Oncocyte (OCX) Stock News

Oncocyte (OCX) announced that Medicare has increased the reimbursement rate for its GraftAssureCore™ assay to $2,753 per result, up from the previous structure of $2,222 for first-time testing and $1,029 for subsequent tests. The test, which detects transplant rejection through dd-cfDNA biomarker analysis, is performed at Oncocyte's CLIA-certified Nashville lab. The improved reimbursement rate strengthens the company's position in the transplant rejection testing market and suggests potential upside to its estimated $1 billion total addressable market. The new rate will help establish a reimbursement pathway for GraftAssureDx, Oncocyte's future kitted test planned for FDA submission by end-2025. The company also reported progress on its FDA submission process, with approval from a Central Institutional Review Board and expected participation from three of the top 10 U.S. transplant centers in its clinical trial.

Oncocyte (OCX) reported Q1 2025 results with pharma services revenue of $2.1M at 62% gross margin, up from 40% in Q4 2024. The company is advancing its transplant rejection testing technology, with three of the top 10 U.S. transplant centers expected to join clinical trials. Currently, ten leading transplant hospitals globally are using GraftAssure research-use-only kits. The company is pursuing FDA clearance through a Class II de novo pathway, targeting commercialization in 2026. The total addressable market for transplant rejection testing is estimated at $1 billion. Q1 financial highlights include a net loss of $6.7M ($0.26/share) and a cash position of $32.7M. The company plans to rename itself in Q2 2025 to better reflect its expanded focus beyond oncology into transplant diagnostics.

Oncocyte (Nasdaq: OCX), a diagnostics technology company, has scheduled its first quarter 2025 financial results announcement for May 12, 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. Interested participants can access the webinar through registration, and a replay will be available on Oncocyte's investor relations website afterward.

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.