The PhAST BC GN Panel delivers phenotypic susceptibility results in approximately 100 minutes for Enterobacterales and Acinetobacter spp. and 140 minutes for Pseudomonas aeruginosa, directly from positive blood cultures, across 15 antimicrobials
CAMBRIDGE, Mass., Sept. 23, 2026 (GLOBE NEWSWIRE) -- PhAST Corp., an in vitro diagnostics company building a single-cell computer vision platform for rapid phenotypic testing across clinical microbiology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the PhAST instrument and the PhAST Blood Culture Gram-negative Panel (PhAST BC GN Panel, K253316), granted June 2026.
The PhAST BC GN Panel is a phenotypic in vitro diagnostic assay that determines antimicrobial susceptibility directly from blood cultures flagged as positive by a continuous monitoring system, without subculture. The panel reports a categorical interpretation - Susceptible, Intermediate, or Resistant - for 15 antimicrobials, and is indicated for monomicrobial samples containing Acinetobacter spp., Enterobacterales, or Pseudomonas aeruginosa. Organism identity from a separate FDA-cleared method is required.
The PhAST BC GN Panel is the fastest FDA-cleared phenotypic antimicrobial susceptibility test for positive blood cultures. Time from sample loading to susceptibility results is 99 ± 6 min for Enterobacterales and Acinetobacter spp., and 141 ± 6 min for P. aeruginosa (mean ± standard deviation). PhAST uses single-cell, time-lapse video microscopy and computer vision to observe how individual bacterial pathogens respond to antimicrobials, rather than inferring resistance from genetic markers.
“By quantifying the full range of individual cell responses to an antibiotic, our platform reveals population susceptibility in minutes rather than days, and we see significant potential to extend this approach across clinical microbiology,” said Roman Stocker, PhD, co-founder and Chief Scientific Officer of PhAST.
The PhAST BC GN Panel is categorized as Moderate Complexity under CLIA. Sample preparation takes under one minute of hands-on time. “This is one of the easiest instruments that I have ever worked with! Workflow felt very smooth,” said a medical technologist at one of the clinical trial sites. Each PhAST instrument can process four samples concurrently, with random access, for a throughput of up to 12 samples per eight-hour shift.
Bloodstream infections are among the most time-critical conditions in hospital medicine. In the United States, the Centers for Disease Control and Prevention estimates that at least 1.7 million adults develop sepsis each year and at least 350,000 die during their hospitalization or are discharged to hospice. Worldwide, an estimated 1.14 million deaths in 2021 were directly attributable to bacterial antimicrobial resistance, according to the Global Burden of Disease analysis published in The Lancet.
Conventional susceptibility testing typically requires 24 to 48 hours after a blood culture flags positive, during which patients generally remain on empiric broad-spectrum therapy.
“The shift that gets the positive blood culture should be the shift that acts on it. This means less time on the wrong drug - for the patient, and for everyone downstream of the resistance we drive with broad-spectrum antibiotics,” said John (JT) Sauls, PhD, CEO of PhAST.
The clearance was supported by a clinical study at four sites, three of them U.S. clinical laboratories. The overall Categorical Agreement was 97.3%, with a major error rate of 0.9% and a very major error rate of 0.2%.
U.S. clinical laboratories interested in evaluating the PhAST instrument and PhAST BC GN Panel can contact PhAST at info@phast.ai.
About PhAST
PhAST Corp. is a healthcare technology company developing AI-powered computer vision diagnostic technology to combat antibiotic resistance. Founded in 2017 and headquartered in Cambridge, Massachusetts, with offices in Zurich (Switzerland) and Seoul (South Korea), PhAST uses single-cell imaging and computer vision to observe how individual bacterial cells respond to antimicrobials, producing phenotypic results in 100 minutes rather than the days required by standard-of-care, culture-based methods. The PhAST instrument and PhAST Blood Culture Gram-negative Panel received FDA 510(k) clearance in June 2026 and Breakthrough Device Designation in October 2025. The platform is being developed for additional sample types and diagnostic outputs. Learn more at https://phast.ai/.
Media Contact
Yangsook (Kimy) Kim
PhAST Corp.
press@phast.ai · 617-301-2014
