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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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University of East Anglia Researchers Develop Non-Invasive Prostate Cancer Urine Test

The researchers believe their test ‘could reduce the number of unnecessary prostate cancer biopsies by 32%,’ UEA reported

New diagnostic technologies may make it possible for men to provide a urine sample that can allow a clinical laboratory to not only accurately diagnose prostate cancer but also help determine whether it is an aggressive form of prostate cancer. Researchers in the United Kingdom (UK) recently described just such a test in an online, peer-reviewed journal.

Development of a non-invasive method of diagnosing prostate cancer would be significant for anatomic pathologists in the United States. In the US alone, approximately 248,000 men will be diagnosed with this type of cancer in 2021. Prostate biopsies represent a major proportion of case referrals to community pathology groups.

Moreover, were such a non-invasive test for prostate cancer also able to identify those individuals with fast-growing prostate cancers, that would help urologists make more informed treatment decisions.

A Disease Men More Commonly Die ‘With’ Rather than ‘From’

According to CDC statistics, most men over the age of 80 will have some form of slow-growing prostate cancer when they die. However, a percentage of men each year contract a rapidly growing aggressive form of the cancer, and until recently, diagnosing which cancer a patient was fighting often required multiple invasive prostate needle biopsies. But that may soon change.

Researchers at the University of East Anglia (UEA) Norwich Medical School in the United Kingdom (UK) have developed a non-invasive urine test for prostate cancer that they say also can determine the aggressiveness of the disease. Knowing this may help physicians better assess a patient’s risk prior to ordering invasive needle biopsies, a UEA article notes.

The UEA test may also allow for self-collection of the biological sample, and if it proves accurate, the test could bring additional revenue to clinical laboratories that would perform the urine testing.

The UEA researchers published their study in the peer-reviewed open-access journal Cancers, titled, “Integration of Urinary EN2 Protein and Cell-Free RNA Data in the Development of a Multivariable Risk Model for the Detection of Prostate Cancer Prior to Biopsy.”

“In this work we develop a test that predicts whether a patient has prostate cancer and how aggressive the disease is from a urine sample. This model combines the measurement of a protein-marker called EN2 and the levels of 10 genes measured in urine and proves that integration of information from multiple, non-invasive biomarker sources has the potential to greatly improve how patients with a clinical suspicion of prostate cancer are risk-assessed prior to an invasive biopsy,” they wrote.

“While prostate cancer is responsible for a large proportion of all male cancer deaths, it is more commonly a disease men die with rather than from,” said Daniel Brewer, PhD, one of the lead researchers on this study. “Therefore, there is a desperate need for improvements in diagnosing and predicting outcomes for prostate cancer patients to minimize over-diagnosis and overtreatment whilst appropriately treating men with aggressive disease, especially if this can be done without taking an invasive biopsy.

“Invasive biopsies come at considerable economic, psychological, and societal cost to patients and healthcare systems alike,” he added. Brewer is Senior Lecturer in Cancer Bioinformatics and a group leader within the Cancer Genetics Team at UEA’s Norwich Medical School.


“Our new urine test not only shows whether a patient has prostate cancer, but it importantly shows how aggressive the disease is. This allows patients and doctors to select the correct treatment,” said Daniel Brewer, PhD (above), Senior Lecturer and Lead Researcher, UEA Norwich Medical School, in the news release. (Photo copyright: Eastern Daily Press.)

Possibility of Reducing Needle Biopsies by 32%

Called “ExoGrail,” the UEA’s new test builds on their earlier development of the Prostate Urine Risk (PUR) and ExoMeth tests. The test works by integrating two biomarkers.

  • Measurements of EN2, a protein-marker, and
  • Levels of gene expression of 10 genes related to prostate cancer.

The researchers tested ExoGrail on urine samples from 207 patients at Norfolk and Norwich University Hospital (NNUH) who also had needle biopsy samples available.

According to the published study, the UEA ExoGrail urine test enabled:

  • Results comparable to the biopsy findings.
  • Identification of people with prostate cancer and people without it.
  • Risk scoring that noted aggressive prostate cancer and need for biopsy.
  • Potential to reduce unnecessary biopsies by 32%.

“ExoGrail resulted in accurate predictions even when serum PSA [protein-specific antigen] levels alone proved inaccurate; patients with a raised PSA but negative biopsy result possessed ExoGrail scores significantly different from both clinically benign patients and those with low-grade Gleason 6 disease, whilst still able to discriminate between more clinically significant Gleason ≥ 7 cancers,” the researchers stated in their published study.

“The adoption of ExoGrail into current clinical pathways for reducing unnecessary biopsies was considered, showing the potential for up to 32% of patients to safely forgo an invasive biopsy without incurring excessive risk,” they noted.

Prostate Cancer Patients May Soon Have Options

While more research is needed, the new UEA Norwich Medical School ExoGrail test introduces compelling non-invasive methods for diagnosing prostate cancer. Patients with findings of aggressive cancer can proceed to biopsies, while others determined to have non-aggressive forms of prostate cancer may be able to avoid more invasive tests and the associated costs and stress.

Additionally, men may soon be able to collect their own specimens without the need to visit the primary care doctor or a patient service center.

A follow-up study underway at the University of East Anglia and the NNUH involves sending 2,000 men in the UK, Europe, and Canada home testing “prostate screening boxes” to “to collect men’s urine samples at-home,” according to a UEA new release, which noted that “the Prostate Screening Box has been developed in collaboration with REAL Digital International Limited to create a kit that fits through a standard letterbox.”

“We have developed the PUR (Prostate Urine Risk) test, which looks at gene expression in urine samples and provides vital information about whether a cancer is aggressive or ‘low risk,’” said Jeremy Clark, PhD, Senior Research Associate at UEA’s Norwich Medical School.

“The Prostate Screening Box part sounds like quite a small innovation, but it means that in future the monitoring of cancer in men could be so much less stressful for them and reduce the number of expensive trips to the hospital,” he added.

Anatomic pathologists and clinical laboratory managers will want to follow the progress of these clinical studies. A non-invasive, urine-based test for prostate cancer could be a game-changer if it can detect prostate cancer with comparable accuracy to the tissue-based diagnostics that are the current standard of care in the diagnosis of prostate cancer.

—Donna Marie Pocius

Related Information:

Integration of Urinary EN2 Protein and Cell-Free RNA Data in the Development of a Multivariable Risk Model for the Detection of Prostate Cancer Prior to Biopsy

New Prostate Cancer Urine Test Shows How Aggressive Disease Is and Could Reduce Invasive Biopsies

Tests to Diagnose and Stage Prostate Cancer

Prostate Cancer Key Statistics

UEA Researchers Develop Prostate Cancer Test That Could Reduce Biopsies

Thousands of Men to Trial Prostate Cancer Home Testing Kit

Point-of Care Urine Drug Test Kits Used by Rehabilitation Programs in Canada and US to Help Drug Users Detect the Presence of Fentanyl in Their Heroin and Opiate Drugs

A legal, supervised injection site (SIS) affiliated with Vancouver Coastal Health found 86% of drugs tested with strips contained fentanyl when tested with these medical lab test kits

Here’s an unexpected application of point-of-care testing (POCT) that may surprise pathologists and medical laboratory leaders. In a sort of “guerilla-warfare” street experiment that applies diagnostic technologies to a problem, the manager of a needle-exchange program in the Bronx has been helping heroin and other opioid users discover if a product they are about to ingest is contaminated by handing out test strips designed for testing urine.

The addicts participating in these special programs use the POCT urine test strips to test their drugs for the presence of fentanyl, a powerful synthetic opioid analgesic similar to morphine that can increase the potency of opioids to lethal levels. Rehab program directors adopted this approach to help prevent overdoses and deaths among drug users.

Reducing Overdoses with Test Strip Handouts

Opioids such as morphine are often prescribed to cancer or surgery patients to treat severe pain. However, according to a National Institute on Drug Abuse (NIDA) fact sheet, fentanyl is “50 to 100 times more potent than morphine.” When fentanyl is mixed with heroin or cocaine and sold on the streets, the potent mix can be deadly, NIDA explained.

Test strips ordered from Canada designed to check patients’ urine for fentanyl are being used by St. Ann’s Corner of Harm Reduction (St. Ann’s) in the Bronx, New York. The strips are being used to check drug users’ syringes for fentanyl, according to a National Public Radio Shots article. The idea is to inform drug users of what they have in hand and possibly encourage them to choose not to take the drug, use less, or slow things down, Shots reported.

“If you’re doing dope, we’ll give you a test strip so you can test and see if there’s fentanyl,” stated Van Asher, Data Manager at St. Ann’s, in the Shots article.

Whether an unlicensed individual distributing test strips to drug users violates state or federal regulations was not broached in the Shots article.

St. Ann’s gives out about 15 strips a day each costing $1, Shots noted. St. Ann’s staff is sharing data collected on the encounters with the Centers for Disease Control and Prevention (CDC) and with New York health departments.

Finding Fentanyl with Test Strips in Canada

St. Ann’s isn’t the first to use urine test strips for drug checking. Vancouver Coastal Health (VCH) in British Columbia, Canada, launched a pilot program for drug-checking in 2016 at its Insite facility.

Insite is a supervised injection site (SIS). It opened its doors in 2003 and operates under a constitutional exemption to Canada’s Controlled Drugs and Substances Act.

At Insite’s “supervised injection site” facility (above) in Vancouver, British Columbia, drug users can “legally” inject illegal drugs. Directors of this program have adapted point-of-care urine test kits typically used in medical laboratory testing to allow drug users to test their heroin and opiate drugs for the presence of fentanyl. The goal is to reduce overdoses and deaths from users unknowingly ingesting fentanyl. (Photo copyright: CBCNews.)


Insite began to test drugs for the presence of fentanyl in the fall of 2016. Data from 173 tests performed in July and August found that 86% of drugs tested contained fentanyl, noted a VCH news release.

“These initial results confirm our suspicion that the local drug supply is overwhelmingly contaminated with fentanyl. We’re hoping this information can help people who use drugs,” stated Mark Lysyshyn, MD, MPH, VCH Medical Health Officer and Professor of Medicine at University of British Columbia.

The test works when the client dilutes the substance with a few drops of water. A positive or negative result for fentanyl is revealed within seconds.

The test strip used by Insite was designed to check for fentanyl in urine, not for checking drugs, noted the VCH statement. Insite intends to review the pilot program test data and decide whether to continue testing services after the pilot program concludes.

Alexander Walley, MD, Director of the Addiction Medicine Fellowship Program and Assistant Professor of Medicine at Boston Medical Center, stated the test may aid users’ decision-making.

“Even when they know they’re going to be positive for fentanyl, the experience of somebody testing their drugs and seeing that it’s fentanyl has an impact. It really encourages them to use more safely,” he stated in the Shots article.

Overdose Deaths Due to Fentanyl in America

A CBC News, Manitoba, article called the death rate due to fentanyl ingestion a “Canada-wide disaster.” However, the problem is significant in the US as well.

Death rates from synthetic opioids, including fentanyl, rose more than 72% from 2014 to 2015 in the US, according to the CDC.

In New York City, fentanyl is increasingly being linked to overdoses. In 2016, nearly half (44%) of drug deaths involved drugs mixed with fentanyl. That’s a 16% increase over 2015, according to a NYC Health press release.

A report from the Tennessee Department of Health noted that 1,451 people died from drug overdose in 2015. That’s a state record. Deaths associated with fentanyl rose significantly from 69 in 2014 to 174 in 2015, the report noted.

How Fentanyl Works and Why It Is Dangerous

Here are some fentanyl facts from the NIDA:

  • Fentanyl works by binding to opioid receptors located in areas of the brain that control pain and emotions;
  • People may experience side effects such as euphoria, drowsiness, nausea, confusion, addiction, respiratory arrest, unconsciousness, coma, and death;
  • Increased risk of overdose exists when drug users are unaware a drug they are ingesting contains fentanyl.

Clinical laboratory directors and pathology groups nationwide might want to follow the progress of test strip services at St. Ann’s Corner and Insite’s SIS. This twist on traditional POCT—using urine test strips to look for the presence of fentanyl in substances—could aid their own communities achieve public awareness, change behaviors, and save lives.

—Donna Marie Pocius

Related Information:

An Experiment Helps Heroin Users Test Their Street Drugs for Fentanyl

86% of Drugs Checked at Insite Contain Fentanyl

Fentanyl Deaths Are a Canada-wide Disaster

5 New Supervised Injections Sites Coming to Fight Vancouver’s Fentanyl Overdose Crisis

1,451 Tennesseans Die from Drug Overdoses in 2015

State Data Confirms Overdose Deaths Primarily White Opioid Users