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IRVINE, Calif. - Oncocyte Corp. (NASDAQ:OCX), a diagnostics technology company with a market capitalization of $89.23 million and year-to-date stock return of 31.09%, has announced significant progress in initiating a pivotal clinical trial for its organ transplant rejection monitoring test kit. The trial design has been approved by a central institutional review board (IRB), and within the next few weeks, three leading U.S. transplant centers are expected to join as participants, representing nearly 10% of the nation’s transplant volume.
The trial’s outcome could pave the way for Oncocyte to obtain FDA authorization to market its test kit, which would enable transplant centers to locally perform rejection testing, currently estimated to generate $500 million annually in the U.S. The global market for such testing is valued at over $1 billion. While the company maintains a moderate debt level and healthy current ratio of 1.62, InvestingPro analysis indicates it is currently operating at a loss with last twelve months revenue of $1.88 million. Oncocyte’s test quantifies donor-derived cell-free DNA (dd-cfDNA), a biomarker for transplant rejection.
Oncocyte’s partnership with Bio-Rad, established in April 2024, has been instrumental in reaching this stage. The company is targeting the submission of its data package in the second half of this year. A National Principal Investigator (NPI) will soon be announced, followed by a conference call to introduce this key opinion leader to the medical and investor communities.
Oncocyte is pursuing a Class II de novo pathway for FDA authorization, which applies to lower-risk medical devices. The company has already achieved CLIA validation and reimbursement for the lab-developed version of the test with the Centers for Medicare & Medicaid Services (CMS).
The company also expects to complete its second and final Q-Submission (Q-Sub) meeting with the FDA shortly, which is a formal process for requesting feedback before applying for product authorization. Dr. Johnson Chiang, Chief Technology Officer of Oncocyte, expressed satisfaction with the FDA’s engagement thus far.
This announcement is based on a press release statement from Oncocyte Corporation. The company’s mission is to democratize access to advanced molecular diagnostic testing to enhance patient care. According to InvestingPro, which offers comprehensive analysis of over 1,400 US stocks, Oncocyte maintains a gross profit margin of 44.02% despite its development stage status. Investors can access detailed financial health metrics, growth projections, and 7 additional ProTips through the InvestingPro platform.
In other recent news, OncoCyte Corp reported its Q4 2024 earnings, highlighting $1.5 million in revenue from its pharma services with a 40% gross margin. The company ended the year with $10 million in cash reserves and successfully raised an additional $29 million in February 2024. OncoCyte also announced changes to its independent accounting firm, engaging CBIZ CPAs P.C. following the acquisition of Marcum LLP’s attest business. Lake Street Capital Markets initiated coverage on OncoCyte with a Buy rating and a price target of $5.00, citing the company’s innovative approach to transplant rejection testing. Needham maintained its Buy rating with a consistent price target of $4.25, noting OncoCyte’s successful co-marketing efforts and strategic partnerships. OncoCyte’s recent study demonstrated the effectiveness of its blood-based assay for transplant rejection, which could expand its market applications. These developments reflect the company’s strategic focus on advancing its transplant diagnostics technology and strengthening its financial position.
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