Human Papillomavirus-Related Anal Squamous Cell Carcinoma

Data presented showcases clinical utility of NavDx for patients with HPV-driven anal cancer WALTHAM, Mass.--(BUSINESS WIRE)-- Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, announced new data at EUROGIN International Multidisciplinary HPV Congress 2024, taking place in Stockholm on March 13-16. NavDx is the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer. 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, leading to recent positive Medicare and commercial insurance coverage policies. "We are glad to be presenting our latest findings at EUROGIN, including the first study highlighting the utility of NavDx in the surveillance of patients, post-treatment, for recurrent anal cancer,” said Barry M. Berger, MD, Chief Medical Officer at Naveris. "The research we and our partners have the opportunity to share at this conference showcases the clinical significance of the NavDx test in the detection and surveillance of multiple types of HPV-driven cancers, building on the body of evidence supporting its use at every stage of these viral driven cancers.” "Our study marks a significant advancement in the surveillance of anal squamous cell carcinoma, demonstrating that circulating TTMV-HPV DNA significantly enhances early detection of recurrence, giving patients battling HPV-driven cancers a chance for better outcomes,” said Shane Lloyd, MD, Associate Professor of Radiation Oncology at University of Utah School of Medicine and Huntsman Cancer Institute, and the presenting author for the study. “This precision medicine approach, leveraging advanced molecular diagnostics, could enable more prompt and individualized treatments." Following are oral presentations from Naveris and its partners at EUROGIN 2024 showcasing the clinical utility of NavDx for patients with HPV-driven anal cancer: FC 07-9: Detection of patients with recurrent HPV-driven anal cancer using circulating tumor HPV DNA Presenting Author: Shane Lloyd, MD; University of Utah School of Medicine and Huntsman Cancer Institute Session, Date/Time: Anus – Free Communications | March 13, 2024 | 1:45PM – 3:25PM CET Results were presented from the first multi-institutional analysis of the NavDx test ordered during routine clinical practice for the post-treatment surveillance of patients with HPV-driven anal squamous cell carcinoma (ASCC). The test showed high positive and negative predictive values of 100% and 98.6%, respectively, when ordered through routine clinical use in this cohort of 33 patients, comparable to its use in HPV-driven oropharyngeal cancer. Positive NavDx test results successfully pinpointed patients with recurrences in all cases, highlighting the test's utility as a potent surveillance tool in daily clinical practice for early detection of recurrence. FC 07-12: Circulating tumor tissue modified viral-human papillomavirus DNA (TTMV-HPV DNA) is a biomarker of response to pembrolizumab in anal cancer Presenting Author: Brandon Huffman, MD; Dana-Farber Cancer Institute at Harvard Medical School Session, Date/Time: Anus – Free Communications| March 13, 2024 | 1:45PM – 3:25PM CET Results were presented from a phase II clinical trial involving 32 patients with advanced anal cancer treated with pembrolizumab. This study explored NavDx as a potential biomarker for monitoring disease response. Initial findings indicate baseline sensitivity and specificity of 95% and 100%, respectively. The study additionally found that pre-treatment NavDx levels were indicative of tumor burden in the recurrent and metastatic setting and that changes in these levels were significantly associated with clinical outcomes. Together this highlights the utility of NavDx as a dynamic tool for early assessment of therapeutic response. Additional updates will be presented as part of the EUROGIN 2024 HPV and Head & Neck Cancer Forum: HN05-2: DART 2.0 (Mayo) Presenting Author: Daniel Ma, MD; Mayo Clinic Session, Date/Time: HN – HPV and Head & Neck Forum, Management | March 15, 2024 | 10:00AM – 11:30AM CET Details of the trial design from the ongoing DART 2.0 trial will be shared (NCT05541016). The DART 2.0 trial evaluates the ability of NavDx to improve treatment intensity selection in patients with HPV-driven head and neck cancer to best balance the side effects of treatment with decreasing cancer recurrence. DART 2.0 builds upon the results of the previously reported phase III MC1675 DART clinical trial, where post-treatment detectability of NavDx was a significant risk factor for cancer recurrence in patients with head and neck cancer. HN 07-3: TTMV-HPV DNA for surveillance in the clinic Presenting Author: Eleni Rettig, MD, FACS; Brigham and Women's Hospital and Dana-Farber Cancer Institute at Harvard Medical School Session, Date/Time: HN – HPV and Head & Neck Forum, Molecular Diagnosis and Surveillance | March 15, 2024 | 2:30PM – 4:00PM CET Early insights will be shared from the first prospective cohort study examining biomarker-led monitoring for early detection of recurrent HPV-positive oropharyngeal cancer (OPC) (NCT04965792). The study involved 150 patients, with NavDx tested pre-treatment and every three months post-treatment and patients followed for five years. 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 and . NavDx has not been cleared or approved by the US Food and Drug Administration (FDA). View source version on businesswire.com: Contacts Megan Kernan ICR Westwicke Healthcare PR Tel: 646.677.1870 Megan.Kernan@icrinc.com Source: Naveris, Inc. View this news release online at:

Human Papillomavirus (HPV) infection is a prevalent health concern worldwide, with approximately 12,000 women diagnosed with cervical cancer and 4,000 losing their lives to this disease annually, according to the World Health Organization (WHO). To combat this public health issue, various diagnostic methods and tests have been developed to identify HPV deadly infection and associated diseases. The epidemiology study plays a pivotal role in early detection and management of HPV-related diseases, particularly cervical cancer, with the potential for highly successful treatment outcomes when identified in their initial stages. Regulatory screenings and medical consultations are vital for individuals at risk, contributing to improved public health outcomes in the fight against HPV-related diseases. LONDON, Sept. 14, 2023 /PRNewswire/ -- Human Papillomavirus (HPV) is a widespread viral infection that affects millions of people worldwide. As a market researcher, it's crucial to delve into the multifaceted aspects of HPV, including disease overview, diagnostic analysis, prevention strategies, treatment gaps identification, market trends, competitive landscape, regulatory framework, and clinical trial assessments. HPV Disease Overview HPV is a group of viruses that infect the epithelial cells of the skin and mucous membranes. Major question is: Is HPV contagious? It is the most common sexually transmitted infection globally. HPV infections are categorized into low-risk and high-risk types, with the latter being associated with various cancers, including cervical, anal, oropharyngeal, throat cancer, and penile cancer. Diagnostic Analysis Accurate diagnosis is pivotal for managing HPV-related conditions. Diagnostic methods include: Physical Assessment: Healthcare providers visually inspect genital and anal areas for anal HPV-related warts or lesions. In women, a colposcopy closely examines the cervix, vagina, or vulva with a special instrument. Pap Smear Test: The Pap smear is the gold standard for cervical cancer screening. It detects abnormal cervical cells caused by HPV. HPV Genotyping: This test identifies the presence of high-risk HPV types, aiding in early detection of potential cancer risks. Biopsy: When abnormal cells are found, a biopsy is performed to confirm the diagnosis and assess the extent of tissue changes. Imaging Studies: Advanced HPV-related cancers require CT scans, MRI scans, or PET scans for assessing disease and planning treatment. Price and Market Access Some of the major Diagnostics market players are: Prevention Prevention remains the most effective strategy against HPV: Vaccination: HPV vaccines such as Gardasil and Cervarix are available to prevent infection with the most common cancer-causing HPV types. Safe Sexual Practices: Encouraging condom use and reducing the number of sexual partners can lower the risk of transmission. Regular Screenings: Routine screenings, especially for high-risk groups, can detect HPV-related conditions at an early, treatable stage. Learn More About the FDA NDA & BLA Approval (NME) Drugs for HPV Disease @ Treatment Analysis There is no cure for HPV itself, but treatments focus on managing related conditions: Cryotherapy: Freezing abnormal cells is a common treatment for genital warts caused by HPV. Surgery: In cases of cancer or severe dysplasia, surgical procedures like conization or excision may be necessary. Medications: Antiviral medications and topical creams are prescribed to manage HPV symptoms in mouth. Market Trends Analysis The HPV pricing and market access is dynamic and influenced by several trends: Rising Vaccination Rates: Increased awareness and government initiatives have boosted HPV vaccination rates, reducing the incidence of related cancers. Technological Advancements: Advances in diagnostic tools, like DNA male HPV test, have improved accuracy and early detection. Targeted Therapies: Research is ongoing to develop targeted therapies for HPV-related cancers, offering hope for improved treatment outcomes. Competitive Analysis The HPV market has several key players, including pharmaceutical companies, diagnostic test providers, and vaccine manufacturers. Intense competition in vaccine development and diagnostic accuracy and players coming up with drug launch strategies is driving innovation in this sector. Notable companies include: GlaxoSmithKline (GSK) CryoPen, Inc Merck & Co., Inc Merck & Co., Inc Taro Pharmaceuticals Wartner Cryotherapy TOLMAR Pharmaceuticals, Inc. GlaxoSmithKline (GSK) Valeant Pharmaceuticals (now Bausch Health Companies Inc.) Cryoalfa by Cryoalfa S.r.l Verrica Pharmaceuticals Inc. Pfizer Medimetriks Pharmaceuticals OraSure Technologies Others Discover More About Pricing and Reimbursement, Epidemiology Study, and Healthcare @ Regulatory Framework Analysis Regulations surrounding HPV diagnostics and vaccines vary by country. Many governments have implemented vaccination programs for adolescents, while healthcare guidelines often dictate screening and treatment protocols. Staying compliant with local regulations is crucial for market players. Clinical Assessment Ongoing clinical trial feasibility analysis are essential for advancing HPV-related research and treatment options. These trials assess the safety and efficacy of new vaccines, therapies, and diagnostic tools. They play a critical role in shaping the future of HPV clinical trial management. Unlock the Benefits Today! Get Started Now and Elevate Your Experience @ Conclusion Human Papillomavirus can cause cancer and continues to pose significant public health challenges globally. As a healthcare consulting services provider, DLI understands the disease burden, intricacies, diagnostic methods, prevention strategies, treatment options, market trends, competition, regulatory consulting, and clinical developments is vital for providing valuable insights to stakeholders. The evolving landscape of HPV management offers both challenges and opportunities for healthcare professionals, researchers, and companies invested in combating this pervasive virus. 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Utilizing the power of data analytics, Disease Landscape Insights is dedicated to healthcare sector with invaluable, finely crafted insights and recommendations regarding global pricing and market access strategies. As a specialized firm, we are committed to delivering unparalleled insights into pricing and market access, custom-tailored to the healthcare and pharmaceutical industries. Our data-driven solutions and cutting-edge technology position us as your trustworthy partner, offering swift, adaptable, and evidence-based alternatives to traditional market access and pricing research methods.  Our core competencies encompass Market Research Services, Consulting Services, Global Pricing and Market Access, Epidemiology Studies, as well as Product Portfolio and Pipeline Services. 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