News | February 5, 2020

Blood Test Accurately Identifies HPV-Related Head And Neck Cancer Recurrence; Prospective Clinical Study Published In Journal Of Clinical Oncology

WALTHAM, MASS.--(BUSINESS WIRE)--

A novel blood test can detect recurrent Human Papilloma Virus (HPV)-related head and neck (oropharyngeal) cancers, according to a study published online in the Journal of Clinical Oncology by researchers at the University of North Carolina School of Medicine. The multi-year, prospective study underscores the test’s potential to allow patients with recurrent disease to begin earlier treatment and spare disease-free patients from repeated invasive testing.

The technology underlying the research is licensed from the University of North Carolina to Naveris, which has designed and validated NavDx®, a laboratory developed test for cancer-associated HPV detection. NavDx® identifies minute fragments of tumor-modified viral HPV DNA, which is distinct from native viral HPV DNA. The company recently began providing the test through its CLIA laboratory to leading head and neck oncology treatment centers.

“This study shows how an exceptionally accurate, DNA-based blood test can be used to enhance the clinical management of patients with HPV-related cancers,” said Piyush Gupta, PhD, CEO of Naveris. “The test identified all patients who recurred, doing so earlier than the current standard of care for most patients, while all patients that tested negative remained disease free for the duration of the study.”

This study is timely as the incidence of HPV-related head and neck cancer has increased exponentially in recent decades and it is now the most prevalent HPV-related cancer in the United States, surpassing cervical cancer.

The prospective study at UNC was led by Associate Professor Dr. Bhisham Chera and Assistant Professor Dr. Gaorav Gupta. 115 patients treated for HPV-related head and neck cancers, with no evidence of disease post-therapy, were monitored for the development of recurrence for up to 3.5 years with radio-imaging and fiberoptic nasopharyngeal endoscopy. Patients also received the blood test prior to and during treatment, and at post-treatment follow up visits. All patients who eventually developed a recurrence had positive blood tests (sensitivity of 100%), while no patient with a negative blood test developed a recurrence (negative predictive value of 100%). Of the patients with two consecutive positive blood tests, all but one developed a biopsy-proven recurrence (positive predictive value of 94%). A positive blood test preceded the detection of recurrence by imaging for 91% of patients, with a median lead-time of 3.9 months.

The publication, byChera et al., is entitled, Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-associated Oropharyngeal Cancer, and is available Open Access.

About Naveris, Inc.
Naveris, Inc. is a molecular diagnostics company developing and commercializing novel blood tests to enhance the early detection and clinical management of viral-associated cancers. The company has developed the NavDx® test, which uses proprietary technology to detect tumor tissue modified HPV. For additional information, please visit the company’s website https://www.naveris.com.


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