Naveris to Present New Data Highlighting Clinical Utility of the NavDx® Test at the 2024 ASCO Annual Meeting

WALTHAM, Mass.--(BUSINESS WIRE)-- Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced new data to be presented at The American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from May 31 – June 2, 2024. These presentations underscore Naveris’ continued innovation with the NavDx test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV^®)-HPV DNA blood test aiding in the detection and management of HPV-driven cancers.

“ASCO provides an unparalleled platform to showcase the versatility and clinical value of NavDx across various stages of cancer management from early detection to post-treatment surveillance,” said Barry M. Berger, MD, Chief Medical Officer at Naveris. “We are pleased to present new data highlighting the high predictive value of TTMV-HPV DNA and its utility in monitoring disease status during treatment. These results demonstrate how NavDx is transforming the care landscape for patients with HPV-driven cancers.”

These presentations also highlight Naveris’ on-going commitment to patient-centered innovation and collaboration with stakeholders across the cancer care ecosystem. Lillian Kreppel, Co-Founder and Executive Director of the HPV Cancers Alliance, commented, “The HPV Cancers Alliance celebrates the innovation of tests that can more accurately detect a recurrence of cancer before it is found through a visual exam. This can result in more informed patients, an earlier indication of possible recurrence, more targeted care options for patients, and ultimately more lives saved. The HPV Cancers Alliance desires the best quality of life and outcomes possible for all cancer survivors and their families.”

The presentations at ASCO will report on the efficacy of Naveris’ circulating tumor HPV DNA-based approach for monitoring disease status, predicting recurrence, and guiding therapy in HPV-driven cancers:

• Poster Presentation | Abstract #6066
  Presenter: Krzysztof Misiukiewicz, MD, Icahn School of Medicine at Mount Sinai
  Can TTMV clearance predict recurrence in HPV HNSCC?

  This study evaluates the predictive value of TTMV-HPV DNA in patients with locally advanced HPV-positive head and neck squamous cell carcinoma (HNSCC). Patients with rapid clearance of TTMV after induction chemotherapy (IC) remained disease-free, while 27% of those with persistent TTMV experienced relapses. The negative predictive value (NPV) of TTMV was 100%, and the positive predictive value (PPV) was 96%, supporting its use in guiding treatment intensity and surveillance.

• Poster Presentation | Abstract #6067
  Presenter: Krzysztof Misiukiewicz, MD, Icahn School of Medicine at Mount Sinai
  TTMV and association with relapse in patients with HPV-related SCCHN undergoing CRT

  This study explores the use of TTMV-HPV DNA to monitor disease status in patients with HPV-related squamous cell carcinoma of the head and neck (SCCHN) undergoing chemoradiation therapy (CRT). TTMV can identify recurrence or persistence and can synergize with PET to guide therapy, as all 3 post-CRT recurrences were detected using TTMV and confirmed with PET and biopsy. The combination of TTMV with PET enhances response assessment and helps guide treatment strategies.

• Poster Presentation | Abstract #TPS6119
  Presenter: James Edward Bates, MD, Emory University
  Biomarker-driven radiation therapy dose reduction after transoral robotic surgery for the treatment of HPV-positive oropharyngeal cancer

  This trials in progress abstract highlights an ongoing multi-institutional phase II trial evaluating the efficacy of reducing radiation therapy doses based on biomarker data post-transoral robotic surgery for HPV-positive oropharyngeal cancer. Patients with undetectable post-operative TTMV-HPV DNA without high-risk pathologic factors undergo de-escalation of adjuvant radiation therapy to 36 Gy, aiming to improve long-term swallowing function.

• Publication Only | Abstract #e15045
  Presenter: Scott Roof, MD, Icahn School of Medicine at Mount Sinai
  The NAVigate-HPV Registry: A comprehensive biomarker evidence base for HPV-driven cancers

  This abstract outlines the structure and objectives of the recently launched NAVigate-HPV Registry, emphasizing its role in establishing a robust evidence base for the clinical utility of circulating tumor HPV DNA in managing HPV-driven cancers. The registry will systematically collect and analyze integrated biomarker and clinical data from various US cancer centers. The registry brings together representatives from 14 geographically diverse sites, expected to include over 1,000 patients within one year and grow to over 5,000 within five years.

• Publication Only | Abstract #e18032
  Presenter: Olga Russial, MD, Thomas Jefferson University Hospital
  Clinical utility of circulating tumor tissue-modified viral HPV DNA testing in HPV-driven oropharyngeal cancer arising in women

  This study evaluates the clinical utility of TTMV-HPV DNA testing in women with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). This is the first single institutional report evaluating the clinical utility of TTMV-HPV DNA in a female cohort treated for HPV+ OPSCC. Utilization of this testing in a female population appears feasible in a community-based hospital setting. All patients had TTMV resolution after treatment and remained undetectable without recurrence.

Naveris and the NavDx test will be on exhibit at ASCO 2024 at Booth #31142. More information can be found on the ASCO website here.

About Naveris

Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com. NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).

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