ORLANDO, Fla.--(BUSINESS WIRE)--A first-of-its-kind study to help treat Urinary Tract Infections (UTIs) is underway through a research partnership with one of the world’s leading medical experts in treating UTIs and a company that uses advanced DNA technology to identify microbes that cause infection so that doctors can target precise medical treatment.
Dr. J. Curtis Nickel, Research Chair in Urologic Pain and Inflammation at Kingston General Hospital Kingston, Ontario, Canada, is working with MicroGenDX, an Orlando, Fla.-based company that operates a high complexity diagnostic laboratory, to establish a baseline for what microbes are present on “normal” urine – that is – urine from those not currently experiencing any type of infection.
"The future of managing infectious disease in Urology will involve determining the pathogenic ecology of the lower urinary tract obtained with non-culture molecular diagnostic technology, such as Next Generation Sequencing (NGS),” said Dr. Nickel. “Until we know what the normal microbiome looks like in healthy individuals, it will remain difficult to interpret NGS microbiome results from urine specimens submitted by symptomatic patients.”
Other medical experts are also excited about this groundbreaking research. "Our microbiome plays a pivotal role in our health and survival, yet we really don’t know what ‘normal’ is for the urinary tract of men and women,” said Dr. E. David Crawford, Professor of Urology at University of California San Diego. “This is one of the most important clinical studies to date in this area. I encourage healthy individuals to be a contributor to this study.”
UTIs are the most common outpatient infections in women today, according to a recent peer-reviewed article in Therapeutic Advances in Urology. UTIs will affect 50−60% of adult women, with women over 65 experiencing almost double the rate as the female population overall. As many as one-in-five women suffer from recurrent UTIs, those that occur at least twice in six months or three times per year. While UTIs are more common among women, men can also fall victim to these stubborn infections. According to the National Kidney Foundation, UTIs account for some 10 million healthcare visits per year.
The driving force behind the study is MicroGenDX, which identified the need for this research, collaborated with Dr. Nickel in its design and managed the FDA-required Institutional Review Board process required for this type of medical research. Additionally, MicroGenDX is donating approximately $120,000 in lab services for collection, shipment and analysis of samples.
“Our support of this research is a part of our ongoing effort to advance the science of detecting, identifying and treating viral, bacterial and fungal infections,” said MicroGenDX CEO Rick Martin. “We are honored to be working with the world’s leading experts and look forward to the findings of this study, which will help improve the lives of those suffering with recurrent UTIs.”
In order to participate in the study, a person should be in good urological health and cannot have taken any antibiotic or antifungal medication for the past three months. Those wishing to participate in the study just need to complete an online questionnaire. Those selected for the study will be sent a urine collection kit, which can be used at home and returned in a prepaid package to MicroGenDX. There is no cost to participate, and each participant will receive his or her results. Those wanting to participate or learn more about the study can go to https://microgendx.com/healthymicrobiomestudy/. Researchers hope to conclude the study later this year.
About Dr. J. Curtis Nickel
J. Curtis Nickel, MD, FRCSC, is Professor of Urology and Research Chair in Urologic Pain and Inflammation at Kingston General Hospital Kingston, Ontario, Canada. He has over 550 publications, is on the editorial board of eight Urology journals, editor of the AUA Update Series, presented in 45 countries, funded by US NIH and Canadian CIHR and was awarded a CIHR Tier I Canada Research Chair (until 2021), AUA Distinguished Contribution Award and SIU Academy Award. He is currently Immediate Past-President of the Canadian Urological Association.
MicroGenDX is a College of American Pathologists (CAP) accredited and Clinical Laboratory Improvements Amendments (CLIA) licensed clinical laboratory with more than 12 years of experience in diagnosing molecular-based, laboratory-developed tests. MicroGenDX operates a high-complexity diagnostic laboratory that uses Next Generation DNA Sequencing Technology (“NGS Technology”) – rather than the traditional approach of growing cultures – to determine the presence of and identify by their genetic markers specific micro-organisms that are the cause of infections.
MicroGenDX’s technology and mission are improving and saving the lives of patients with serious and often chronic infections and diseases by using the latest science and the most precise diagnostic tool available to identify the cause of infection so that the most effective medicine can be prescribed to treat that infection. Thousands of patients with chronic and often life-threatening infections have benefited from MicroGenDX’s work.