SpectraWave Microbiology Solutions is a culture-based diagnostic system that significantly improves upon and streamlines current testing in the hospital laboratory. This innovative system provides results in less than five minutes without the use of chemical reagents. Initially the system is being developed to identify bacterial pathogens from positive blood cultures.
SpectraWave Microbiology Solutions will initially address analysis needs in the blood culture market currently estimated to total more than $3 billion in the United States alone. Sepsis, the systemic response to microbial infections in the blood stream (bacteremia), is currently the 10th leading cause of death in the U.S. The critical treatment challenge is the extended time it takes to accurately identify the cause of sepsis. For each hour sepsis patients are on an ineffective antimicrobial therapy, their risk of mortality increases 7.6%. Among multi-drug resistant organisms (MDROs), Staphylococcus aureus is a leading cause of hospital-acquired bloodstream infections. The market opportunity for each new, innovative test for earlier identification of pathogenic bacteria like S. aureus is estimated to be more than $100 million.
This system is currently in clinical studies to demonstrate its accuracy in identifying and characterizing several bacterial pathogens from the same optical profile. By using the same optical profile to identify the cause of infection from an expanding menu of bacterial pathogens and characterize its antibiotic susceptibility within 5 minutes, SpectraWave Microbiology Solutions will put highly actionable information in the hands of healthcare workers to improve patient outcomes and quality of care while lowering the cost of care.
Actionable results in minutes, not hours: Results available in less than five minutes, at least 97.5% faster than current methods (Vitek, GeneOhm, Hemocue, etc.).
Reagentless: No preparatory, molecular, or immuno-reagents are required; no storage issues; no out-dating of reagents; no lot-to-lot variations in quality.
Efficient. Does not require other screening methods such as a Gram stain.
Superior information content: The identification of bacterial pathogens is based on an optical profile. From this profile, information specific about a pathogen can be extracted, including size, shape, particle density, chemical composition, and structural organization. Such information content is currently unavailable using a single conventional method. Identification and characterization will be available at the level relevant for clinical diagnosis, therapy selection, reimbursement and disease monitoring. Because this comprehensive approach goes far beyond pattern matching and biomarkers, identification is unaffected by minor genetic shifts and substantially less susceptible to the impact of epidemiological variations.
Highly cost-effective: SpectraWave eliminates the cost burden related to purchasing and storing reagents; it does not require the use of highly skilled professionals and will lead to decreased labor costs. These factors will contribute to increased laboratory profits. Faster, accurate results also mean shorter hospital patient stays and lower treatment costs.
Streamlined engineering: Units designed with commercially available components and are easy to maintain.
Fully automated on-demand units: No hands-on preparation time required. This walk away system runs samples on demand, singly, or batched.
Expanding pathogen identification menus: New assays launched annually and delivered electronically.
Scalable: Economic for both high- and low- throughput laboratories.
Portable: System components and functionality designed to bring the test to the patient or sample, including highly remote locations.