A University of Pittsburgh researcher is developing a device and associated analytical method to enable the detection of Human papillomavirus-positive (HPV+) throat cancers. These cancers are known to occur deep in the tonsils in the tonsillar crypts, or at the base of the tongue, often requiring invasive surgery to detect and diagnose. This novel device is designed to irrigate lesions and extract cell-free DNA (cfDNA). Using next-generation sequencing (NGS), cfDNA could be analyzed to assess the risk of HPV+ cancers in a non-invasive manner, improving long-term outcomes in patients, and potentially leading to a universal screening program
Description
HPV is a group of more than 200 related viruses with some linked to several cancers including as much as 70% of oropharyngeal cancers. Early warning signs can include lesions in the oral cavity, but a biopsy is needed for a complete diagnosis of any cancer which can be painful and invasive requiring the expertise of ENT or oral surgeons. This novel approach is two-pronged. Firstly, using a device, forceful irrigation of suspicious lesions can lead to the collection of a liquid biopsy in a non-invasive manner. Secondly, this liquid biopsy can be analyzed for cfDNA and cytology to identify biomarkers of HPV+ cancers and detect lesions most likely to be cancerous. Further surgical biopsies can be selectively performed on these lesions for more in-depth diagnosis. This novel device and liquid biopsy could aid diagnosis of oropharyngeal cancers reducing the need for unnecessary surgical intervention in patients with low-risk lesions.
Applications
- Throat cancer
- Head and neck squamous cell carcinoma (HNSCC)
- Other HPV+ oropharyngeal cancers
Advantages
In recent years, HPV vaccines and pap smears have reduced the rates of genital HPV+ cancers. However, no screening technique exists for HPV+ oral cancers. Many HPV+ cancers initially present as microscopic tumors in the crypts of the tonsils and base of the tongue, but currently, there is no method to identify these cancers from mucosal surfaces resulting in patients presenting with advanced metastasis. Diagnosis of these microscopic cancers requires exploratory surgery and biopsy, with a risk of side effects including infection, bleeding or damage to teeth.
A non-invasive screening or a risk stratification tool would reduce the need for unnecessary biopsies and associated risks. Designed as a closed-circuit device applied directly to the base of the tongue, tonsils, or area of interest, lesions can be forcibly irrigated resulting in gentle disruption of the lesion surface and subsequent collection of a liquid biopsy. This liquid biopsy could be assessed for biomarkers of HPV+ cancers including analysis of cfDNA using NGS techniques.
Since HPV driven cancers of the head and neck occur deep in the crypts, they cannot be visualized until later stages. Brushes or swabs of the overlying mucosal surface would not detect, and patients are most often asymptomatic. There are emerging blood tests that can in theory predict HPV associated cancers years before the cancer is detectable clinically, but these test are limited by a lack of actionability. Even if you know the patient has a microscopic cancer, it is impossible to find in the crypts without a very extensive, unacceptable surgery. In patients with a high-risk blood test, the device would allow a non-invasive way of identifying the region of the oropharynx at risk and treat with a targeted surgical resection.
Invention Readiness
Currently in the concept phase. This device will contain a flexible cone to be placed directly over areas of interest. Using irrigation and suction the surface of lesions will be agitated, releasing cfDNA for analysis and lesion cells for cytology, to stratify the risk of HPV+ cancers and aid clinical decision making, including the need for surgical biopsy.
IP Status
Patent Pending
