Rapid UTI Assay for
Guided Therapy

Using Quantitative Microbiology

Our mission

Renascent Diagnostics

Speed. Accuracy. Efficiency.

Renascent Dx is bringing the first automated digital microbiology platform to market to provide test results faster for patients and ultimately address the worldwide issue of antibiotic resistance that is affecting every area of clinical medical practice. At Renascent Dx we believe accurate results delivered faster improves both patient care and our general health community.

Our Applications

empiriSTAT- UTI

Renascent’s comprehensive assay for assessing urine specimens for suspicion of urinary tract infection aims to transform UTI testing. Providing enumerative values for WBCs, viable bacteria, and standardized antibiotic profiling in under 3 hours directly out of the specimen, Renascent’s empiriSTAT-UTI test is fast enough to ensure appropriate therapy early in the disease course.

Our Science

Utilizing an ultra-sensitive, automated flow cytometric platform coupled to proprietary chemistry Renascent is able to assess a multitude of parameters at an incredibly high rate to identify not just bacteria present in a sample but viable bacteria directly out of a specimen without the need for lengthy cultures. With the addition of a short incubation Renascent’s technology is able to determine the effect of a panel of antibiotics with high accuracy compared to broth microdilution and Kirby-Bauer methodologies.

Our Science Applied

Renascent Diagnostics is utilizing what we believe is the world’s most advanced cytometer platform to execute our empiriSTAT assays. With unmatched pre-analytical processing the system allows for “load-n-go” functionality, ensuring automated, standardized, and accurate assay execution.

Renascent Diagnostics has developed proprietary chemistry for its empiriSTAT UTI assay that optimizes the identification of viable bacterial cells in urine specimens within minutes. This optimization has shown very high correlation to CFU enumeration after overnight culture. This differentiation between viable and non-viable bacterial cells is the key to accurate clinical diagnosis of UTI using empiriSTAT-UTI. Viable bacteria and WBC enumeration are only minutes away with Renascent Diagnostic’s empiriSTAT-UTI.

Renascent Diagnostics has spent over 7 years optimizing both bacterial gating strategies for direct assessment of UTI out of urine specimens as well as internal QC algorithms that ensure assay integrity for each sample. Additionally, the empiriSTAT-UTI algorithms allow for rapid profiling of antibiotic effects on the bacterial population allowing for patients to initiate appropriate therapy from the start.

Robust, validated science is at the core of Renascent Diagnostics technology. With the new demands of 21st century pathology labs in mind, the Renascent empiriSTAT- UTI assay aims to redefine UTI diagnostics.

Renascent diagnostics

Our Team

Renascent Diagnostics is building out its world-class team focused on commercializing its diagnostic platform with members embodying expertise in Quality Management, IVD Manufacturing, Clinical Development, and Regulatory submissions. Additionally, RDI is establishing a team of established experts in clinical microbiology, infectious disease, and clinical care to represent its Medical Advisory Board.

Matthew Gombrich,
M.D., M.S.

CEO & Founder

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Antibiotic Resistance Resources and References

An Introduciton to the Epidemiology and Burden of UTIs

“Urinary tract infections (UTIs) are the most common outpatient infections, with a lifetime incidence of 50−60% in adult women. This is a narrative review aimed at acting as an introduction to the epidemiology and burden of UTIs.”

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National Action Plan for Combating Antibiotic-resistant Bacteria

“The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), 2020-2025, presents coordinated, strategic actions that the United States Government will take in the next five years to improve the health and wellbeing of all Americans by changing the course of antibiotic resistance.”

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Urinary Tract Infection Antibiotic Resistance in the United States

“Urinary tract infection (UTI) is one of the most common entities in medicine and affected patients present daily in a typical family medicine practice. In most cases, an antibiotic is prescribed, and this practice is likely contributing to increasing worldwide antibiotic resistance.”

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Urinary Tract Infections Affect Millions

“As the infections become increasingly resistant to antibiotics, some standard treatments no longer work for an ailment that was once easily cured.”

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Why We Need to Act

Get in Touch

Renascent Diagnostics

If you’d like to learn more about our science, the clinical benefits of rapid detection of UTI, or our business plans please feel free to fill out the information form and we will be in touch.

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