A new study published in Nature Medicine demonstrates the clinical utility of metagenomic next-generation sequencing (mNGS) testing to identify difficult-to-detect pathogens among adults and children with serious central nervous system infections.
The study showed mNGS testing is more sensitive than direct-detection testing.
Delve Bio, in partnership with the University of California, San Francisco (UCSF), announced the research results in a Nov. 12 statement.
The study includes data from more than 4,800 patients who received cerebrospinal fluid (CSF) mNGS testing. Over the 7-year period, mNGS detected 797 organisms from 697 of 4,828 samples (14.4%) representing 437 unique pathogen species; DNA and RNA viruses were identified in nearly three-quarters of cases, as well as broad-based detection of bacteria, fungi, and parasites. Analysis of all microbiological test results and clinical adjudication of a subset of more than 1,000 patients who were treated at UCSF showed that 21.8% (48 of 220) of infections were identified by mNGS alone.
“These findings add to the drumbeat of support for including mNGS as a core tool in the clinical workup for CNS infections,” said Michael Wilson, M.D., Delve Bio co-founder, member of the Board of Directors, and founding director of the UCSF Center for Encephalitis and Meningitis. “mNGS provides an unbiased, complete and definitive tool to quickly rule in or rule out an infection, enabling more timely diagnosis and treatment for patients with meningitis and encephalitis.”
Delve Detect is the company’s flagship cerebrospinal fluid (CSF) testing service, offering sequencing in a state-of-the-art CLIA lab and robust clinical decision support with turnaround times of two days. Ultimately, Delve Detect will enable more patients with potentially life-threatening neurological infections to benefit from faster, more comprehensive diagnoses.
“Time is critical in identifying the cause of acute meningitis or encephalitis for appropriate management decisions,” says Kiran Thakur, M.D., Herbert Irving associate professor of neurology at Columbia University Irving Medical Center – New York Presbyterian Hospital. “mNGS testing of CSF may be able to speed the diagnostic process in challenging cases, enabling rapid treatment decisions and ultimately better outcomes. Implementation studies across use settings will help guide its use.”
Delve Bio launched in June 2023 to commercialize mNGS technology originally developed at UCSF and exclusively licensed to Delve Bio.