Delve Bio and UCSF Publish Research Demonstrating Clinical Utility of Metagenomic Next-Generation Sequencing (mNGS) for Diagnosing Serious Neurological Infections

• Paper published in Nature Medicine includes real world experience diagnosing difficult-to-detect pathogens in challenging central nervous system infections
• Nearly 22% of infections were identified through mNGS testing alone, delivering greater diagnostic yield than other microbiological tests
• Technology to become more widely available with shorter turnaround time through company’s Delve Detect testing service

Delve Bio, a pioneer in metagenomic next-generation sequencing (mNGS) for infectious diseases, in collaboration with the University of California, San Francisco (UCSF), today announced Nature Medicine has published its study demonstrating the clinical utility of mNGS testing to identify difficult-to-detect pathogens among adults and children with serious central nervous system infections. Soon to be widely available through the company’s Delve Detect testing service, the study showed mNGS testing is more sensitive than direct-detection testing.

“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.”

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.

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.

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. For more information, visit www.delve.bio.

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“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 and founding director of the UCSF Center for Encephalitis and Meningitis.