Government Owned Invention Available for License: Method of Detecting Circulating Cell-Free HPV 6 and 11 DNA in Patients Afflicted With Diseases Caused by Chronic HPV 6 or 11 Infection and Use Thereof

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services National Institutes of Health AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: The National Cancer Institute (NCI) and Frederick National Laboratory for Cancer Research (FNLCR) seek research co-development partners and/or licensees for commercial development of a novel liquid biopsy diagnostic for non-invasive detection of cell-free HPV 6 and 11 DNA for recurrent respiratory papillomatosis (RRP). FOR FURTHER INFORMATION CONTACT: Inquiries related to this license opportunity should be directed to: Suna Gulay French, Ph.D., Technology Transfer Manager, NCI, Technology Transfer Center, Email: suna.gulay@nih.gov or Phone: 240-276-7424. SUPPLEMENTARY INFORMATION: RRP, caused by chronic infection with human papillomavirus (HPV) types 6 and 11, is a rare but potentially fatal disease characterized by the growth of papillomas throughout the respiratory tract. While HPV 6/11 infections are common, affecting approximately 40% of U.S. adults, a subset of patients can develop a range of conditions from benign papillomas to dysplasia and invasive cancers. Current treatment for RRP typically involves repetitive surgical intervention or laser ablation to alleviate symptoms, which carries significant procedural risks. A recent breakthrough with a therapeutic HPV vaccine demonstrated that 51% of patients avoided surgery for at least a year, with some experiencing durable remission. However, there remains no reliable diagnostic tool t…