Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making

Overview

The OncAlert Oral Cancer RAPID Test (OncAlert RAPID) is a qualitative point-of-care lateral
flow assay to aid in the decision to biopsy in patients with clinical features associated
with oral potentially malignant disorders and or oral/oropharyngeal cancer (i.e. head and
neck squamous cell carcinoma).

Proposed Intended Use Statement

The device measures soluble CD44 and total protein in saliva samples collected in saline. The
test is an adjunct to the biopsy decision process, and not intended as a screening or
stand-alone diagnostic assay. To be used in adults 23 years and older. Not intended for use
in pregnant women.

STUDY OBJECTIVES

The principal objectives of this study are to:

- Validate the OncAlert RAPID Test, with an NPV ≥ (1-prevalence),

- Evaluate OncAlert RAPID Test results in patients without immediate biopsy, both at
baseline and scheduled follow-up visit (approximately 1-3 months), to assess impact on
outcome,

- Evaluate the independent and associated contribution of readily available clinical
variables including age, race, gender, HPV status, socioeconomic level, tobacco, and
alcohol use with the biopsy and test results.

STUDY OVERVIEW

Study Approach

Prospectively collect 5cc of normal saline after a combination of swish, gargle and spit into
the provided collection specimen cup. 1cc will be removed and sequestered for subsequent
downstream analyses (Section 7). Specimens will be collected at baseline (time of biopsy) as
per standard practice at each site. The OncAlert RAPID Test cassette is inserted into the
specimen cup and read directly from the cassette in 10 minutes. In addition, acquire
comprehensive clinical - pathology and patient demographic features including age, gender,
race, ethnicity, and all pathology biopsy results. Also, obtain any pertinent additional
clinical data including HPV status, socioeconomic status, smoking, drinking history, and
pertinent features related to oral health. It is presumed that some patients within the
current biopsy protocol will undergo treatment as a result of the biopsy diagnosis. The
clinical-pathology data, when accessible, for these patients will be collected for subsequent
secondary analyses. A central pathology review for all biopsy results will be performed and
incorporated into the final analyses.

Study Duration

Cohorts 1a and 1b patients will be followed until pathology of clinically directed incisional
/ diagnostic biopsy pathology report is received.

Cohort 2 patients not having an initial incisional / diagnostic biopsy will have an
additional OncAlert RAPID test performed within 1-3 months of initial visit as per clinical
indications and followed as per 7.2.1, specifically if a biopsy is performed.

It is anticipated that the study will continue up to 1.5-years to collect all pertinent
clinical information on enrolled subjects.

Inclusion Criteria:

- 23 years of age or older

- A clinical suspicion of oral potentially malignant disorders, oral or oropharyngeal
cancer, or both based in part on clinical examination, symptoms, clinical history,
suspicious lesion(s) in mouth without history of a prior biopsy.

- The subject must be able to comprehend and sign an approved informed consent form and
other applicable study documents. Patients are eligible regardless of race, gender,
and ethnicity.

Exclusion Criteria:

- Prior history and/or diagnosis of any HN cancer/HNSCC of the oral cavity, oropharynx,
or hypopharynx including nasopharyngeal carcinoma.

- Prior treatment of HN cancer / HNSCC of the oral cavity, oropharynx, or hypopharynx
including nasopharyngeal carcinoma.

- Planned excisional biopsy for a diagnosis of HNSCC

- Clinical presentation without localizing findings

- Prior history of a salivary gland tumor

- Current and or prior diagnosis of cancer (note: other than basal and squamous cell
carcinoma of the skin) within the past 5 years.

- Pregnant