# Validation of a saliva test using methylated microRNAs for head and neck cancer recurrence

> **NIH NIH UH2** · UNIVERSITY OF COLORADO DENVER · 2021 · $273,315

## Abstract

PROJECT SUMMARY
The objective of this combined UH2/UH3 application is to develop a non-invasive, accurate, and cost-effective
saliva-based test for early detection of squamous cell carcinoma of the head and neck (SCCHN) recurrence.
SCCHN includes squamous cell carcinomas derived from oral cavity, tongue, pharynx and larynx. It is the 7th
most common cancer in US and worldwide by incidence, and the 3rd in US and 4th worldwide by 5-year
prevalence. SCCHN is a biologically aggressive cancer in which high rates of recurrence (local, locoregional or
distant) contribute significantly to poor patient survival. Current clinical practice methods for detection of
SCCHN recurrence are either subjective, invasive, hard to access, not able to detect recurrence in a timely
manner or expensive. There is an unmet medical need for an objective, non-invasive, easy to access test that
is able to detect SCCHN recurrence in a timely and a cost-effective way. Our solution is “HNKlear”, a non-
invasive, saliva-based candidate test for early detection of SCCHN recurrence. HNKlear incorporates a 7-
methylated microRNA biomarker panel. The real-time nature of our test will provide more timely and precise
detection of SCCHN recurrence. In our published proof of concept studies, HNKlear demonstrated 92%
sensitivity and 98% specificity in ~300 SCCHN and control tissue samples and 85% sensitivity and 95% in
~200 SCCHN and control saliva samples using continuous variables, which supports the clinical translation of
the test. We propose a combined UH2/UH3 application for the clinical translation of HNKlear. In the UH2
phase, we will analytically validate the test and algorithm in a pre-clinical study and in a new patient cohort.
Success of this phase will let us lock down the test and cut-off when the milestone is met. We will then conduct
a clinical study in the UH3 phase to demonstrate the clinical validity of HNKlear for SCCHN recurrence in an
observational clinical follow-up study incorporating HNKlear into current clinical practice. Success of this phase
will generate robust evidence of the clinical validity of HNKlear for early detection of SCCHN recurrence, and
will further enable clinical application of HNKlear as a Laboratory Developed Test.

## Key facts

- **NIH application ID:** 10281743
- **Project number:** 1UH2CA262045-01
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Shi-Long Lu
- **Activity code:** UH2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $273,315
- **Award type:** 1
- **Project period:** 2021-09-21 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10281743

## Citation

> US National Institutes of Health, RePORTER application 10281743, Validation of a saliva test using methylated microRNAs for head and neck cancer recurrence (1UH2CA262045-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10281743. Licensed CC0.

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