T2 Biosystems, Inc. announced participation in the NIH-funded Antibacterial Resistance Leadership Group (ARLG) pilot study for pneumonia patients. The Pneumonia Direct Pilot study is a prospective, observational, diagnostic, feasibility study to determine the accuracy of multiple pathogen- and host-directed tests for the diagnosis of ventilator-associated pneumonia (VAP). Under the direction of Kimberly Hanson, M.D., University of Utah, the study seeks to explore new approaches for diagnosing VAP along with more comprehensive detection of antibiotic-resistant infections.

The feasibility design is intended to inform future interventional studies that will investigate the clinical impact of combined pathogen and host-directed testing approaches. In the pilot study, the FDA-cleared T2Bacteria® Panel and the T2Resistance® Panel, included as one of the pathogen directed platforms, will be evaluated for the ability to rapidly detect infections in the blood currently missed by conventional methods. The T2 sample testing for the multi-center study will be performed at Johns Hopkins Medicine laboratories.

The extremely low level of detection by T2 Biosystems? technology (?T2MR?) in whole blood (1 ? 11 CFU/mL) has been effective in detecting secondary infections.

Most recently, a 2022 publication1 in the journal Microbiology Spectrum evaluated the use of T2 Biosystems? sepsis tests in COVID-19 patients and found ?without the additional use of T2MR, 13.3% of candidemia and 10% of bacterial superinfections would have been missed.? Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections complicating critical care medicine.

Recent studies have reported that VAP affects between 5-40% of patients intubated for more than 2 days, with significant variation by county, intensive care unit (ICU), and criteria used to define the disease. Patients who develop VAP have prolonged durations of mechanical ventilation, increased lengths of ICU stay, and higher hospital costs. Poor outcomes are due, at least in part, to difficulties in making a diagnosis of VAP, which in turn delays the initiation of appropriate antibiotic therapy.

The clinical criteria suggestive of VAP are non-specific and standard microbiologic testing does not definitively separate airway colonizers from invasive pathogens. The resultant diagnostic uncertainty is a major driver of unnecessary antibiotic use and potentially antimicrobial resistance in the ICU5,. Furthermore, selecting effective empiric therapy for VAP is also complicated because multidrug-resistant pathogens may be isolated in early-onset VAP (i.e., within the first 4 days of hospitalization) as well as in late-onset cases.