Simple Urine Test Could Help Diagnose, Track ALS Progression

Researchers at Australia’s Flinders University have identified a new potential biomarker in the urine of patients with amyotrophic lateral sclerosis (ALS).

Biomarkers are biological molecules found in body fluids, such as urine or blood, which can be a sign of disease or disease progression. These molecules not only help doctors diagnose a condition, but also help them understand how well the body responds to a particular treatment.

ALS currently has no validated biomarkers, and the newly identified molecule is the only biological fluid-based biomarker of disease progression. The newly identified biomarker is a protein called p75ECD. Previous work has shown that p75ECD levels are found in higher than normal levels in the urine of ALS patients.

The report, “Urinary p75ECD, A prognostic, disease progression, and pharmacodynamic biomarker in ALS,” appeared in the scientific journal Neurology.

“A standardized, easy-to-collect urine test could be used as a more accurate progression and prognostic biomarker in clinical trials,” said the study’s senior author, Dr. Mary-Louise Rogers, in a press release. “This will accelerate progress towards more rapid identification of improved treatments for [motor neurons disease] and save time and money by faster exclusion of less effective or ineffective drugs.

In order to evaluate whether p75ECD can be used as a reliable marker to diagnose and follow the progression of ALS, Rogers and her team measured the level of p75ECD in the urine of 54 ALS patients and 45 healthy volunteers.

They found, as in previous studies, that levels of this protein were higher in the urine of people with ALS compared to healthy individuals. The results did not change at different temperatures, or after the urine samples were frozen and thawed repeatedly or kept in the fridge for two days. It also didn’t matter what time of day or night the urine samples were collected.

Importantly, levels of p75ECD in the urine correlated with how advanced the ALS was, and rose as the disease progressed.

The authors concluded that in the future, p75ECD “could potentially be used to test people for early signs of pre-familial [ALS] progression and used instead of patient questionnaires for regular testing of disease progress or drug suitability in existing [ALS] cases.”

 

[https://alsnewstoday.com/2017/02/24/urine-test-als/]

 

Urine Test for HPV Works Well, Analysis Finds

By Kathleen Doheny

HealthDay Reporter

TUESDAY, Sept. 16, 2014 (HealthDay News) — A simple urine test can routinely spot human papillomavirus (HPV), which is linked to the risk of cervical cancer, a new analysis found.

“Our study shows that testing urine for HPV has good accuracy when compared to testing samples taken from the cervix for HPV,” said lead researcher Dr. Neha Pathak. She is a resident in obstetrics and gynecology and research fellow at Queen Mary University of London, England.

The test could be done at home, and then interpreted by medical professionals, Pathak added.

With her colleagues, Pathak reviewed 16 published articles reporting on 14 studies that looked at the HPV urine test.

While the test is not yet widely available or included in any screening guidelines, Pathak said it has potential, but more research is needed. Right now, women only receive this test in the context of research, she explained.

HPV is one of the most common sexually transmitted infections. Up to 80 percent of sexually active women are infected at some point in their lives, according to background information in the study.

Often, the infection will clear up on its own, but up to 20 percent of women have persistent infections. Specific strains of HPV have been linked with the development of cervical cancer.

About 12,300 new cases of cervical cancer will be diagnosed this year, according to American Cancer Society estimates, and about 4,000 women will die of the disease in 2014.

For early detection of cervical cancer, women can undergo a Pap test. At the same time, a cervical HPV test can be done to check for the presence of the virus.

However, the study authors noted, there has been a decline in screening, so they wanted to see if a more convenient test would be as accurate.

Compared with cervical samples, the HPV urine test correctly identified positive results 87 percent of the time. The urine tests correctly identified negative results 94 percent of the time. When it came to the high-risk strains of the virus — HPV 16 and 18 — the urine test correctly identified positive results 73 percent of the time and negative results 98 percent of the time.

Although more research on the test is needed, the concept has potential, said Fred Wyand, a spokesman for the American Sexual Health Association and the National Cervical Cancer Coalition.

“Were such a test ever approved for clinical use, it would be a unique addition to the options health care providers currently have to screen women for cervical cancer,” Wyand said. “The uniqueness of the urine specimen would be in comparison to current offerings of screening tests that involve taking a physical sample of cells from the cervix.

“A urine assay for the virus might be helpful in large research studies, for example,” he added. “It could also be a boon in settings where more traditional means of screening for cervical cancer are difficult due to cultural resistance to gynecologic exams.”

The new study findings appear in the Sept. 16 online issue of thebmj.com.

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Urine Test for Kidney Cancer Shows Promise

Simple screen used levels of two proteins to spot the disease with 95 percent accuracy, study found

 

FRIDAY, March 20, 2015 (HealthDay News) — A urine test might someday become a much-needed early detection test for kidney cancer, a new study suggests.

“This research is very important and a significant finding, because we do not have a good screening mechanism for kidney cancer,” said one expert, Dr. Ketan Badani, professor of urology at the Icahn School of Medicine in New York City.

The study was led by Dr. Evan Kharasch, professor of anesthesiology at Washington University School of Medicine. His team said that kidney cancer patients whose disease is diagnosed before the tumor spreads have an 80 percent survival rate.

However, if the cancer is not spotted until after it has spread, 80 percent of patients die within five years. According to the researchers, finding the disease early — before it has spread — has remained a major challenge.

“The most common way that we find kidney cancer is as an incidental, fortuitous finding when someone has a CT or MRI scan,” Kharasch explained in a university news release. “It’s not affordable to use such scans as a screening method, so our goal has been to develop a urine test to identify kidney cancer early.”

In the new study, his team found that measuring levels of two proteins in urine was more than 95 percent accurate in identifying early stage kidney cancer, with no false-positive results triggered by the presence of non-cancerous kidney disease.

The investigators analyzed urine samples from 720 patients scheduled to undergo abdominal CT scans unrelated to a suspicion of kidney cancer, along with samples from 80 healthy people and 19 people previously diagnosed with kidney cancer.

The urine samples were checked for levels of the proteins aquaporin-1 (AQP1) and perlipin-2 (PLIN2). None of the healthy people had elevated levels of either protein, but kidney cancer patients had elevated levels of both proteins.

Three of the 720 people who had abdominal CT scans also showed elevated levels of both proteins. Two of those people were later diagnosed with kidney cancer, and the third died of other causes before a diagnosis was made, according to the findings published March 19 in the journal JAMA Oncology.

“These biomarkers [chemical signals] are very sensitive and specific to kidney cancer,” Kharasch said in the news release.

Badani applauded the research, but cautioned that more study is needed.

“A urine-based screening test would be a very easy and convenient way to screen for kidney cancer and fill a void that currently exists today,” said Badani, who also directs the Comprehensive Kidney Cancer Center at Mount Sinai Health System in New York City.

However, he stressed that “larger studies with more patients from different populations, both geographically and racially, will need to be conducted to confirm these findings.”

Dr. Maria DeVita is associate director of nephrology at Lenox Hill Hospital in New York City. She called the study results “great news.”

If confirmed in larger trials, “this advancement will enhance the diagnosis of this cancer by means of an easily obtained, readily available urine sample,” DeVita said. “We look forward to the day when the use of these biomarkers is part of everyday medical practice.”

According to the American Cancer Society, kidney cancer is diagnosed in about 62,000 people a year in the United States, and about 14,000 die of the disease each year.

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[http://www.webmd.com/cancer/news/20150320/urine-test-shows-promise-for-early-diagnosis-of-kidney-cancer#1]

Urine Test For H.I.V. Is Approved

Federal health officials yesterday approved the first urine test to detect H.I.V., the virus that causes AIDS, but said it was not as accurate as the standard blood test.

The urine test was approved as a supplemental diagnostic test, but is not meant to substitute for the standard blood test to screen donors at blood banks, officials of the Food and Drug Administration said.

The reason is that studies showed that the number of times the urine test failed to detect evidence of H.I.V. in an individual known to be infected was higher than for the standard blood test. Also, the urine test indicated that some people were H.I.V.-infected when it was known that they were not.

Those who test positive for H.I.V. with the urine test are advised to get a second urine test, and if that is also positive, they then need a blood test for confirmation. The F.D.A. has advised doctors who use the test to counsel those who use the urine test and explain that a negative test is not a guarantee of being free of infection.

Dr. Curtis Scribner, an official of the Federal Food and Drug Administration, said that with further improvement the urine test ”could develop into” a first-line test for H.I.V.

A urine test ”could become a significant weapon in the battle to slow the AIDS epidemic because it makes testing safer, easier and more accessible” compared with the standard blood test, Darrel Cummings, deputy executive director of the Los Angeles Gay and Lesbian Community Services Center, said in a statement released by Calypte Biomedical Corp. of Berkeley, Calif.

Calypte developed the test, which detects antibodies to H.I.V. present in simple plastic-cup specimens of urine. Calypte has licensed Seradun Inc. of Indianapolis to market the test under the name Sentinel.

The urine test does not require specially trained health-care workers to administer it or needles that could pose hazards to those who withdraw blood from an individual’s vein.

The F.D.A. limited its approval for the urine test to health professionals so that individuals would have to give urine samples to doctors in hospitals, offices and clinics. The test may also be used in examinations to obtain insurance.

Dr. Luc Montagnier, a co-discoverer of the AIDS virus and a scientific adviser to Calypte, said the relative simplicity of the urine test ”holds particular important promise for developing countries” where trained health professionals are in short supply.

Calypte’s stock rose $2 yesterday to close at $9.625 on the Nasdaq. The company went public in late July,

Approval of the urine test was based on comparing it with the blood test in several studies involving more than 800 individuals known to have AIDS, to be H.I.V.-infected, or to be at high risk for the disease.

In one study, 298 individuals diagnosed with AIDS gave urine and blood samples. The urine test was positive in 99.3 percent of the cases, the F.D.A. said.

In other studies involving individuals known to be H.I.V.-infected, some of whom had developed symptoms from damaged immune systems, the urine test missed about 1 to 2 infections in every 100 tested.

Still other studies showed that the urine test would falsely indicate H.I.V. infection when none was present in 1 to 2 people in 100 tested, compared to 1 in 1,000 with a blood test.

Additional studies included gay men, drug users who were injecting drugs, and other individuals in groups considered at high risk for AIDS. While the urine test falsely indicated infection in from 1 to 3 out of 100 such individuals, it was as high as 18 percent in some groups, Dr. Scribner said.

Correction: August 9, 1996, Friday An article on Wednesday about the Government’s approval of the first urine test to detect H.I.V., the AIDS virus, misspelled the name of the company that will market the test. It is Seradyn (not Seradun) Inc.

[http://www.nytimes.com/1996/08/07/us/urine-test-for-hiv-is-approved.html]