Pattern Bioscience Receives FDA Breakthrough Device Designation for Urine ID/AST Panel
Pattern Bioscience, a company developing rapid diagnostic technologies for bacterial infections, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its investigational Urine ID/AST Panel. The designation represents another regulatory milestone for the company as it works to develop rapid, direct-from-specimen diagnostic solutions designed to provide clinicians with actionable information about bacterial infections and antimicrobial susceptibility on the same day.
The Urine ID/AST Panel is Pattern Bioscience’s second diagnostic program to receive FDA Breakthrough Device Designation. The company’s Pneumonia ID/AST Panel previously received the designation, giving Pattern breakthrough-designated programs focused on two major bacterial infection categories associated with progression to sepsis.
Pattern said the designation supports its broader strategy of developing a menu of rapid diagnostic assays that operate on a common single-cell microbiology platform. The company’s goal is to provide laboratories and healthcare professionals with information that traditionally requires conventional culture-based workflows and multiple days of processing.
The FDA Breakthrough Devices Program is intended to support the development and regulatory review of medical devices that have the potential to provide more effective diagnosis or treatment for patients with life-threatening or irreversibly debilitating conditions. The program is designed to facilitate development and expedite review while maintaining applicable regulatory standards.
Importantly, Breakthrough Device Designation does not mean that a device has received FDA clearance or approval. Pattern’s Urine ID/AST Panel remains investigational and is not currently available for commercial sale. Pattern Bioscience’s products are for Investigational Use Only and have not been cleared by the FDA.
Addressing a Major Diagnostic and Antibiotic Use Challenge
Urinary tract infections (UTIs) are among the most common bacterial infections and are a major reason antibiotics are prescribed in the United States. The large number of suspected and confirmed infections creates a significant workload for clinical microbiology laboratories while also contributing to antimicrobial use.
The conventional diagnostic pathway for a suspected bacterial UTI generally relies on urine culture. While culture remains an established method for identifying bacterial pathogens and determining antimicrobial susceptibility, results may take days to become available.
In many cases, treatment begins before definitive laboratory results are returned. Clinicians may initiate empirical antibiotic therapy based on symptoms and other clinical information while waiting for culture results. When a culture ultimately identifies a pathogen and provides susceptibility information, therapy can then be adjusted when necessary.
Pattern Bioscience said this process creates several challenges. A substantial proportion of urine cultures are negative, meaning some patients may receive antibiotics that could potentially have been avoided or discontinued earlier. When cultures are positive, the time required to identify the causative organism and determine its antimicrobial susceptibility can delay selection of the most appropriate treatment.
The company is developing the Urine ID/AST Panel to address this diagnostic gap by providing information directly from urine specimens without requiring the traditional culture workflow.
Carey-Ann Burnham, PhD, Chief Executive Officer of Pattern Bioscience, said UTIs represent an important area for rapid diagnostic innovation because they intersect with several major challenges facing healthcare systems.
According to Burnham, urine specimens represent the highest-volume workload in clinical microbiology laboratories, UTIs are among the infection types that can progress to sepsis, and these infections are significant drivers of antibiotic use. A direct-from-specimen diagnostic result, she said, has the potential to address these issues simultaneously.
Second Pattern Program to Receive Breakthrough Designation
The FDA designation for the Urine ID/AST Panel follows the Breakthrough Device Designation previously granted to Pattern’s Pneumonia ID/AST Panel.
Pattern said pneumonia and UTIs are two of the most common infection types that can progress to sepsis. Having breakthrough-designated diagnostic programs in both areas reflects the company’s strategy of targeting high-volume bacterial infections where rapid identification and antimicrobial susceptibility information could potentially affect clinical decision-making.
The two programs are based on the same single-cell microbiology platform. Pattern is developing the technology to provide direct-from-specimen identification and antimicrobial susceptibility testing without requiring the prolonged culture process used in conventional microbiology laboratories.
The approach is intended to move diagnostic information from a multistep workflow that can extend over several days toward a same-day process.
For clinical laboratories, reducing turnaround time could have implications for workflow and communication with treating physicians. Instead of waiting for sequential culture, identification and susceptibility results, laboratories could potentially provide key diagnostic information within a single clinical shift if the technology ultimately receives the required regulatory authorization.
From Two to Three Days Toward Same-Day Results
Sarah E. Turbett, MD, Director for Antimicrobial Stewardship and a clinical microbiologist at Mass General Brigham in Boston, highlighted the volume of urine testing handled by clinical microbiology laboratories.
She noted that urine is the highest-volume specimen type in nearly every clinical microbiology laboratory and that the conventional workflow has remained largely unchanged for decades. Under the traditional process, laboratories culture specimens, identify organisms after growth and then conduct antimicrobial susceptibility testing, with additional waiting time between steps.
A direct-from-specimen approach could potentially compress a process that traditionally takes two to three days into a single work shift, according to Turbett.
Such a reduction in turnaround time could affect what diagnostic information laboratories are able to provide to clinicians and patients. Faster results could also allow treatment decisions to be reconsidered sooner, although the ultimate clinical impact will depend on the performance of the investigational assay and its eventual regulatory status.
What the Urine ID/AST Panel Is Designed to Provide
Pattern Bioscience’s Urine ID/AST Panel is designed to provide two key pieces of information that clinicians commonly rely on culture testing to obtain.
The first is identification of the organism responsible for the infection. The second is antimicrobial susceptibility information showing which antibiotics are likely to be effective against the identified pathogen.
The investigational panel is designed to detect, identify and quantify bacterial pathogens directly from urine specimens. It is also designed to provide phenotypic antimicrobial susceptibility testing on the same day.
This combination is intended to go beyond simply detecting bacterial material. By incorporating phenotypic antimicrobial susceptibility information, the technology is designed to help determine how the identified organism responds to available antibiotics.
Pattern said its technology uses a single-cell microbiology platform to generate these results directly from patient specimens.
The company describes its Pneumonia ID/AST Panel as the first and only direct-from-specimen platform designed to provide organism identification and antimicrobial susceptibility results in hours rather than the days required by conventional culture. The Urine ID/AST Panel extends this platform approach into urinary tract infections.
Potential Role in Antimicrobial Stewardship
The development of rapid UTI diagnostics is closely connected to antimicrobial stewardship. Antibiotic treatment for suspected bacterial infection is often initiated before laboratory confirmation is available, particularly when clinicians believe delaying treatment could present risks to the patient.
However, empirical treatment can result in antibiotic exposure when an infection is not ultimately confirmed or can involve an antibiotic that does not provide optimal coverage for the causative organism.
Faster diagnostic information could potentially allow clinicians to make treatment decisions earlier in the course of care. For patients with confirmed bacterial infections, rapid susceptibility information could support selection or adjustment of antibiotics. For patients whose suspected infection is not confirmed, earlier diagnostic information could potentially support decisions about whether continued antibiotic therapy is appropriate.
Pattern’s technology is being developed with this broader diagnostic and stewardship challenge in mind. The company said a direct-from-specimen answer could help address the high volume of urine testing, the clinical risks associated with bacterial infections progressing to severe disease and the substantial use of antibiotics associated with UTIs.
Regulatory Milestone for Pattern’s Diagnostic Platform
The FDA Breakthrough Device Designation provides Pattern with an important development milestone as it advances the Urine ID/AST Panel through clinical and regulatory development.
The designation is intended to facilitate interaction between the FDA and developers of certain promising medical devices while supporting an efficient development and review process. However, the designation does not represent a determination that the device is safe or effective, nor does it constitute FDA clearance or approval.
Pattern will therefore need to continue its clinical, technical and regulatory development work before the Urine ID/AST Panel could potentially become commercially available.
For now, the panel remains an investigational technology. Pattern’s products are for Investigational Use Only and have not been cleared by the FDA.
The designation nevertheless strengthens the company’s broader effort to build a rapid diagnostic menu around its single-cell microbiology platform. With breakthrough-designated programs covering both pneumonia and urinary tract infections, Pattern is focusing on infection types where faster organism identification and antimicrobial susceptibility information could have significant clinical relevance.
As the company continues development of the Urine ID/AST Panel, future clinical and regulatory milestones will help determine whether the technology can deliver on its intended goal of replacing lengthy culture-based workflows with rapid, direct-from-specimen diagnostic results.
About Pattern Bioscience
Pattern Bioscience aims to save lives by transforming how bacterial infections are diagnosed and to improve global health by reducing the burden of antibiotic resistance. Its single-cell microbiology technology is the first and only direct-from-specimen, 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.