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Aperture Bio Ready to Introduce its Diagnostic Platform to Combat Antibiotic Resistance Through Rapid Detection of Bacterial Infections & Antibiotic Profiling within Hours

05-07-2019 06:23 PM CET | Health & Medicine

Press release from: Aperture Bio

Aperture Bio Ready to Introduce its Diagnostic Platform

(Dallas, TX - 4/1/19) - After more than two-years of clinical evaluations conducted at Northwestern, Washington University and University of Vermont Medical Center, Aperture Bio has announced it is ready to introduce its proprietary testing platform, the RAPID-BTM, and the empiriSTAT-UTI, for the rapid detection of uncomplicated urinary tract infections (UTIs) and antibiotic profiling performed within hours.

Utilizing highly customized and fully robotic next-gen flow cytometric technology (nFC), coupled with proprietary chemistry and customized platting, the RAPID-BTM platform can discriminate live uropathogen bacteria from those that are dead/damaged, as well as, normal urogenital contaminants, which could result in false positives and lead to unnecessary treatment.

Centered around a sensitive array of lasers, the system enumerates only viable bacteria and white blood cells within minutes and provides Antibiotic Predictive Profiling (APP) within hours. Specifically knowing which patients to treat and providing a rapid, categorical assessment of treatment options could both greatly reduce the risks for millions of patients being unnecessarily overexposed to antibiotics and save millions in healthcare costs.

Achieving 98% sensitivity and 88% specificity, the empiriSTAT-UTI is the first in a series of in vitro tests developed to increase the speed and accuracy of identifying bacterial infections from both urine and blood. The speed and accuracy of the test will reduce turn-around-times with actionable results from days to hours when compared to current screen, culture and reflexed Antibiotic Susceptibility Testing (AST.) By rapidly isolating those patients that are negative vs. positive aids healthcare professionals to quickly and accurately identify not only those patients that may require further treatment, but equally as important, those that do not require antibiotic treatments.

The urgent need to reduce the overuse and misuse of antibiotics through empirical prescribing is at the forefront of the world's public health agencies;

The United Nations (U.N.'s) Interagency Coordination Group on Antimicrobial Resistance released a report in 2019 stating that "drug-resistant infections will kill 10 million people annually by 2050? and specifically calls for "more initiatives aimed at limiting unnecessary antibiotic use."

The World Health Organization (WHO) states, "Antibiotic resistance is rising to dangerously high levels in all parts of the world. New resistance mechanisms are emerging and spreading globally. Without urgent action, we are heading for a post- antibiotic era in which common infections and minor injuries can once again kill."

The Commissioner of the Food & Drug Administration (FDA) stated that "Antimicrobial resistance is a global public health challenge. Combating antimicrobial resistance continues to be a top priority. Our aim is to reduce overuse of antimicrobial drugs and combat the rising threat of resistance."

The Infectious Disease Society of American (IDSA) stated "Because treatment of acute uncomplicated cystitis is usually empirical, it is likely that some women will be treated with a drug that does not have in vitro activity against the uropathogen. As the population resistance prevalence of a specific agent increases, the likelihood of failure outweighs the benefits of using the drug empirically."

The unintentional overuse and misuse of antibiotics is, in great part, due to the empirical over-prescribing in a partially 'blind,? defensive response by caregivers as they await lab results. With reports suggesting that +/-90% of blood and +/-60% of urine cultures come back negative, the ability to accurately and rapid discriminate positive vs. negative patients within minutes for urine, and a few hours in blood, could significantly reduce this overuse and misuse, which is at the foundation of the antibiotic resistance pandemic.

The speed and accuracy of the empiriSTAT test has demonstrated to out-perform other screening methods including chemical strips, microscopy and PCR. Even standard urinalysis screening, which is semiquantitative and lacks precision and standardization, results in a high rate of misinterpretation, which can lead to under-treatment, or more often, over-treatment with empirical antibiotics. When compared to current screening and culture methodology accompanied with follow through AST testing, which all can take days, the RAPID-BTM could change how bacterial infections are detected and treated, disrupting the multi-billion-dollar laboratory testing industry.

In a statement from Matthew Gombrich, MD, M.S, Chief Medical Officer at Aperture Bio, 'in an era of alarming rates of antibiotic resistance, the negative predictive value of what we have achieved cannot be overstated. Reducing the overuse and misuse of antibiotics through new technology like the RAPID-B could help save millions of lives and billions of dollars ...and should be in the hands of healthcare providers today."

Aperture Bio is a privately held laboratory diagnostic company whose focus is to bring emerging technologies to market aimed at addressing antibiotic resistance and other world health issues. The company is currently seeking B Series investors to further expand its product offering and the commercialization of its proprietary RAPID-BTM platform. For investment opportunities, please contact Mr. David Potenza

Aperture Bio, LLC
20 Winter Sport Ln
Ste 150
Williston, VT 05495
David Potenza

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