Condition: Central Nervous System Infection · Sponsor: Delve Bio, Inc.
Delve Bio, Inc. is a developer of novel mNGS tests with the goal of aiding in the diagnosis of infectious diseases in several clinical indications that may not have alternative traditional diagnostic methods routinely available. A proof of concept for the clinical utility of this mNGS testing methodology has been described in several seminal publications.1,2,3,4 Delve Bio is currently offering one of these assays as a laboratory-developed test (LDT) performed in a CLIA-certified, CAP-accredited laboratory. The test is called Delve Detect CSF. Delve Detect CSF is an mNGS in vitro diagnostic test intended for the simultaneous detection and differentiation of nucleic acids from multiple bacteria, viruses, fungi, and parasites in CSF from individuals suspected of meningitis or encephalitis. Delve Detect CSF identifies microbial nucleic acid in an unbiased and pathogen-agnostic manner. Historically, due to its cost and turnaround times, which can be on the order of 14 days, CSF mNGS testing is typically employed as a "test of last resort" for patients with suspected infectious meningitis and encephalitis, and is often used when traditional diagnostic methods cannot identify the cause of infection. In the IMPACT Study, we seek to investigate the diagnostic and clinical utility of mNGS testing if it is employed earlier in the diagnostic workup of patients with suspected CNS infection and unknown etiology in conjunction with a more rapid turnaround time for test results on the order…
This description comes directly from the study's public registry record.
Steve Miller, M.D., Ph.D. · 844-221-7423 · steve.miller@delve.bio
Timothy Blicharz, Ph.D. · tim.blicharz@delve.bio
Always discuss trial participation with your own doctor first.
| University of California at San Francisco at Zuckerberg San Francisco General | San Francisco, California, United States | Not Yet Recruiting |
| Emory University Hospital | Atlanta, Georgia, United States | Recruiting |
| Lahey Hospital & Medical Center | Burlington, Massachusetts, United States | Not Yet Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07435649