• In the largest study of its kind, the diagnostic yield of mNGS was greater than conventional test methods
• mNGS alone identified 34% more pathogens than all direct-detection methods combined
• 72% of pathogens detected by mNGS would have been missed by multiplex panel testing
• Data presented at the Association for Molecular Pathology 2024 Annual Meeting

Delve Bio, a pioneer in metagenomic next-generation sequencing (mNGS) for infectious diseases, today announced data from a seven-year study showing mNGS delivered the highest diagnostic yield of any test, identifying more pathogens than all other methods of direct organism detection (culture, antigen testing, PCR) combined. The findings were presented at the Association for Molecular Pathology 2024 Annual Meeting in Vancouver, B.C.

The study is the largest of its kind, including more than 4,800 patients who received mNGS testing on cerebrospinal fluid samples along with conventional microbiological testing. A wide array of DNA viruses, RNA viruses, bacteria, fungi and parasites were among the more than 430 different pathogens found through testing. In a subanalysis of 1,164 patients that did not receive multiplex panel testing prior to mNGS, the study found that 72% of pathogens detected through mNGS would have been missed by traditional panel testing for infectious meningitis and encephalitis.

“This study found nearly 3 in 4 pathogens detected by mNGS would have been missed by a widely used meningitis/encephalitis multiplex panel. Every additional test becomes a delay in the timely management and treatment for these life-threatening conditions,” said Steve Miller, M.D., Ph.D., chief medical officer at Delve Bio. “By opting to use mNGS testing, clinicians can order one test on one sample and detect all potential pathogens that could be causing an infection, limiting the time and expense associated with serial targeted testing.”

The study included 4,828 cerebrospinal fluid (CSF) samples that were tested using mNGS in addition to standard testing between 2016 and 2023. The study was designed to specifically compare mNGS to conventional testing for pathogens commonly associated with meningitis and encephalitis.

“These data highlight the breadth of potential pathogens behind meningitis and encephalitis. As we’ve seen in other areas of genetics, panel testing is limited compared to the biological diversity among patients in the clinic,” said Brad Murray, chief executive officer at Delve Bio. “Metagenomic testing should become part of routine diagnosis for patients with serious neurological infections. Our Delve Detect CSF testing service has been designed to increase access to this transformative technology by providing clinicians with a testing service that delivers results in 48 hours with the comprehensive clinical consultation and support needed to act on the results.”

Detailed findings from the study will be presented as part of Delve Bio’s scientific presence at the meeting, which includes the following poster presentations:

• Friday, November 22nd, 9:15am – 10:15am PT: Comparison of Diagnostic Coverage of Hypothesis-Free Metagenomic Sequencing vs. Multiplex PCR Testing for the Detection of Pathogens in CSF. Infectious Diseases Poster #ID025
• Saturday, November 23rd, 9:15am – 10:15am PT: Metagenomic Next Generation Sequencing (mNGS) Assay for Pathogen Detection in Cerebrospinal Fluid (CSF): Research & Development of an Optimal Background Matrix for Assay Performance Assessment. Infectious Diseases Poster #ID036

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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“By opting to use mNGS testing, clinicians can order one test on one sample and detect all potential pathogens that could be causing an infection," said Steve Miller, M.D., Ph.D., chief medical officer at Delve Bio.