Analytical Chemist

FDA grants breakthrough device designation to urine ID/AST panel. The assay is designed to enable faster pathogen identification and susceptibility testing to guide UTI management. The FDA has granted breakthrough device designation to an investigational urine ID/AST panel, a direct-from-specimen platform intended to support the diagnosis of urinary tract infection (UTI) by providing pathogen identification and antimicrobial susceptibility results within hours.[1] The assay is designed to deliver phenotypic antimicrobial susceptibility testing (AST) directly from urine specimens, potentially shortening the time to actionable microbiology results compared with conventional culture-based workflows. Breakthrough device designation is granted to devices that provide for more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. With this designation, the development pathway for the urine ID/AST panel can benefit from accelerated review. "Urine is the highest-volume specimen type in nearly every clinical microbiology laboratory, and the conventional workflow hasn't fundamentally changed in decades: culture overnight, identify, then set up susceptibility testing and wait again," explained Sarah E. Turbett, MD, director for antimicrobial stewardship and a clinical microbiologist at Mass General Brigham in Boston, in a news release.[1] "A direct-from-specimen result would compress 2 to 3 days into a single shift. This has the potential to impact what the lab can offer the clinicians and patients that it serves." Investigational assay targets faster identification. Pattern Bioscience said the urine ID/AST panel is being developed to provide information typically obtained through urine culture, including the organism responsible for infection and its antimicrobial susceptibility profile. The company describes the assay as a rapid, direct-from-specimen test that detects, identifies, quantifies, and provides same-day phenotypic AST for pathogens in urine. The company said the urine ID/AST panel uses the same single-cell microbiology platform as its pneumonia ID/AST panel. Pattern received Breakthrough Device Designation for the investigational pneumonia assay in December 2021.[2] "Pneumonia and urinary tract infections (UTIs) are the 2 most common infection types that progress to sepsis, and with this designation Pattern now has breakthrough-designated programs for both," said Carey-Ann Burnham, PhD, CEO of Pattern Bioscience, in the news release.[1] "UTI sits at the intersection of 3 problems: urine specimens create the highest-volume workload in the clinical microbiology laboratory, UTI is a common infection type progressing to sepsis, and UTIs are one of the biggest drivers of antibiotic use. A direct-from-specimen answer addresses all 3." REFERENCES

Pattern Bioscience appoints David Barreca as Vice President of Sales. Commercial leader in diagnostics joins Pattern to build US sales organization as the company nears FDA submission of its breakthrough single-cell microbiology platform and launch of the Pneumonia ID/AST Panel. AUSTIN, Texas, July 27, 2026 - Pattern Bioscience, an innovator in rapid diagnostic technologies for bacterial infections, today announced the appointment of David Barreca as Vice President of Sales. Barreca joins as Pattern moves from clinical development toward FDA submission and commercial launch of its single-cell microbiology platform and first assay, the Pneumonia ID/AST Panel, and begins building the team that will bring its technology to clinical laboratories nationwide. Barreca brings more than 17 years of commercial diagnostics experience, with a career defined by building high-performing sales teams at innovative diagnostic startups. He recently built and led sales efforts for VITEK REVEAL at bioMérieux, following the company's acquisition of Specific Diagnostics in 2022, where he served as Vice President of Sales, and previously was Senior Director of Sales at GenMark Diagnostics ahead of its $1.8 billion acquisition by Roche in 2021. "Twice now, David has built the commercial teams that brought transformative microbiology platforms to market. As we approach FDA submission for our launch assay, David brings both discipline in building a sales organization and the credibility in the microbiology community to help our platform bring results to patients and clinicians," said Carey-Ann Burnham, PhD, Chief Executive Officer of Pattern Bioscience. Pattern's single-cell microbiology platform is the first and only culture-free, rapid phenotypic identification and susceptibility testing (ID/AST) platform designed to deliver clinically actionable results in hours, rather than the days required by traditional culture-based methods. The company recently shared new data across multiple presentations at ASM Microbe 2026. "I've spent my career bringing new microbiology diagnostics to market, and I've seen how long the field waits for tools that truly change patient care. Pattern is doing something genuinely different: combining ID, AST, and culture-level insight in a single, culture-free test, and delivering it in a fraction of the time. Joining right before launch is the kind of opportunity that doesn't come often, and I can't wait to get this platform into the hands of labs and clinicians," said David Barreca, Vice President of Sales at Pattern Bioscience. About Pattern Bioscience Pattern Bioscience aims to save lives by transforming how bacterial infections are diagnosed and improving global health by reducing the burden of antibiotic resistance. Its single-cell microbiology technology is the first and only culture-free, rapid phenotypic testing platform to deliver clinically actionable results in hours, compared to the days required by traditional culture-based methods. Pattern Bioscience is a privately held company based in Austin, Texas, and is led by veterans of the diagnostic industry with deep experience bringing new diagnostic technologies to market. For more information, visit pattern.bio. Forward-Looking Statements This press release contains forward-looking statements regarding Pattern Bioscience's product development, regulatory plans, and commercialization timeline, including statements about the Pneumonia ID/AST Panel and anticipated FDA submission and commercial launch. These statements are subject to risks and uncertainties, and actual results may differ materially. Pattern Bioscience's products are for Investigational Use Only; the performance characteristics of these products have not been established, and the products have not been cleared or approved by the FDA. Media Contact Kyle Fieleke