Adela’s tissue-agnostic MRD test has been clinically validated to predict and surveil for recurrence in patients with head & neck cancer, regardless of HPV status

The test identified recurrences in head & neck cancer up to 14.9 months before standard of care clinical exam and imaging

FOSTER CITY, Calif., Sept, 14 2024 /PRNewswire/ -- Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, has successfully completed clinical validation of its MRD test to predict and surveil for recurrence in head & neck cancer. Results have been published in Annals of Oncology1 and are being presented during an Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2024.

“Blood-based MRD testing has the potential to transform recurrence monitoring for patients with head & neck cancer. Currently, the majority of recurrences are not detected until symptoms or physical findings are reported by the patient2. By identifying signals of disease prior to clinical presentation or routine imaging with MRD testing, recurrences can be treated earlier and more effectively,” said Geoffrey Liu, MSc, MD, Medical Oncologist and Senior Scientist, Princess Margaret Cancer Centre, University Health Network (UHN). “The clinical validation results from Adela’s MRD test demonstrate that the test identified recurrences up to 14.9 months earlier than standard of care clinical exam and imaging.”

The ability of Adela’s test to quantify cfDNA cancer signal and predict and surveil for recurrence was evaluated in individuals diagnosed with stage I-IVB human papillomavirus (HPV)-positive oropharyngeal and HPV-negative head and neck cancer treated at Princess Margaret Cancer Centre, University Health Network. This comprehensive patient cohort, based on rigorous data collection, provided a strong foundation for evaluating the test’s performance. The full study cohort included >1,100 plasma samples collected from >300 patients. 484 plasma samples from 149 patients were included in the validation analysis. In the study, blood draws occurred before and after curative intent treatment, and in a subset of patients, at mean 12 and 24 months post-curative intent treatment.

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In the validation analysis, Adela’s MRD test demonstrated the ability to identify recurrences up to 14.9 months before standard of care clinical exam and imaging, with a mean lead time of 4.1 months. Sensitivity for recurrence in the surveillance setting was 91% at 88% specificity. Significant differences in recurrence-free survival (RFS) were observed when patients were stratified by MRD positivity (HR of 35.7 (P<0.001)). MRD status showed significant association with RFS in both HPV-positive and HPV-negative disease.

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“We are highly encouraged by the validation results of Adela’s MRD test, demonstrating strong test performance without the added complexity of obtaining a patient’s tumor tissue sample or building an individualized panel,” said Dr. Anne-Renee Hartman, Chief Medical Officer of Adela. “For patients with head and neck cancer, in particular, tumor tissue samples are often not available. A blood-only, tissue-agnostic offering such as Adela’s is the only way to make MRD testing universally accessible to those who will benefit.”

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“These strong validation results exemplify the ability of Adela’s genome-wide methylome enrichment platform to maximize detection of cancer signal in the blood by efficiently capturing and preserving the information-rich methylated regions of the genome. This single liquid biopsy platform can be applied across cancer types, and we look forward to replicating these promising results in additional cancer types in the near future,” said Dr. Daniel De Carvalho, Chief Scientific Officer of Adela and Senior Scientist at Princess Margaret Cancer Centre, University Health Network.

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A Research Use Only (RUO) version of Adela’s MRD test is currently available to biopharmaceutical companies and other investigators for use in biomarker discovery and drug development. Adela plans to commercialize the test in 2025 for use in patients who have received curative intent treatment for head & neck cancer, regardless of HPV status, to detect recurrence earlier and help guide treatment decision-making.

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Presentation Details

Presentation Number 64O - Clinical validation of a tissue-agnostic genome-wide methylome enrichment MRD assay for head and neck cancers

Shao Hui Huang, MD, MSc, MRT(T) 3

Saturday September 14, 2024 15:35 PM CEST

Salamanca Auditorium, Hall 5