MicroGenDX Next-Generation Sequencing Eliminates Post-Surgical Infections for Kidney Stone Removal in Groundbreaking Clinical Trial
Study shows MicroGenDX approach has the potential to revolutionize the prevention of postoperative infections.
LUBBOCK, Texas, October 26, 2023 (Newswire.com) - 27.9 million men and women in the United States will suffer from kidney stones during their lifetime (U.S. Department of Health and Human Services). In 2022, more than 600,000 kidney stone surgeries were performed according to the CDC’s National Center for Health Statistics. Kidney stone removal surgery (ureteroscopy lithotripsy) is among the most common surgeries in urology. An estimated 42,000 people in 2022 suffered from post-surgical infections, plaguing women more often than men despite more men needing kidney stone surgery. One in 40 people who suffer infections end up back in the hospital and such infections can result in sepsis and become deadly.
To prevent post-surgical infections, antibiotics are commonly administered prophylactically prior to surgery. The post-surgical infections that still occur indicate the failure of traditional testing methods (Culture & Sensitivities or “tube and plate”) to provide sufficient guidance as to antibiotic choice. Ideally, a positive urine culture would guide the selection of antibiotics, but pre-op urine tests are often negative and antibiotic prophylaxis selection must instead rely on imprecise empiric guidelines to aid in choosing antibiotics.
In a landmark study, "Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional Model," authored by Michael A. Liss, Kelly R. Reveles, Craig D. Tipton, et. al., MicroGenDX's DNA-based testing completely eliminated post-surgical infections among the testing cohort that adhered to recommendations for the prophylactic administration of antibiotics. Those patients administered prophylactic antibiotics based on empiric recommendations—the present standard of care following a negative urine culture—suffered a post-surgical infection rate of 8.5%.
This head-to-head, outcome-based study brings new hope to hundreds of thousands of patients seeking to avoid a potentially life-threatening infection.
The authors note that the additional cost of MicroGenDX diagnostic testing as opposed to traditional culture is $200. A septic event among such patients increases the cost of surgery by $31,843.
The lead author of the study, Dr. Michael Liss, drew the following conclusions.
"Next-generation sequencing (NGS) methods for microbial profiling represent a groundbreaking advance. Our study aimed to answer a critical question: Can NGS microbial profiling revolutionize antibiotic prophylaxis and effectively reduce infections when compared to conventional standards of care? This could mark a paradigm shift in patient care of antibiotic selection before kidney stone surgery.
"In cases where antibiotics poorly matched the NGS findings, there was a significantly higher risk of infection. This underscores the importance of precise antibiotic selection, both for patient outcomes and genuine antibiotic stewardship."
Dr. Liss found the study particularly revealing as to the difference between men and women in being vulnerable to post-surgical infection.
"It's essential to acknowledge the gender-related disparities in infection risk, indicating that women may be more vulnerable and possess distinct microbial profiles."
Rick Martin, CEO of MicroGenDX, remarked:
"This clinical trial represents a significant milestone in the field of urologic stone interventions. Our collaboration with the University of Texas Health Science Center, San Antonio and the successful application of NGS-guided antibiotic prophylaxis showcase our commitment to advancing patient care and improving healthcare outcomes.
"We are thrilled to see that this innovative approach has the potential to revolutionize the way we prevent postoperative infections, offering a more personalized and effective solution."
For more information about the study, please refer to the full article in European Urology Open Science (Volume 57, 2023, Pages 74-83).
Founded in 2008, MicroGenDX has become the industry leader in the rapid turnaround and affordability of comprehensive Next-Generation Sequencing (NGS) and qPCR testing for clinical diagnostics.
MicroGenDX is a CLIA-licensed and CAP-accredited laboratory and has been the trusted research partner for the CDC, U.S. Army, NASA and the FDA. MicroGenDX has published over 70 clinical studies and is the most experienced molecular diagnostic laboratory, with more than 1.5 million samples processed.
About Michael A. Liss
Dr. Michael Liss is a specialist in the genitourinary microbiome and cancers, with an emphasis on kidney and prostate cancer. He graduated with research honors from the Medical School of Wisconsin and pursued advanced training in laparoscopic and robotic urology at the University of California, Irvine. Following this, he completed a prestigious two-year fellowship in urologic oncology at the University of California, San Diego, approved by the Society of Urologic Oncology, and obtained a Master of Applied Science in Clinical Trials (MAS) during this period.
Dr. Liss currently serves as the site principal investigator for SWOG, one of the world's largest cooperative clinical trial groups, and serves as medical director of clinical research at University Hospital.
Source: MicroGen DX - qPCR + NGS Diagnostics