As more tests find their way from the lab to the clinic, regulations and quality control become more stringent. As a result, standardization of collection and stabilization of the biological samples used for diagnostic purposes (e.g. biomarker detection and follow-up; infection screening; ...) are highly relevant.
By 2040, 29.5 million new cancer cases are estimated, compared to 18.1 million cases reported worldwide in 20181. Biopsies are essential for early cancer detection, which increases survival rates and improve overall quality of life. As obtaining tissue can be difficult, urine as a liquid biopsy offers enormous potential for cancer biomarker testing. Urine has proven to be a valuable source of biomarkers and can provide complementary information to plasma or tissue tests for different types of cancers (e.g. breast, lung and prostate cancer) 2-4.
Human Papilloma Virus (HPV)
In many populations, up to 80% of sexually active women are infected with the human papilloma virus (HPV), at some point in their lives 5,6. HPV is the principal cause of cervical cancer (CC) which is the fourth most common type of cancer in women, and responsible for over 300.000 deaths worldwide. The gold standard to screen for CC is based on cytologic evaluations of physician-taken smear (PTS). This is challenged by high non-attendance rates. HPV-based testing offers the potential to use non invasive and easy self-collection of urine, which provides a more accessible and acceptable method for CC screening 5,6.
Sexually Transmittable Infections (STI's)
Yearly, 376 million new cases of curable sexually transmitted infections (STIs) occur 7. Around 70% of countries have STI surveillance systems, but many populations face barriers to screening: stigma, confidentiality concerns, cost, lack of services, transport, knowledge and awareness about STI's 8. Home-based self-collected samples, like urine sampling has the potential to improve screening rates 9.
Urine is a non-invasive sample with a growing number of clinical applications. The Colli-Pee® platform offers improved diagnostic accuracy and patient comfort compared to a regular urine cup. The platform consists of variants capturing different volumes for different application purposes. Collector tubes can be prefilled with a preservative, allowing longer storage and shipment at room temperature. The device is easy-to-use, and suited for home-collection, hereby reaching more individuals.