Acutis Biosciences, a division of Acutis Diagnostics, announced today that its scientific presentation and publication, “Clinical Evaluation of a Robust Custom-Designed Multiplexed qPCR Microarray for Urinary Tract Infections” will be the subject of both a poster presentation at the upcoming Association for Molecular Pathology meeting, as well as an abstract in the November 2019 issue of The Journal of Molecular Diagnostics. Acutis scientists validated 30 individual molecular assays covering the most common causative agents of urinary tract infections, including both bacteria and fungi, achieving 100% specificity and over 96% sensitivity with 96% accuracy when compared with culture. The rigorous validation process that was used by Acutis is the subject of the presentation.
“We are very excited to announce the details of our first infectious disease developmental project and are honored to be selected to present our research at AMP,” said David Goldberg, Managing Director of Acutis Biosciences. UTIs are some of the most common bacterial infections, affecting some 150 million individuals globally. Thus, there is a need for a robust, economic and rapid assay that can pass a rigorous analytical and clinical validation process.
This publication demonstrates the expertise in biomarker and assay development assembled at Acutis Biosciences. “We look forward to expanding our reach with diagnostic and pharmaceutical partners, as well as to the commercial roll out of this assay in 2020,” he continued.
Added Dr. Mayil Shanmugam, Director of Research and Development at Acutis Biosciences and Lead Author of the publication, “Our assay is one of the first multiplexed PCR products to undergo the level of rigor that we have utilized during the development process. After working out the design parameters of the array, we then analyzed each individual assay against actual intact organisms for sensitivity, specificity, linearity, interference and stability as well as running check boarding titration experiments. Our theoretical limit of detection calculation was shown to match the actual assay performance for each and every organism we evaluated, thus demonstrating a robust assay design. We also developed a standardized nucleic acid extraction process which we can utilize across a wide range of other applications.” The work performed by Acutis Biosciences also furthers protocols and validation standards for other ongoing research work at the laboratory.
Acutis Biosciences, a member of the Acutis Family of companies, is a provider of biomarker-based analysis, as well as expert assay development and robust data analytics. Acutis Biosciences leverages the clinical expertise of Acutis Diagnostics and its work in analyzing more than 500,000 patient samples and tens of millions of data points. Our team of scientists have established laboratory developed tests across molecular, microbiology and metabolomic platforms.
For further information, please visit www.acutisbiosciences.com