Delve Bio and UCSF Unveil Pioneering mNGS Study at American Society of Microbiology Microbe Conference
Delve Bio, a leader in metagenomic next-generation sequencing (mNGS) for infectious diseases, in partnership with the University of California, San Francisco (UCSF), today announced significant findings from a groundbreaking study. The research highlights the effectiveness and diagnostic capabilities of mNGS testing in identifying infectious meningitis, encephalitis, and myelitis in both adults and children. These results were presented at the American Society of Microbiology Microbe conference in Atlanta.
“Our seven-year experience at UCSF, reflected in these studies, demonstrates that mNGS is the most comprehensive, unbiased, and actionable tool for diagnosing infectious diseases,” said Dr. Charles Chiu, co-founder of Delve Bio, UCSF Professor of Laboratory Medicine and Infectious Diseases, and Director of the Clinical Microbiology Laboratory. “This data provides compelling insights into how mNGS can uncover the causes of complex central nervous system infections, facilitating timely management and treatment of these critical conditions.”
The study, led by Benoit et al., assessed over 4,800 patients who underwent cerebrospinal fluid (CSF) mNGS testing between 2016 and 2023. The results revealed that mNGS detected 797 organisms from 697 out of 4,828 samples (14.4%), representing 440 unique pathogen species. The study identified DNA and RNA viruses in nearly three-quarters of the cases, alongside a broad detection range of bacteria, fungi, and parasites.
Further analysis of all microbiological test results, including a clinical review of more than 1,000 patients treated at UCSF, showed that mNGS alone identified 21.8% (48 of 220) of infections. The sensitivity and specificity of CSF mNGS testing for clinically diagnosed infections were 63.1% and 99.6%, respectively, with a positive predictive value (PPV) of 97.1% and a negative predictive value (NPV) of 92.3%. As a single test, CSF mNGS exhibited a higher diagnostic yield (63.1%) compared to direct detection testing from CSF (45.9%), other samples (15.0%), and indirect serologic testing (28.8%) (P < 0.001 for all comparisons).
“Metagenomics represents the future of infectious disease diagnostics, allowing physicians to bypass the frustrating cycle of multiple tests for patients with severe neurological infections,” said Chris Garabedian, Venture Portfolio Manager at Perceptive Advisors. “These studies add to the growing evidence that metagenomic testing should be a standard part of diagnosing neurological infections. Delve Bio is committed to making this transformative technology widely accessible, enabling more physicians to achieve accurate diagnoses for their patients faster.”
Launched in June 2023, Delve Bio aims to commercialize mNGS technology initially developed at UCSF and exclusively licensed to Delve Bio. The company’s flagship service, Delve Neuro, includes state-of-the-art CSF testing with sequencing conducted in a CLIA-certified lab and comprehensive clinical decision support, promising a two-day turnaround. This service is poised to offer quicker, more thorough diagnoses for patients with severe neurological infections and is expected to be widely available later this year.
About Delve Bio, Inc.
Delve Bio is a metagenomic next-generation sequencing (mNGS) company that empowers laboratories and clinicians with the insights they need to confidently diagnose routine and rare infectious diseases, thereby minimizing the impact of harmful pathogens on humanity. By leveraging its unbiased, pathogen-agnostic mNGS platform, Delve Bio is able to identify a wide range of pathogens with a single test. Founded by world leaders in genomics and infectious disease Drs. Charles Chiu, Joe DeRisi, Michael Wilson, Pardis Sabeti and Matthew Meyerson, the company is backed by top institutional investors including Perceptive Xontogeny Venture Fund II, Section 32, and GV, along with leading individual investors.