TEST:

NavDx®

"Naveris, Inc...announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for NavDx, the Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer."

"Naveris, Inc...announced new data at EUROGIN International Multidisciplinary HPV Congress 2024, taking place in Stockholm on March 13-16...Data supporting the clinical validity and utility of NavDx have been published in nearly 20 peer-reviewed publications, leading to recent positive Medicare and commercial insurance coverage policies."

At our institution, we are now routinely performing the ct-DNA assay for surveillance of treated HPV-oropharyngeal SCCa. Correlation between clinical, radiological, and biomarker findings are now part of routine discussions during the multidisciplinary tumor boards.ABBREVIATIONS: ct-DNA=circulating tumor deoxyribonucleic acid; HPV=Human Papilloma virus;OPC=Oropharyngeal SCCa=Squamous cell carcinomas; PCR= Polymerase chain reaction.

"Naveris, Inc...announced the launch of the NAVigate-HPV Registry. This innovative initiative will refine and expand the applications of the NavDx® test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test."

"Naveris, Inc...announced new data to be presented at The American Society for Radiation Oncology (ASTRO) Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Phoenix, AZ from February 29 – March 2, 2024....The test provides a non-invasive and precise method for identifying HPV-driven cancers before there is clinical or radiographical evidence of disease. Data supporting the clinical validity and utility of NavDx have been published in nearly 20 peer-reviewed publications."

"Naveris, Inc...today announced that Highmark Inc. (Highmark), an independent licensee of the Blue Cross Blue Shield Association, now offers coverage for NavDx, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV)-HPV DNA...NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. It provides a non-invasive and precise method for identifying HPV-driven cancers before there is clinical or radiographical evidence of disease....'Receiving coverage from a payor that serves millions of patients is a meaningful step forward as we work to further expand access to NavDx.'"

Our pilot study approach of using HPV ctDNA based selection of patients for post-operative active surveillance resulted in a high rate of gross disease recurrence and failed to meet our primary endpoint. Radiographic recurrence was not preceded by detectable TTMV-HPV DNA during 3 mo interval surveillance, and additional clinical factors are needed to select patients for active surveillance and initiation of delayed adjuvant therapy prior to recurrence.

This study demonstrates that circulating tumor-specific HPV DNA is a sensitive and specific marker for the detection of cervical cancer, with scores dynamically corresponding to treatment response. This biomarker has the potential to serve an unmet need in the management of these cancers. The current study is ongoing with additional patients enrolling and further HPV subtypes being analyzed.

P2; Initiation date: Sep 2023 --> Jan 2024

"Naveris, Inc...announced that Palmetto GBA, the Medicare Administrative Contractor that administers the Molecular Diagnostics Services program (MolDX®), established Medicare coverage for NavDx®, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV®)-HPV DNA. NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. NavDx provides a non-invasive and precise method for monitoring minimal residual disease (MRD) in HPV-driven cancers before there is clinical or radiographical evidence of recurrence."

P2; N=77 --> 30 | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025

"Naveris, Inc...announced the publication of two new peer-review studies in the journals Clinical Cancer Research (CCR) and JAMA Otolaryngology-Head & Neck Surgery (JAMA Head & Neck), which highlight the clinical utility of the company’s tumor tissue modified viral (TTMV®) DNA platform and add to a growing library of data supporting use of the company’s NavDx® blood test."

"Naveris, Inc...announced that the company will be attending The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) 2023 Annual Meeting in Nashville, Tenn., from September 30-October 4 and The American Society for Radiation Oncology (ASTRO) 2023 Annual Meeting in San Diego, Calif., from October 1-4...Naveris will be exhibiting at both meetings, providing the latest information on NavDx®, Naveris’ proprietary flagship blood test for tumor tissue modified viral (TTMV®)-HPV DNA."

P2; N=90; Not yet recruiting; Sponsor:University of Virginia

"In a paper published in JAMA Otolaryngology–Head & Neck Surgery...a team led by researchers at the Icahn School of Medicine at Mount Sinai evaluated the accuracy of the DNA blood test, NavDx, which was developed by Naveris. The test quantifies fragments of circulating tumor tissue-modified viral (TTMV) HPV DNA that is shed into the blood by cancer cells."

"However, the sensitivity was 91.5% for the diagnosis cohort and 88.4% for the surveillance cohort, signifying that nearly 1 in 10 negative tests among patients with HPV-associated OPSCC was a false negative. Additional research is required to validate the assay's performance and, if validated, then further research into the implementation of this assay into standard clinical practice guidelines will be required."

Increased HPV16 signal detection using the CHAMP-16 assay suggests the potential for detection of recurrences significantly earlier than with conventional ddPCR assays in patients with HPV16+ OPSCC. Critically, this multi-probe approach maintains the cost-benefit advantage of ddPCR over next generation sequencing (NGS) approaches, supporting the cost-effectiveness of this assay for both large population screening and routine post-treatment surveillance.

P=N/A; Trial completion date: Mar 2028 --> Mar 2031 | Trial primary completion date: Mar 2028 --> Mar 2031

The commercially available NavDx TTMV-HPV DNA assay demonstrated 100% specificity, and therefore excellent positive predictive value, in both diagnosis and surveillance. However, the sensitivity was lower, 91.5% for the diagnosis cohort and 79.2% for the surveillance cohort, signifying that a negative value may require further work-up. Further studies will be required to determine the optimal timing of testing and how results should inform treatment decisions.

Implementing NavDx for HPV + OPSCC surveillance would benefit patients by reducing costs and unnecessary diagnostic testing.

P=N/A; N=600; Recruiting; Sponsor:Memorial Sloan Kettering Cancer Center

"Naveris, Inc...announced the launch of the DART 2.0 prospective clinical trial (NCT05541016) by Mayo Clinic. The DART 2.0 trial will evaluate the ability of NavDx, Naveris’ flagship blood test for tumor tissue modified viral (TTMV)-HPV DNA, to improve treatment selection in patients with HPV-driven head and neck cancer. NavDx provides a non-invasive and precise method for monitoring molecular residual disease (MRD) and recurrence by analyzing tumor-derived viral DNA in patients' blood samples."

Our findings further support the clinical potential of monitoring circulating TTMV-HPV DNA during post-treatment surveillance. We demonstrate a very high assay NPV correlated with physician-reported outcomes. TTMV-HPV DNA can be used to assist in surveillance and could inform imaging needs and future practice guidelines for HPV-driven head and neck cancer survivors.

Regression analysis revealed a high degree of correlation between expected and effective concentrations, demonstrating excellent linearity (R = 1) across a broad range of analyte concentrations. These results demonstrate that NavDx accurately and reproducibly detects circulating TTMV-HPV DNA, which has been shown to aid in the diagnosis and surveillance of HPV-driven cancers.

P2; Not yet recruiting --> Recruiting

P2; N=45 --> 77

P=N/A; N=100; Recruiting; Sponsor:Northwell Health

"Naveris, Inc...announced that the company and the principle investigator at Mayo Clinic will present its award-winning abstract at the American Society for Radiation Oncology (ASTRO) Annual Meeting held October 23-26, 2022. This presentation describes significant new data supporting the clinical value of NavDx®, the first and only clinically validated circulating tumor-tissue-modified HPV (TTMV®) DNA blood test, as a non-invasive blood test to assess the risk of disease recurrence after treatment in patients with human papilloma virus (HPV)-driven head and neck cancer."

"Naveris, Inc...announced a $33.4 million expansion of its Series A financing, bringing the total investment in Naveris to $51 million. The financing was led by Gurnet Point Capital, joined by TechU Ventures and BrightEdge, the impact and venture capital arm of the American Cancer Society."

P2; N=320; Not yet recruiting; Sponsor:Mayo Clinic

P2; N=145 --> 75

"Naveris, Inc. announces the presentation of an abstract related to its flagship diagnostic test for TTMV-HPV DNA (NavDx) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from June 3 through June 7, 2022 in Chicago and virtually. Results of TTMV-HPV DNA testing in the NRG-HN002 phase II clinical trial for patients with p16-positive oropharynx cancer treated with intensity-modulated radiation therapy (IMRT), with or without cisplatin chemotherapy, will be shared in the presentation."

These findings highlight the clinical potential for circulating TTMV-HPV DNA testing in routine practice. As a surveillance tool, TTMV-HPV DNA positivity was the first indication of recurrence in the majority of cases, pre-dating identification by routine clinical and imaging exams. These data may inform future clinical and guideline-endorsed strategies for HPV-driven malignancy surveillance.

P2; Withheld --> Recruiting

"Naveris, Inc...announced the presentation of significant new data at the plenary session of the ASTRO 2022 Multidisciplinary Head and Neck Cancers Symposium supporting the clinical value of its flagship diagnostic test, NavDx®...A positive NavDx test, which measures tumor tissue modified viral HPV DNA ('TTMV-HPV DNA'), was the first indication of recurrence in 72% of these patients, previously considered to be disease-free, in which imaging and/or biopsy subsequent to the positive NavDx test confirmed the presence of recurrence."

"Sprinter Health…announced a collaboration with Naveris, a molecular diagnostics company dedicated to improving patient care through early detection of virus-related cancers…The partnership will improve the detection, treatment, and clinical management of HPV-driven cancers, such as head and neck cancers, by augmenting the convenience of Naveris’ lead product, NavDx®, which requires regular blood draws."

"These findings demonstrate the clinical validity and utility of circulating TTMV-HPV DNA testing in daily clinical practice as an effective surveillance tool for identifying patients with active and occult recurrent HPV-driven OPSCC. To date the positive predictive value for recurrence or persistence of HPV-driven OPSCC is 95.0% (76/80), which may increase with additional follow-up of cases remaining in active surveillance. Notably, the presence of circulating TTMV-HPV DNA was the first indication of recurrence for 72.4% of cases."

FL remained a part of our proposed surveillance strategy (Strategy B) despite its low estimated efficiency because of its utility in reassuring patients, identifying thrush and infection, and diagnosing radiation necrosis and aspiration. Implementing this novel tumor-specific HPV DNA assay according to our proposed scheduling would lower costs by omitting imaging and better guiding clinical decisions in HPV+OPSCC surveillance by providing high sensitivity and specificity in recurrence detection.