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IRVINE, Calif. - Oncocyte Corp. (NASDAQ:OCX), a diagnostics technology company, has announced the publication of a study validating the effectiveness of its DetermaIO™ test in identifying breast cancer patients who may benefit from the immunotherapy drug atezolizumab. The study, published in the peer-reviewed journal Clinical Cancer Research, focused on patients with triple-negative breast cancer (TNBC), a particularly aggressive form of the disease.
The NeoTRIP Phase 2 clinical trial evaluated the DetermaIO test's predictive ability among various established biomarkers. Patients with early-stage TNBC were randomized to receive standard chemotherapy with or without atezolizumab. The results demonstrated that patients testing positive with DetermaIO (IO+) had a significantly higher pathologic complete response (pCR) rate when treated with the combination of atezolizumab and chemotherapy (69.8%) compared to chemotherapy alone (46.9%). Conversely, DetermaIO-negative (IO-) patients did not show a significant improvement in pCR rates with the addition of atezolizumab.
Oncocyte CEO Josh Riggs expressed optimism about the findings, stating that the data clearly demonstrate DetermaIO's ability to identify patients more likely to benefit from immunotherapy. The company plans to use this study to support its submission for CMS reimbursement coverage, aiming to broaden access to the test.
The study was conducted in collaboration with the Michelangelo Foundation for Cancer Research and further validates Oncocyte's direction in research and development, which seeks to provide clarity and confidence in diagnostics to improve patient outcomes.
Oncocyte is also developing products for organ transplant testing and is commercializing its transplant product line, including the VitaGraft™ and GraftAssure™ tests, with GraftAssure being launched globally with the support of Bio-Rad Laboratories (NYSE:BIO).
This news is based on a press release statement and the company's forward-looking statements involve risks and uncertainties. Oncocyte emphasizes its commitment to democratizing access to molecular diagnostic testing and is expected to commercialize its oncology product line, including DetermaIO, within the next 18 months.
In other recent news, OncoCyte (NASDAQ:OCX) Corporation discussed its Q2 2024 financial and operational performance, focusing on the successful commercial launch of its transplant diagnostic product, GraftAssure. The company also revealed its plans to submit its in-vitro diagnostic (IVD) product to the FDA by summer 2025, with market coverage expected in late Q4. OncoCyte's partnership with Bio-Rad and its strategic focus on test kits, moving away from an in-house clinical lab model, were also highlighted.
The recent appointment of Andrea James as CFO was cited as an important step towards the company's goal of becoming a $1 billion entity within the next 5 to 10 years. Despite acknowledging a weak balance sheet as a small company, OncoCyte remains confident in its growth strategy, backed by its strategic investment and partnership with Bio-Rad and scientific validation. The company is optimistic about its growth and market fit, with proactive interest from research centers.
These developments underline OncoCyte's ambition to disrupt the transplant testing market, with a particular focus on site adoption in the US and Germany. The company also aims to capture a $1 billion market opportunity in transplant testing by meeting demand and expanding into therapeutic efficacy and recurrence monitoring.
InvestingPro Insights
As Oncocyte Corp. (NASDAQ:OCX) advances its diagnostic technologies, particularly with the promising results of its DetermaIO™ test, investors should consider some key financial metrics and insights provided by InvestingPro.
According to InvestingPro data, Oncocyte's market capitalization stands at $40.26 million, reflecting its position as a smaller player in the biotechnology sector. The company's revenue for the last twelve months as of Q2 2024 was $1.02 million, with a concerning revenue growth decline of -7.08% over the same period. This aligns with an InvestingPro Tip indicating that analysts anticipate a sales decline in the current year.
Despite the positive clinical results for DetermaIO, Oncocyte faces financial challenges. An InvestingPro Tip reveals that the company is quickly burning through cash, which is a critical consideration for a biotech firm in the development and commercialization stages. This cash burn rate could impact Oncocyte's ability to bring its promising diagnostics to market without additional funding.
On a positive note, Oncocyte holds more cash than debt on its balance sheet, providing some financial flexibility as it works towards commercializing its product line. However, with a price-to-book ratio of 1.77, the stock may be considered relatively expensive compared to its book value.
Investors should note that Oncocyte is not currently profitable, with a negative P/E ratio of -1.71 for the last twelve months as of Q2 2024. This is consistent with another InvestingPro Tip suggesting that analysts do not anticipate the company will be profitable this year.
For those interested in a more comprehensive analysis, InvestingPro offers additional tips and metrics that could provide deeper insights into Oncocyte's financial health and market position. There are 7 more InvestingPro Tips available for OCX, which could be valuable for investors considering the stock's potential in light of its recent clinical success.
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