World’s First Urine-Based HPV Test to Transform Cervical Cancer Screening

Human papillomavirus (HPV) is a very common sexually transmitted infection (STI) that causes more than 95% of cervical cancer cases. Detection of HPV infections that lead to cellular transformation, followed by timely treatment, can lower the risk of developing cervical cancer.HPV testing is the most cost-effective technique for cervical screening. However, traditional cervical cancer screening methods can be invasive, uncomfortable, and require clinical visits, creating barriers to regular testing. Now, the world’s first urine-based HPV test that empowers convenient sample collection could potentially transform cervical cancer screening by making it more accessible and comfortable.

PHASE Scientific (Hong Kong) has developed the world’s first urine-based HPV test—a major breakthrough that has achieved significant clinical validation and global recognition. The company’s INDICAID HPV Urine Test can detect 14 types of high-risk HPV in urine samples, helping users identify cancer risks earlier and seek appropriate treatment options sooner.​ The test is based on the company’s proprietary urine concentration technology designed for molecular diagnostics that is setting a new industry benchmark by capturing approximately 10 times more target analytes from urine specimens compared to the current gold standard. The innovative PHASIFY technology enables the concentration and purification of unlimited volumes of urine, dramatically increasing the sensitivity and accuracy of disease detection.

Image: INDICAID HPV Urine Test can detect 14 types of high-risk HPV using patented urine DNA concentration technology (Photo courtesy of PHASE Scientific)

PHASIFY technology enables at-home sample collection through urine, potentially increasing screening rates and earlier detection of HPV infections that could lead to cervical cancer. In a recent clinical study, the INDICAID HPV Urine Test demonstrated 93.4% sensitivity in detecting CIN2+ lesions (cervical precancer and cancer) and over 97% concordance with the gold-standard physician-collected testing for HPV types 16 and 18. Beyond HPV testing, the company is also developing a comprehensive suite of non-invasive tests for early detection of cancers, women’s health conditions, and infectious diseases based on its urine concentration platform.

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