Molecular diagnostics firm Trovagene and India’s Strand Life Sciences inked a memorandum of understanding for a license and validation agreement through which Strand will evaluate Trovagene’s human papillomavirus (HPV) urine test and high-risk HPV DNA assay for clinical diagnostic and carrier screening applications in India and countries in the South Asian Association for Regional Cooperation.
Strand plans to establish the HPV assay technology in its molecular diagnostic laboratory and carry out analytical and clinical validation studies in its target markets. Validation studies will include evaluating the diagnostic accuracy of urine as a specimen for HPV testing at different stages of disease progression, compared with standard cytology, Pap staining, and available molecular tests for the detection of HPV DNA from cervical smears. The firm also plans to validate the clinical utility of HPV DNA testing as a risk indicator and pathological cause of oral cancer in buccal swabs, biopsies, and saliva/sputum specimens.
Strand believes the test has the potential to make HPV screening broadly available In India and South Asia, and to become a new standard of care. “The potential to use urine, an easily obtained and stable testing sample, for high-risk HPV carrier screening across medically underserved areas is very promising,” remarks Vijay Chandru, Ph.D., chairman and CEO.
Trovagene is developing molecular diagnostic tests based on the identification of DNA found in urine. The resulting transrenal DNA tests are based upon a simple method of DNA isolation, followed by detection of DNA fragments bearing specific genetic markers. Trovagene is initially focused on developing tests in fields including prenatal genetic testing, oncology, infectious diseases, and organ transplantation.
The firm announced its plans to develop a urine-based HPV assay to detect the presence of high-risk HPV subtypes last month. The test preferentially amplifies a specific region of the HPV genome of high-risk HPV types, but not of low-risk types.