Delve Bio Announces Clinical Data on the Use of Metagenomic Next-Generation Sequencing (mNGS) to Identify Pathogens Causing Central Nervous System Infections

• In a study of more than 4,800 patients over seven years, mNGS testing detected pathogens in nearly 15% of samples, encompassing more than 440 unique pathogen species
• Nearly 22% of infections were identified through mNGS testing alone, which offered higher diagnostic yield than other microbiological tests

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 data from a study highlighting the utility and diagnostic yield of mNGS testing in cases of infectious meningitis, encephalitis, and/or myelitis among both adults and children at the American Society of Microbiology Microbe conference in Atlanta.

“Our experience over the seven years at UCSF covered in these studies shows that mNGS delivers the single most conclusive, unbiased and actionable tool for the diagnosis of infectious diseases,” said Charles Chiu, M.D., Ph.D., Delve Bio co-founder and UCSF Professor of Laboratory Medicine and Infectious Diseases and Director of the Clinical Microbiology Laboratory. “These data offer a compelling look at our real-world experience of using mNGS to uncover the cause of difficult-to-diagnose central nervous system infections to guide timely management and treatment for these life-threatening conditions.”

The study by Benoit, et al. presented at the conference evaluated more than 4,800 patients, who received cerebrospinal fluid (CSF) mNGS testing between 2016 and 2023. Overall, mNGS testing detected 797 organisms from 697 of 4,828 samples (14.4%) representing 440 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. The sensitivity and specificity of CSF mNGS testing with clinically diagnosed infection were 63.1% and 99.6%, respectively, with a positive predictive value (PPV) of 97.1%, and negative predictive value (NPV) of 92.3%. As a single test, CSF mNGS exhibited higher diagnostic yield (63.1%) than all direct detection testing from CSF (45.9%), direct detection testing from samples other than CSF (15.0%), and indirect serologic testing (28.8%) (P < 0.001 for all 3 comparisons).

“Metagenomics is the future of infectious disease diagnostics, enabling physicians to avoid frustrating cycles of testing for patients battling serious neurological infections,” said Chris Garabedian, Venture Portfolio Manager, Perceptive Advisors. “These studies add to the body of evidence that shows metagenomic testing should be part of routine diagnosis for patients with neurological infections. Delve Bio is working to make this transformative technology more widely available, which will ultimately enable more physicians to get to the right diagnosis for more patients faster.”

Delve Bio launched in June 2023 to commercialize mNGS technology originally developed at UCSF and exclusively licensed to Delve Bio. The company’s flagship cerebrospinal fluid (CSF) testing service, Delve Neuro, includes sequencing in a state-of-the-art CLIA lab and robust clinical decision support in a service that provides turnaround times of two days. Ultimately, Delve Neuro will enable more patients with potentially life-threatening neurological infections to benefit from faster, more comprehensive diagnoses. Delve Neuro is expected to become more broadly 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. For more information, visit www.delve.bio.

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