FOSTER CITY, Calif., March 3, 2026
Adela, Inc. has announced the publication of new clinical validation data in npj Precision Oncology demonstrating that its innovative tissue-free blood test can effectively monitor patient response to immunotherapy in advanced solid tumors. The study highlights how changes in methylated circulating tumor DNA (ctDNA) detected through a blood sample may provide early insights into treatment effectiveness, potentially allowing oncologists to make faster and more informed decisions about continuing or adjusting therapy. The findings underscore the growing importance of liquid biopsy technologies in precision oncology, where non-invasive molecular monitoring is increasingly used to guide treatment strategies and improve patient outcomes.
Tissue-Free ctDNA Test Enables Early Treatment Monitoring
Adela’s blood-based diagnostic platform measures genome-wide DNA methylation patterns to detect circulating tumor DNA in patient blood samples, providing a non-invasive method to monitor tumor activity during treatment. Unlike many existing molecular monitoring tools that require tumor tissue samples, Adela’s test is tissue-free, meaning it can be applied broadly to patients regardless of whether tumor biopsy material is available.
The clinical validation study analyzed blood samples collected from 64 patients with advanced solid tumors, including head and neck cancer, breast cancer, ovarian cancer, melanoma, and other tumor types. These patients were receiving immunotherapy with the checkpoint inhibitor pembrolizumab as part of the INSPIRE clinical study conducted at the Princess Margaret Cancer Centre within the University Health Network. Blood samples were collected before treatment initiation and again prior to the third treatment cycle, allowing researchers to evaluate whether changes in methylated ctDNA levels correlated with treatment response.
The results demonstrated that patients who experienced a decrease in methylated ctDNA levels between pre-treatment and cycle three were significantly more likely to respond positively to immunotherapy, suggesting that ctDNA monitoring could serve as an early biomarker of treatment effectiveness.
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Strong Clinical Associations with Response and Survival
The study revealed compelling clinical correlations between ctDNA changes and patient outcomes. Patients with decreasing methylated ctDNA levels showed significantly higher objective response rates and greater clinical benefit compared with patients whose ctDNA levels increased. Statistical analysis indicated an objective response odds ratio of 31.77 and a clinical benefit odds ratio of 15.55, highlighting the strong predictive value of this biomarker.
In addition to response rates, the blood test also demonstrated strong associations with survival outcomes. Patients showing decreases in methylated ctDNA experienced significantly longer progression-free survival and improved overall survival, with hazard ratios of 0.27 for progression-free survival and 0.49 for overall survival. These findings indicate that the test could serve as a powerful early indicator of whether patients are benefiting from immunotherapy treatment.
Currently, clinicians typically rely on radiographic imaging to assess tumor response, which can delay recognition of treatment failure because imaging changes may take several months to become apparent. By contrast, ctDNA analysis provides molecular evidence of tumor activity much earlier, potentially enabling physicians to modify treatment plans sooner and avoid unnecessary toxicity from ineffective therapies.
Precision Oncology Platform Supports Drug Development
Adela’s technology is based on a proprietary genome-wide methylome enrichment platform, which captures epigenetic signals across the entire methylome rather than focusing on a limited number of genetic mutations. This approach allows the test to detect cancer-related signals across many tumor types, making it suitable for broad application across solid tumors and diverse clinical settings.
The company reports that the test is already being used by biopharmaceutical companies and clinical researchers for biomarker discovery and drug development, particularly in studies evaluating immunotherapy treatments. By providing early insights into treatment response, the platform may help accelerate clinical trials and support more efficient development of new cancer therapies.
In addition to immunotherapy monitoring, Adela’s test has also been clinically validated for detecting and monitoring recurrence in head and neck cancer, demonstrating the versatility of the technology in cancer management.
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Looking ahead, the company plans to commercialize the blood test later in 2026, making it available for clinical use in patients receiving immunotherapy for solid tumors. If widely adopted, the technology could significantly enhance the ability of oncologists to personalize treatment strategies, improve patient outcomes, and reduce unnecessary exposure to ineffective therapies.
As precision oncology continues to evolve, non-invasive molecular diagnostics such as methylated ctDNA testing are expected to play an increasingly central role in guiding cancer treatment decisions, helping clinicians deliver more targeted and responsive care for patients with advanced disease.
Source: Adela, Inc. press release
