Enhanced detection of head and neck cancer recurrence using automated EV isolation and vibrational spectroscopy

Who could benefit from this research

What this research studies

This project aims to create a fully automated, high-throughput test that isolates extracellular vesicles from plasma or saliva and uses vibrational spectroscopy to detect recurrent head and neck cancer at earlier, more treatable stages. The plan includes integrating EV isolation and spectral analysis into a robotic platform with rigorous design controls and a quality management system aligned with CLIA and future FDA requirements. In Phase II, the test’s clinical performance will be validated in a longitudinal patient cohort, and a machine-learning classifier will be refined to support potential LDT submission. If successful, this tool could enable timely, cost-effective monitoring across diverse head and neck cancer subtypes, helping clinicians make better-informed treatment decisions.

Why it matters

Where this research is happening

• Illumifydx, INC.
  Broomfield, United States Active

Researchers

• Principal investigator: Navas-Moreno, Maria — Illumifydx, INC.
• Study coordinator: Navas-Moreno, Maria

Related research

Other NIH-funded projects on the same topics.

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• Using imaging and RNA analysis to predict cancer recurrence in the head and neck

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  NIH research Washington University · Saint Louis, United States · NIH-10909477

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• Biomarker to guide treatment in head and neck cancer

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  NIH research Boston University (Charles River Campus) · Boston, United States · NIH-11580855

About this research

1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.