Biotia Gets First-Ever NY State Regulatory Approval for a Urine Infectious Disease Test Powered by Genomics and AI
NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Biotia, a leading innovator in genomic-based infectious disease diagnostics, announced a major milestone with New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) approval of its BIOTIA-ID Urine NGS Assay as a Laboratory Developed Test (LDT). BIOTIA-ID is the first genomics-based urine assay leveraging artificial intelligence (AI) approved by NY. Obtaining this approval is a testament to Biotia's commitment to meeting the rigorous standards set by the NYS Department of Health, which includes a thorough review of the analytical and clinical validation of the assay in Biotia's CLIA laboratory in Queens, NY. BIOTIA-ID now joins a select group of AI-powered genomic tests transforming the future of healthcare.
Urinary tract infections (UTIs) are the most common outpatient infection, affecting upwards of 7 million patients annually, and disproportionately impacting women. UTIs affect quality of life and cause serious health problems, with urogenital infections causing 30% of sepsis cases. The BIOTIA-ID test offers a rapid, highly accurate (97% sensitivity, 99% specificity), and comprehensive solution for identifying urogenital pathogens, including those often missed by traditional culture methods. BIOTIA-ID utilizes AI and genomics (i.e. shotgun metagenomic sequencing) for comprehensive pathogen detection, reducing false positives, and surpassing the limitations of culture, PCR and targeted 16S amplicon NGS testing, which often yield incomplete, unclear, or contradictory results.
"Precision infectious disease diagnostics is not just about improving individual patient care; it is about transforming the healthcare landscape," said Dr. Niamh O'Hara, CEO and Co-Founder of Biotia. "By providing accurate, detailed, and timely information, we can move towards a future where treatment is truly personalized and public health is protected."
A recent clinical study, presented at IDWeek 2024, demonstrated the high performance of BIOTIA-ID, reporting that the assay identifies pathogens in 60% of urine samples for whom traditional culture-based techniques fail. Alarmingly, 70% of these patients had been prescribed ineffective antimicrobials to the pathogens BIOTIA-ID identified. "This approval will enable us to offer access to this vital technology, ensuring that patients and clinicians in New York, and soon across the United States, have access to the most accurate and comprehensive diagnostic information available, with the ultimate goal of supporting the responsible use of antimicrobials and improving patient outcomes," said Dr. Dorottya Nagy-Szakal, Chief Medical Officer at Biotia.
Addressing a Critical Need for Complicated UTIs
The BIOTIA-ID test is particularly valuable for patients with complicated and recurrent UTIs, or for patients who are immunocompromised, who often face diagnostic challenges and delays in receiving appropriate treatment.
"Biotia's innovative UTI diagnostic is a potential step-change in how we manage these often challenging infections, including for the millions of women who suffer frequent urinary tract infections and take cycle after cycle of antibiotics for relief," said Dr. Christina Jenkins, Biotia investor, physician, and former health system executive. "Biotia's ability to rapidly and accurately identify a broad range of pathogens means patients receive the right medication, faster -- improving their experience, health outcomes, and promoting good antimicrobial stewardship in this age of growing drug resistance."
Biotia is actively working with leading medical institutions and laboratories to integrate its product into clinical workflows, and insurance providers to ensure that BIOTIA-ID is accessible to the widest patient population.
To learn more about Biotia's diagnostic product offerings, visit www.biotia.io, connect on Twitter, Facebook and LinkedIn.
Contact: media@biotia.io
About Biotia
Biotia is a health-tech company located in New York, NY, that leverages sequencing-based technology and proprietary AI-powered software to rapidly and accurately identify microorganisms and antimicrobial resistance. Their mission is to fight infectious diseases by deploying the leading reference library of microbes worldwide. As a spinout company of Jacobs Technion-Cornell Institute at Cornell Tech, Biotia has a New York State CLIA lab for infectious disease diagnostics testing affiliated with SUNY Downstate Health Sciences University.