Acutis Diagnostics, a vertically integrated company serving the medical and pharmaceutical communities by providing rapid and reliable diagnostic insights that impact clinical decisions in infectious disease, announced today that it has received approval from the New York State Department of Health for its Acutis Reveal™ Urinary Tract Infection test.
Based on a custom designed microarray, the Reveal™ UTI can simultaneously test for the presence of 31 bacteria and fungi that are among the most common pathogens associated with such infections. With approval from the New York State Department of Health, Acutis will become the first laboratory that is able to offer such testing in all 50 states.
“This is a tremendous milestone as we expand our infectious disease footprint. The current pandemic has placed a bright spotlight on companies in the infectious disease market, and the ability for our R&D team to be the first in the nation to successfully go through the rigorous process of a New York approval illustrates the high scientific standards that we employ,” says Acutis CEO, Jibreel Sarij.
Impacting more than 150 million individuals each year, urinary tract infections (UTI) are the second most common infection observed globally. In the US, they account for over 10 million office visits, 3 million Emergency Department encounters and half a million hospitalizations, at a total cost of over $6 billion to the healthcare system yearly. Additionally, UTIs are a leading cause of infection-related hospitalization events in the elderly population. Studies have shown that by utilizing assays such as Acutis Reveal™ UTI, material improvements in overall healthcare costs can be achieved.
Acutis scientists previously presented some of the validation findings of the assay, which was developed on the Thermo Fisher Scientific QuantStudio™ platform, at the most recent meeting of the Association for Molecular Pathology. At that presentation, the Company detailed some of the rigorous testing required as part of the New York State approval process, including analyzing each individual assay against actual intact organisms for such specificity, sensitivity linearity and stability. In addition, the Acutis team designed a standardized extraction process for nucleic acids, which it has already employed in its current SARS-CoV-2 assay, thus allowing for improved yield and increased assay throughput.
Managing Director of Acutis Biosciences, David Goldberg explains, “We recognize the scientific progress that Acutis continues to make. This UTI assay will improve patient care as well as provide value for CRO and diagnostic partners. We anticipate further test approvals in both the infectious disease and genomics markets which will help to solidify Acutis’ position as an industry innovator.”
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