PHASE Scientific Unveils World-first, Hong Kong-developed, Ground-breaking Urine DNA Concentration Technology for Early HPV Detection to Curb Cervical Cancer

The proprietary technology PHASIFY^TM, developed by Hong Kong scientist and PHASE Scientific Founder Dr Ricky Chiu, has been shown to overcome the limitations of liquid biopsy by effectively concentrating and purifying target analytes in patient specimens, thereby enabling extraction capacity beyond existing gold standards.

Today, PHASE Scientific has launched a world-first urine DNA concentration technology for human papillomavirus (HPV) detection. This innovative technology allows a convenient, non-invasive, and painless testing option for 27 high and low-risk HPV types through self-collected urine samples. This advanced test surpasses the limitations of traditional HPV and pap smear tests, reducing the risk of developing cervical cancer.

PHASE Scientific has launched a world-first urine DNA concentration technology

for human papillomavirus (HPV) detection

With 46 Patents Granted, PHASIFY^TM Enters Urine Testing

Urine is the easiest form of human specimen to obtain – sampling is non-invasive, can be collected at home, and collected frequently. Clinical evidence increasingly shows that meaningful target analytes can be found in urine. However, the presence of these targeted analyte is much lower in urine than in other types of bodily fluid specimens, making them more difficult to detect.

PHASE Scientific has first applied its proprietary PHASIFY^TM technology in urine DNA testing. The technology can process and concentrate large volumes of urine specimen, extracting over 10-times more target analytes compared to the industry gold standard. This significantly improves diagnostic sensitivity for disease detection, and greatly expands clinical applications for urine testing.

According to Dr Chiu, the key to improving diagnostic accuracy lies in the specimen quality. He said that the PHASIFY^TM technology has great potential in improving diagnostic sensitivity, which can be applied in the screening, monitoring, and diagnosis of cancers and other diseases in the future.

The use of PHASIFY^TM for disease screening can improve the detection of genetic mutations or viral infections in urine specimens, particularly for bladder cancer, prostate cancer, cervical cancer, and other urologic cancers. The technology can also facilitate post-treatment surveillance and recurrence monitoring for cancer patients, enabling physicians to provide more timely and personalized treatments. Furthermore, the technology can be applied to non-invasive prenatal testing for identifying down syndrome and other genetic diseases.

The PHASIFY^TM technology can process and concentrate large volumes of urine specimen,

extracting over 10-times more target analytes compared to the industry gold standard

World-first, Proprietary Urine DNA Concentration Technology for Comprehensive Detection of HPV and Early Prevention of Cervical Cancer

PHASE Scientific’s PHASIFY^TM urine DNA technology is now being used for human papillomavirus (HPV) detection. The INDICAID^TM HPV Urine Test, a novel cervical cancer screening test using PHASIFY^TM urine DNA concentration technology, can be utilized for early detection of HPV infection, and is an important tool to help prevent cervical cancer.

Over 95% of cervical cancers are caused by persistent HPV infection. The World Health Organization recommends the use of HPV tests as the preferred method for cervical screening in its new guideline published in 2021, which aims to eliminate cervical cancer by 2030. The Department of Health of the HKSAR Government also advocates for women aged 30 to 64 to use HPV tests to screen for cervical cancer.

In Hong Kong, cervical cancer causes over 500 new cases and is a leading cause of female cancer deaths. According to the Department of Health's Report of Population Health Survey 2020-22, nearly 50% of women in the city have never undergone cervical cancer screening. Typically, cervical cancer screening requires invasive collection of cervical samples, which can cause discomfort and even bleeding.

The INDICAID^TM HPV Urine Test overcomes the above-mentioned limitations by allowing users to self-collect urine samples at home, which can then be sent to the laboratory for testing. This process is painless, convenient, private, and non-invasive, making cervical cancer screening more accessible. An electronic report is available within 5 business days after specimen submission.

Men can contract HPV and transmit cancer-causing strains to their female partners, increasing their risk of developing cervical cancer. Current HPV testing for men involves uncomfortable and embarrassing penile swab samples, similar to pap smears for women. The INDICAID^TM HPV Urine Test is suitable for both men and women, enabling early detection and treatment of HPV-caused diseases, and helping men reduce their partners' risk of developing cervical cancer.

The INDICAID^TM HPV Urine Test delivers a 98.1% accuracy agreement with cervical / penile swab tests, and provides a comprehensive report for 27 types of HPV at once. Of these 27 HPV types, 14 are high-risk HPVs (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), twelve of which has been classified by the International Agency for Research on Cancer (IARC) as Group 1 carcinogens. 13 are low-risk HPVs (6, 11, 26, 30, 34, 53, 67, 69, 70, 73, 82, 85, 97), out of which, two are classified Group 2 carcinogens, and HPV 6 & 11 are known to cause 90% of genital warts.

The INDICAID^TM HPV Urine Test is painless, convenient, private, and non-invasive,

making cervical cancer screening more accessible

Acquisition of ONCO Medical Laboratory to Provide Comprehensive Protection for Women in Hong Kong

Early detection and treatment of cervical cancer are crucial for improving recovery chances, with a 5-year survival rate of up to 95% for early-stage cervical cancer. However, as early-stage cervical cancer may not have noticeable symptoms, regular screening is essential. If high-risk HPV types are detected during a screening, medical professionals will typically recommend a pap smear test to check if any pre-cancerous changes in cervical cells are present. For those with negative HPV test results, the Hong Kong Department of Health recommends women between the age of 30 to 64 to regularly screen for the virus once every 5 years.

To offer comprehensive protection for women in Hong Kong, PHASE Scientific will provide a complimentary pap smear test to women who test positive for any of the 14 high-risk HPV types after using the INDICAID^TM HPV Urine Test. Dr. Chiu stated that the company's objective is to support patients through every step of their healthcare journey, ensuring access to proper support from early screening, diagnosis, treatment, and ongoing monitoring.

PHASE Scientific has also announced the recent acquisition of ONCO Medical Laboratory which adds to the company’s expanding portfolio of providing one-stop cervical screening and follow-up diagnostic support services for women in Hong Kong. ONCO Medical Laboratory is accredited by the Hong Kong Laboratory Accreditation Scheme for its high-quality pap smear testing services, and is one of the four approved local service providers for pap smear testing. Prior to the acquisition, ONCO Medical Laboratory collaborated closely with PHASE Scientific as a Government community testing contractor, conducting over 8 million COVID-19 PCR tests for Hong Kong residents.

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