For Release: June 2, 2021

Waltham, MA— A new clinically-validated saliva test has been shown to detect HPV-associated head and neck cancer with high accuracy, a first-of-its-kind study result.

Researchers at Washington University School of Medicine in St. Louis used the Naveris, Inc. test to analyze saliva for sequences of the human papilloma virus (HPV) genome that are specific for HPV DNA released from malignant tumors. The test successfully distinguishes this tumor-tissue modified virus from non-cancerous sources of HPV DNA and precisely measures the number of tumor-tissue modified viral HPV (TTMV-HPV) DNA strands present in a saliva sample.

The study results point to the potential for a significant improvement in early detection of the most common type of head and neck cancer, HPV-associated oropharyngeal squamous cell carcinoma.

“Naveris’ patient-friendly saliva test has the potential to radically advance early detection of HPV-positive head and neck cancer, which has been growing rapidly among men in the United States. Early detection of these cancers would make a dramatic difference in patient outcomes,” said Piyush Gupta, PhD, CEO of Naveris.

The study quantified participants’ tumor-tissue modified viral HPV DNA in saliva samples and compared it to the levels found in their blood by utilizing Naveris’ NavDx® test. The results showed that TTMV-HPV DNA was commonly found in the saliva of HPV-associated head and neck cancer patients (44/46 cases), and at 18 times higher levels in the saliva samples than in the blood samples. One sample had undetectable TTMV-HPV and one was indeterminate for HPV DNA.

Washington University researchers are presenting an abstract (#6063) of the study at the American Society of Clinical Oncology (ASCO) 2021 annual meeting.

“The results of our study highlight the potential of accurately analyzing saliva to improve the early detection of HPV-associated oropharyngeal squamous cell carcinoma. If validated in larger studies, this test could lead to earlier diagnosis and treatment,” said the study’s principal investigator Jose P. Zevallos, MD, chief of the division of Head and Neck Surgery in the Department of Otolaryngology at Washington University School of Medicine.

Naveris’ new saliva test is based upon the proprietary technology employed by the NavDx® blood test that is in use at centers of excellence treating HPV-associated oropharyngeal cancer across the United States. NavDx® is a liquid biopsy test that detects HPV-associated head and neck cancer earlier than is possible with imaging and is provided exclusively in the United States through the Naveris national reference CAP-accredited laboratory.

About Oropharyngeal Cancer:
Oropharyngeal cancer, which can develop at the base of the tongue, tonsils, and the middle part of the throat, used to be closely associated with smoking and heavy drinking. Today, however, oropharyngeal cancer is primarily caused by human papillomavirus (HPV) infection, the most common sexually transmitted virus and infection in the United States. More than one of five U.S. adults are infected with a high-risk strain of HPV that can potentially develop into cancer.

  1. Cases of HPV-positive oropharyngeal cancer have been increasing at an exponential rate among men in the United States over the last two decades
  2.  About 54,000 cases of oropharyngeal and oral cavity cancer are expected in the nation this year and more than 10,000 deaths.
  3. Oropharyngeal cancers usually are not identified early because they grow slowly in locations that are not easy to see. By the time the cancers are recognized they frequently have spread to the lymph nodes and are difficult to treat. Early detection, however, enables highly effective
    treatment.

About Naveris, Inc.
Naveris, Inc. is a molecular diagnostics company developing and commercializing novel blood and saliva tests to enhance the early detection and clinical management of viral-associated cancers. The company’s NavDx ® blood test, which uses proprietary technology to detect tumor tissue modified HPV, is in use at leading cancer treatment centers and academic medical centers throughout the United States.

1 https://www.cdc.gov/nchs/products/databriefs/db280.htm#ref2
2 https://www.nature.com/articles/s41572-020-00224-3#ref-CR34
3 https://www.cancer.org/cancer/oral-cavity-and-oropharyngeal-cancer/about/key-
statistics.html#:~:text=The%20American%20Cancer%20Society's%20most,oral%20cavity%20or%20oropharyngeal
%20cancer.

Contact:
Allan Chernoff
Chernoff Communications
(917) 597-5450
achernoff@ChernoffCommunications.com