Non-invasive Liquid Biopsy Assay for Early Detection of HPV-Associated Cancers

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SUMMARY OF INVENTION

Human papillomavirus (HPV) is the etiological agent of squamous cell carcinomas arising in the oropharynx, cervix, vulva, vagina, anal canal, and penis, which together constitute 4.5% of all cancers worldwide. Pelvic exams and Papanicolaou (Pap) smears are used for the early detection of HPV-associated cervical cancer, but there are no effective screening approaches to detect early lesions arising at other sites. MSK investigators have developed a highly accurate liquid biopsy assay for identifying early-stage HPV-associated oral and anal cancers. 

Using a digital droplet polymerase chain reaction (ddPCR) assay, the researchers can detect DNA from HPV 16 and HPV 33 in circulating tumor DNA (ctDNA) from plasma samples of patients. The assay has an overall sensitivity of 96% and specificity of 100%. The assay was robust at detecting HPV ctDNA even in patients with low-volume tumors who recently had undergone surgical resection. In addition, ctDNA levels detected using this assay was tightly correlated with tumor shrinkage after treatment, further demonstrating the specificity of the assay as well as utility of the assay in monitoring response to therapy. Significantly, the assay is able to detect both European and non-European variants of HPV 16, indicating universality of use. 

ADVANTAGES

  • High sensitivity and specificity. Outperforms other HPV DNA detection platforms, including the Roche Cobas HPV Test and quantitative PCR by 16- and 5-fold, respectively
  • Minimally invasive method can be used for early detection and to monitor response to therapy during and after treatment of HPV+ tumors 
  • Easily adaptable to detect other high-risk HPV strains 

MARKET OPPORTUNITY

Each year in the US, there are nearly 36,000 new cases of HPV-associated cancers, including 11,000 (about one-third) cases of cervical cancer, roughly 14,000 cases of oropharyngeal cancer, and 6,500 cases of anal cancer. HPV 16 and HPV 33 are the two most common subtypes of HPV and account for more than 95% of all HPV+ oropharyngeal and anal cancers.

PATENT INFORMATION

  • PCT application PCT/US2019/050365 (published) for early detection of HPV-associated cancers

LEAD INVESTIGATORS

  • Daniel Higginson, MD. Radiation Oncologist, Memorial Hospital, MSK

PUBLICATION

  • Rama Damerla et al., (2019) Detection of Early Human Papillomavirus-Associated Cancers by Liquid Biopsy. JCO Precis Oncol. 2019;3:10.120 (Pubmed link)

CONTACT INFORMATION

Kannan Krishnamurthy, PhD

Associate Director, Business Development & Licensing; Tel: 646-888-1075; email: krishnak@mskcc.org

Stage of Development

Ready to use