AUSTIN, Texas, December 8, 2021 – Pattern Bioscience, Inc. has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Pneumonia Action Panel. The test uses Pattern’s Digital CultureTM technology to provide a fast and comprehensive diagnosis for patients hospitalized with severe pneumonia. Digital CultureTM combines machine learning and single cell analysis to provide pathogen identification (ID) and phenotypic antibiotic susceptibility (AST) information an order of magnitude faster than current tests.
The FDA Breakthrough Device Program helps patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening diseases. Submissions for devices designated as Breakthrough Devices receive priority review, meaning that they are placed at the top of the appropriate review queue and receive additional review resources, as needed. Under the program, the FDA will also provide Pattern with interactive communication regarding device development, clinical study design and other pre-submission topics.
Bacterial pneumonia is the leading cause of sepsis, and lower respiratory infections kill more people annually than any other infectious disease. With the SARS-CoV-2 virus now expected to remain in circulation after the pandemic, the need for rapid comprehensive testing in hospitalized patients is becoming more urgent.
There are an estimated 160,000 pneumo-sepsis deaths per year in the United States.1 Studies show that critically ill pneumonia patients experience treatment failure 20-25% of the time, resulting in significantly higher morbidity and mortality. Early and effective antibiotic treatment is vital for these patients,2, 3 but current tests take days to provide conclusive diagnosis of antibiotic resistance. Pattern’s test can provide a definitive diagnosis within hours, allowing clinicians to optimize antibiotics quickly to ensure effective treatment, prevent side effects, and reduce healthcare costs.
Pattern Bioscience is a privately held in vitro diagnostics company founded in 2016 to help combat the problem of antibiotic resistance. Pattern is developing a next-generation clinical microbiology platform based on its patented Digital CultureTM technology that can rapidly identify pathogens and determine their antibiotic response without the need for traditional time-consuming culture steps.
Digital CultureTM is a single cell analysis platform that uses digital cell reactors combined with machine learning to rapidly diagnose complex bacterial infections. The platform, which produces millions of measurements per run, will zoom into the real-time antibiotic response of individual bacterial cells within the first critical hours of illness. Pattern’s faster bacterial tests can reduce the risk of antibiotic misuse and enable focused treatment, improving patient outcomes and reducing selective pressures that lead to drug resistance.
The Pattern Pneumonia ID/AST Action Panel is in development and is not available for sale.
1 Lindenauer et al, Association of Diagnostic Coding With Trends in Hospitalizations and Mortality of Patients With Pneumonia, JAMA, 2012 Apr 4;307(13):1405-13. doi: 10.1001/jama.2012.384.
2 Iregui et al, Clinical Importance of Delays in the Initiation of Appropriate Antibiotic Treatment for Ventilator-Associated Pneumonia, CHEST, 2002 Jul;122(1):262-8. doi: 10.1378/chest.122.1.262.
3 Kollef et al, Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients, CHEST 1999 Feb;115(2):462-74. doi: 10.1378/chest.115.2.462.