levels. The study supports market expansion for testing high-risk patients, particularly those with de novo donor-specific antibodies.
Oncocyte is developing a kitted test for dd-cfDNA quantification and currently offers testing at its Nashville laboratory, which received Medicare reimbursement in 2023. The company aims to deliver more affordable, faster tests that can be run at local labs, positioning itself for commercial growth in transplant rejection monitoring.
Oncocyte (Nasdaq: OCX), a diagnostics technology company, has announced its participation in the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025. CEO Josh Riggs and CFO Andrea James will represent the company, with Riggs scheduled for a fireside chat on April 7, 2025, at 3:45 PM ET.
During the conference, the executives will discuss Oncocyte's innovative diagnostic technologies and highlight their progress in commercializing a regulated organ transplant rejection monitoring test kit. The company is pursuing a market-disruptive approach to lead in transplant monitoring solutions.
Investors interested in attending the virtual fireside chat or scheduling one-on-one meetings should contact their Needham sales representative.
Oncocyte (OCX) reported Q4 2024 revenue of $1.5 million and full-year revenue of $1.9 million, primarily from pharma services. The company achieved several key milestones in 2024:
- Launched GraftAssure RUO assay in July 2024
- Secured Bio-Rad Laboratories as strategic partner and investor (9.66% ownership)
- Raised $57 million in equity funding
- Expanded Medicare coverage for VitaGraft Kidney test
- Had successful FDA pre-submission meeting in December 2024
The company is developing a regulated organ transplant rejection monitoring test kit targeting a $1 billion addressable market. They aim for FDA submission by end of 2025 and authorization in 2026. Q4 2024 showed $595,000 gross profit (40% margin) and operating expenses of $34.2 million, including $41.9 million in non-cash impairment losses offset by $13.7 million non-cash gain from contingent consideration.
Oncocyte (Nasdaq: OCX), a diagnostics technology company, has scheduled its fourth quarter 2024 financial results announcement for March 24, 2025, after market close. The company will host a live Zoom webinar at 2:00 p.m. PT on the same day to discuss the results, followed by a Q&A session. Investors can access the webinar through registration, and a replay will be available on Oncocyte's investor relations website.
Oncocyte Corp (Nasdaq: OCX) has announced its participation in BTIG's MedTech, Digital Health, Life Science & Diagnostic Tools Conference taking place on February 11-12, 2025, in Snowbird, Utah. CEO Josh Riggs and CFO Andrea James will represent the diagnostics technology company at the event, where they will conduct one-on-one meetings with potential investors.
Interested investors attending the conference are encouraged to contact BTIG directly to schedule meetings with Oncocyte's leadership team.
Oncocyte Corp. (OCX) has secured $29.1 million through a registered direct offering and concurrent private placement priced at $2.05 per share. The funding round was led by the company's five largest shareholders, including strategic partner Bio-Rad Laboratories, who also committed additional support for clinical trials and commercialization.
The proceeds, combined with current cash, will fully fund the development of Oncocyte's FDA In-Vitro Diagnostic (IVD) transplant assay program. The company's proprietary technology can detect kidney transplant rejection signs over 11 months earlier than standard protocols. The offering includes 3,609,755 shares in the registered direct offering and 7,536,708 shares plus pre-funded warrants for 3,069,925 shares in the PIPE offering.
The transaction is expected to close on February 10, 2025, with Needham & Company acting as financial advisor. The company aims to capture share in the $1 billion global transplant testing market.
Oncocyte Corp (NASDAQ: OCX) has appointed Dr. Paul Billings as Consulting Chief Medical Officer in a part-time role. Dr. Billings, a renowned diagnostics specialist with over 40 years of experience, will support strategic and clinical goals for the company.
Dr. Billings previously served as CEO and Chairman at Biological Dynamics, focusing on exosome-based diagnostics for early cancer detection, and as Chief Medical Officer at Natera during key commercialization phases. He has held advisory and leadership positions at major companies including LabCorp, Quest Diagnostics, and Thermo Fisher Scientific.
Holding M.D. and Ph.D. degrees in immunology from Harvard University, Dr. Billings is board certified in internal medicine and medical genetics. He has held academic positions at Harvard, Stanford, and UC San Francisco, and served on Advisory Boards at the FDA and HHS.
Oncocyte (NASDAQ: OCX) announced expanded Medicare coverage for its VitaGraft Kidney diagnostic test, now including monitoring of patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). The expansion follows a study showing VitaGraft can detect AMR up to 11 months earlier than standard care.
The coverage was confirmed under MolDX's Local Coverage Determination (LCD) and includes two Z-codes for improved accessibility. This expansion targets a significant market, as up to 20% of patients develop detectable DSA within five years post kidney transplant, representing over 10,000 patients annually in the US. Notably, 24% of patients with dnDSA lose their allograft within 3 years, compared to a 96% five-year survival rate for patients without DSA.
The company aims to commercialize its proprietary diagnostic technology that enables local laboratories to run kitted tests measuring donor-derived cell-free DNA (dd-cfDNA), offering a more affordable and faster alternative to current methods.
Oncocyte Corp (Nasdaq: OCX), a diagnostics technology company, has announced its participation in 'J.P. Morgan Week' alongside the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13-16, 2025.
CEO Josh Riggs and CFO Andrea James will be available for one-on-one meetings with investors during the event. Interested investors can schedule meetings through Julie Silber at PCG Advisory.
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