The technology provides rapid resistance profiling for recurrent or complicated infections and is approved for use in all 50 US states.
Biotia has launched BIOTIA-DX Resistance, an antimicrobial resistance profiling technology now integrated into the company’s BIOTIA-ID Urine Test. The assay is approved under the New York State Clinical Laboratory Evaluation Program and is available for clinical use across all 50 US states, according to a press release.
The assay enables pathogen detection and antimicrobial resistance prediction directly from urine samples. It is designed to assist clinicians in managing recurrent or complicated urinary tract infections (UTIs) by providing resistance insights at the time of diagnosis. This approach aims to guide antibiotic selection and reduce the use of empiric broad-spectrum therapy, the company states.
“For patients with chronic or complicated UTIs, the difference between empiric and informed therapy can be measured in days of suffering, avoided hospitalizations, and prevented complications. What makes this launch meaningful is that it is already in patients’ hands today. Through our CLEP-approved test, clinicians can act on rapid, accurate resistance prediction at the time of diagnosis—getting patients to the right antibiotic faster, and reducing the use of broad-spectrum agents that drive further resistance,” says Dorottya Nagy-Szakal, MD, PhD, chief medical officer, in a release.
Addressing Antimicrobial Resistance
Antimicrobial resistance (AMR) is identified by the World Health Organization as a major public health and development challenge. AMR is associated with approximately 1.27 million deaths globally each year and is projected to rise without improved diagnostics and stewardship. Biotia states that rapid resistance prediction from clinical samples is necessary to guide therapy and limit the spread of resistant pathogens.
The BIOTIA-DX Resistance tool was recently evaluated in the 2026 Critical Assessment of Massive Data Analysis (CAMDA) Antimicrobial Resistance Challenge. It achieved the highest prediction accuracy for the second consecutive year in the global benchmarking competition, which evaluates computational approaches on metagenomic datasets to predict resistance profiles.
“Winning CAMDA two years in a row is a powerful validation of our approach to antimicrobial resistance prediction. Our platform combines large-scale curated genomic references with machine learning models trained to recognize resistance signals across organisms, drug classes, and sample contexts. Consistency across two independent challenges—on different datasets and against the strongest computational teams in the world—shows that BIOTIA-DX Resistance is not just accurate, but robust and generalizable,” says David Danko, PhD, chief technology officer, in a release.
Clinical Availability
The technology is now embedded within the BIOTIA-ID Urine Test. In addition to its Clinical Laboratory Evaluation Program approval, the test is available for clinical use throughout the US. The company has previously collaborated with institutions such as the Mayo Clinic, Hospital for Special Surgery, and NASA to develop diagnostic and software solutions for identifying infectious disease threats.
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