Oncocyte Corporation Stock Price, News & Analysis

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.

Oncocyte Corp. (OCX) announced favorable data for its DetermaCNI™ assay in diagnosing brain tumors through liquid biopsy. Published in Acta Neuropathologica Communications, the study showed the assay's ability to measure somatic copy number aberrations (SCNAs) in cerebrospinal fluid for diagnosing central nervous system tumors.

The study detected SCNAs in 10 out of 12 patients with confirmed central nervous system cancers, while showing no SCNAs in 11 patients with benign lesions. This technology could benefit nearly 300,000 U.S. patients annually who face primary brain tumors or brain metastasis, representing a potential $300 million U.S. market opportunity. The method could provide a less invasive alternative to current brain tissue biopsies.

Oncocyte announced favorable data for its VitaGraft Kidney diagnostic assay, published in Nephrology Dialysis Transplantation. The study demonstrates the test can detect antibody-mediated rejection (AMR) in kidney transplant recipients approximately 11 months earlier than standard protocols. Using donor-derived cell-free DNA (dd-cfDNA) testing, VitaGraft diagnosed AMR in a median of 2.8 months compared to 14.5 months with standard care in patients with donor-specific antibodies. This marks the first randomized interventional study validating dd-cfDNA as a rule-in test for biopsy in high-risk populations.

Oncocyte (OCX) reports progress in commercializing its transplant rejection testing technology. The company has signed agreements with leading transplant centers in the U.S., Germany, Switzerland, Austria, and the U.K. Their customers now represent about 9% of German transplant volumes and 2% of U.S. transplant volumes. The company is on track to sign 20 transplant centers by end of 2025, with each center potentially generating annual revenue of several hundred thousand to $2 million. The FDA pre-submission process for their kitted clinical test is underway, with a meeting scheduled for December. The company recently raised $10.2 million through a private placement at market price of $2.948 per share.

Oncocyte Corp (Nasdaq: OCX) has announced it will release its third quarter 2024 financial results on Tuesday, November 12, 2024, after U.S. market closes. The company will host a conference call and webcast at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time on the same day. Investors can access the call via toll-free number 800-715-9871 for domestic callers or +1 (646) 307-1963 for international callers, using Conference ID 4153469. A webcast replay will be available on the company's website after the call.

Oncocyte Corp (NASDAQ: OCX), a diagnostics technology company, announced its participation in the 17th annual LD Micro Main Event in Los Angeles. CEO Josh Riggs is scheduled to present on Tuesday, October 29th at 2:30 PM PT at The Luxe Sunset Boulevard Hotel. The company's management will also be available for one-on-one meetings with investors.

The LD Micro Main Event XVII will run from October 28th to 30th, featuring approximately 150 companies presenting in half-hour increments and attending private meetings with investors. Registration begins on October 28th at 3:00 PM PT, followed by keynotes and a happy hour. Presentations will run from 8:00 AM to 5:00 PM PT on October 29th and 30th.

Oncocyte Corp. (Nasdaq: OCX) has announced positive data for its DetermaIO™ gene expression test in a peer-reviewed publication. The NeoTRIP Phase 2 clinical trial assessed DetermaIO's ability to predict which triple-negative breast cancer (TNBC) patients would benefit from adding atezolizumab (immunotherapy) to chemotherapy.

Key findings include:

• DetermaIO-positive patients showed a significantly higher pathologic complete response (pCR) rate with atezolizumab plus chemotherapy (69.8%) compared to chemotherapy alone (46.9%).
• DetermaIO was the only biomarker among those tested that significantly predicted pCR benefit from adding atezolizumab.
• Results were further validated using data from the I-SPY2 Trial with pembrolizumab.

Oncocyte aims to commercialize DetermaIO within 18 months, targeting a multi-billion-dollar oncology diagnostics market.

Oncocyte (Nasdaq: OCX) has announced new agreements with two leading transplant university hospitals in the U.S. and Germany to utilize GraftAssure™, the company's research-use-only assay for detecting early evidence of graft organ damage. This development is part of Oncocyte's strategy to drive commercial adoption of its molecular diagnostic tests in the estimated $1 billion transplant addressable market.

The company has also submitted its plan for an in-vitro diagnostic (IVD) version of its dd-cfDNA kitted test to the FDA, initiating the Q-submission process. A meeting with the FDA is scheduled for early December. Oncocyte aims to begin the validation process in early 2025.

Since August 2024, additional transplant centers have committed to adopting GraftAssure. Oncocyte partnered with Bio-Rad Laboratories in April 2024 for global launch support, with Bio-Rad having exclusive distribution rights outside the U.S. and Germany.