If you find yourself dealing with bladder leaks or pain when you go to the bathroom, it may be a sign of a urinary tract infection (UTI). Sometimes, however, it can be difficult to determine if your symptoms are related to a UTI or another vaginal-related infection. Now, for the first time, Biotia -- a leader in genomic-based infectious disease diagnostics -- has received NY state approval for a UTI test powered by genomics and AI that could help those suffering from chronic infections get the relief they seek. Keep reading to learn more about the test and who can benefit.
Details regarding the new AI UTI test
Biotia, alongside the New York State Department of Health Clinical Laboratory Evaluation Program, recently announced a breakthrough for urinary infectious diseases, especially UTIs. The company received approval for its BIOTIA-ID Urine NGS Assay as a Laboratory Developed Test, the first genomics-based urine assay.
UTIs are one of the most common infections, affecting upwards of seven million people yearly, with women most often experiencing symptoms. These infections can lead to other health issues, impact the quality of sleep and can result in sepsis or other more severe conditions if left untreated.
What the BIOTIA-ID UTI test measures
While other UTI tests, including home tests, are convenient, they have a higher chance of producing false positives and false negatives. Urine cultures take one to three days and urine dipsticks aren't always the most accurate. This new type of UTI test is said to be quick and more accurate (97% sensitivity, 99% specificity) and can identify urogenital pathogens that are often missed by other culture tests.
"Precision infectious disease diagnostics is not just about improving individual patient care; it is about transforming the healthcare landscape," Niamh O'Hara, PhD, CEO and Co-Founder of Biotia told PR Newswire. "By providing accurate, detailed, and timely information, we can move towards a future where treatment is truly personalized and public health is protected."
Where to get this new AI UTI Test?
Since its approval, Biotia has been actively working with medical institutions and laboratories to integrate the BIOTIA-ID test into workflows and insurance providers to ensure it is available to as many people as possible.
O'Hara says it is currently available for ordering by your clinician in New York when you experience symptoms. "We are working with partners to make it available soon for patients and clinicians across the United States."
Who can benefit from this type of UTI test?
While anyone experiencing UTI symptoms will benefit, the Biotia test is particularly helpful for patients with chronic recurring or complicated UTIs and those who are immunocompromised or who face diagnostic challenges and delays in receiving appropriate treatment.
"It is important to note that the BIOTIA-ID test isn't built for routine UTIs, which are often treated empirically (i.e. using antibiotics without knowing the cause of the infection), but is developed for complicated or recurrent UTIs," explains O'Hara. "Complicated and recurrent UTIs can profoundly affect the quality of life and cause serious health problems, with urogenital infections causing 30 percent of sepsis cases."
BIOTIA-ID study results
The BIOTIA-ID UTI test is already helping people diagnose their infections. A recent clinical study for the BIOTIA-ID was presented at ID Week 2024. Results demonstrated the high performance, sharing that the assay identifies pathogens in 60 percent of urine samples for whom traditional culture-based techniques fail. Surprisingly, most of the patients in the trial had been prescribed ineffective antimicrobials for the pathogens the Biotia test classified.