By Charles Harkness on April 6, 20202020-04-06
Preparing for a clinic visit can often mean preparing for a liquid biopsy – biological fluid samples taken for diagnostic analyses. Most commonly, liquid biopsies are blood samples. Inside blood samples, and other liquid samples, are biomarkers: measurable substances whose presence or lack thereof are indicative of illness. Given the medical relevance of biomarkers, many researchers are in constant search for new and specific markers that can quantify health states.
Blood samples and other invasive biopsies have clinical usefulness, but are not suitable in all situations. For example, access to health care clinics can make it challenging for patients in need of invasive biopsies requiring medical personnel to administer. Researchers at DNA Genotek sister company, Novosanis, have developed a better liquid biopsy solution and have found new clinical relevance using a well-known non-invasive liquid biopsy - urine. Learn more about the biomarker capabilities of urine here.
Assay advances and new collection techniques have uncovered the potential of urine samples. Previously, non-invasive urine sampling, which generally captured midstream urine, missed valuable biomarkers by washing away the buildup of cellular debris, circulating cells, RNA, proteins and other biological components in the first portion of urination. The first 20mL of urine release, termed first-void urine (FVU), contains significant biomarkers and a greater concentration from the debris buildup.1 Cervical cancer, in particular, leaves behind a significant amount of debris from exfoliated superficial cell layers around the cervix carcinoma, which is released in FVU, making it rich in cancer biomarkers. However, cervical cancer, which affects 576,000 women worldwide and makes up 6.8% of female cancers, still relies heavily on invasive sampling methods.2
Invasive sampling methods create greater barriers to healthcare and cancer screening. For women in low and middle-income countries, where access to healthcare may be limited, FVU collection allows a simple, scalable solution to increase participation in screening programs. Screening for Human Papillomavirus (HPV), the primary cause of cervical cancer, has varying recommendations based on age and risk factors, and even country guidelines; the American College of Obstetrics and Gynecologist and National Institute of Health (NIH) outlines HPV testing, in general, for women 30+ years of age once every five years.3 Unfortunately, women in highly rural areas are often unable to access HPV screening through current available tests. For example, in Kenya, HPV screening has an estimated rate for women aged 30-39 of 5.9% every three years.4 Approval of FVU as a viable early cancer detection biopsy could potential lead to self-screening for HPV across many populations in need, ultimately, decreasing indices of cervical cancer.
Collecting urine samples for HPV detection is challenging with non-standardized sampling methods and collected samples can show large variability of biomarkers. HPV DNA is concentrated in FVU and capturing this portion of urine stream is vital to ensure proper analysis. Relying on precision aim is not enough when it comes to effectively collecting FVU; Novosanis has developed Colli-Pee, a CE-marked and FDA listed sampling device to allow efficient and volumetric collection of the first mL of urine flow (up to 20 mL.)5 Designed to be accessible, the Colli-Pee device allows retention of biological information concentrated in the first portion of a urine stream, while eliminating waste.
Benefiting screening methods further, samples collected with Colli-Pee can be stored for a longer duration in collectors tubes prefilled with a unique urine conservation medium, which allows stabilization of DNA. This means samples collected away from a lab or clinic can survive long trips to be assayed without the need for cold chain shipping (ie dry-ice.) Colli-Pee’s non-invasive self-sampling method allows for easy, remote sampling to those in need.