Clinical Evaluation Results of Aperture Bio’s m.i.c.STAT Assay Shows Promising Improvements over Current Antibiotic Susceptibility Testing (AST): Time to Results, Throughput and Lower Costs

2019-07-23 12:28:51 - United States - (PR Distribution™)

In the latest series of proprietary in vitro tests developed to help address the growing Antibiotic Resistance (AMR) pandemic, clinical evaluations of Aperture Bio’s m.i.c.STAT assay, for antibiotic susceptibility (AST), show great promise. Early results have shown 100% accuracy in identifying resistance when compared to the clinical controls and tests are providing antibiotic guidance in an average of five (5) hours direct from a positive blood culture sample. When dealing with blood borne infections the accuracy and speed to effective antibiotic treatment is critical in improving patient outcomes and reducing the potential of propagating resistance. In a study published in Chest by Kumar A, Ellis P, Arabi Y, et al. in 2009: “If a patient receives antimicrobial therapy within the first hours of diagnosis, chances of survival are close to 80%. Survival is reduced by 7.6% for every hour after and if a patient initially receives inappropriate antimicrobial treatment, they are 5x’s less likely to survive.” According to Dr. Matthew Gombrich, Chief Medical Officer and co-founder of Aperture Bio, “We're incredibly encouraged by this early data. Multiple publications have supported the notion that time to results for antibiotic efficacy can decrease both mortality and overall healthcare costs.

Aperture Bio sees the m.i.c.STAT test, with its low cost, automation, and high-throughput capability as a real-world solution to getting bacteremic patients on an appropriate therapy much faster than current standards." Additionally, Dr. Gombrich added, "This early data has supported Aperture Bio's central thesis that applying highly accurate quantitative microbiology to patient care can improve turnaround time and potentially provide a new level of understanding therapeutic efficacy to treating physicians. The quantitative, multi-time point assessment that we employ in the test has the potential to add a kinetic component to understanding the in vitro effects of the antibiotic panel, which is novel. " Run on Aperture Bio’s RAPID-BTM platform, which offers high throughput at a relatively low cost per test, the company believes the m.i.c.STAT assay, with both Gram Positive and Gram Negative panels, could outpace current AST methods and redefine how antibiotic performance is assessed.

With faster “time-to-results” and high-throughput the platform offers a potentially significant advantage in improving related diagnostics and antibiotic treatment guidance throughout the world. Utilizing highly customized and fully robotic, Next-Gen flow cytometric technology (nFC) and fluidics, coupled with proprietary algorithms, chemistry and customized platting, the RAPID-BTM platform has proven to be highly accurate and fast in its specimen assessments. As a truly quantitative microbiology platform, the RAPID-BTM has the potential to rapidly and accurately assess other commercially available biomarker assays, including the NV-VPAC1TM cancer screening test by NuView Life Sciences, which is already under evaluation. In a statement from Aperture’s president, David Potenza, “Our testing has shown us that we are faster, cheaper and easier to deploy in commercial laboratories, providing greater access to world populations, potentially saving lives and making an impact on resistance.” Furthermore, Potenza states, “From a business perspective, the preliminary results of our m.i.c.STAT assay demonstrates our company’s potential to compete, and possibly disrupt, other well known, public companies that have already reached market valuations in excess of $1B dollars. This could be an exciting time for our investors” The company is already positioned to present its final submission to the FDA for its empiriSTAT-UTI assay developed for the rapid identification of bacterial infections in uncomplicated UTI’s.

The clinical evaluation results show the empiriSTAT-UTI assay can identify bacterial infections and pyuria from a urine sample in approximately 10 minutes and provide uropathogen confirmation with antibiotic guidance in approximately 3 hours - potentially cutting days from current standards of care. With the high rate of empiric antibiotic prescribing typically provided in a defensive response and a key contributor to AMR, may be attributed to slow and inaccurate POC and culture methods. This is where rapid assessment and guidance could make a difference. Providing data that is 98% sensitivity and 89% specific, the empiriSTAT-UTI could very quickly eliminate those patients that don’t need treatment, reducing overuse of antibiotics, and provide actionable guidance on the most effective antibiotics for those that do, impacting misuse. Once approved, this test could replace current urinalysis and culture methodologies, reducing the need for empirical prescribing of antibiotics and relieving pressure on increased antibiotic resistance. In addition, it could help reducing costs associated with over-testing and improve patient outcomes in general.

About Aperture Bio – Aperture Bio is a privately held laboratory diagnostic company with focus on bring emerging technologies to market aimed at improving outcomes and reducing the overuse and misuse of antibiotics. / Aperture Bio is currently seeking investors to further expand its product offering and commercialization of its proprietary RAPID-BTM platform. For investor opportunities, please contact Mr. David Potenza [email protected] or 1-(214)-707-8710

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