Actionable NTM Answers for Clinical Trials in 2 to 3 Days
When a protocol has species-level eligibility criteria, enrollment depends on knowing the species. NTM-Seq reports species-level identification and genotypic resistance markers in 3 days direct from sputum or BAL, or in 2 days from positive cultures and isolates.
Culture-based ID takes weeks. Trials can't wait.
Species identification from culture typically takes 2 to 8 weeks. For trials with enrollment windows and species-level eligibility criteria, that wait delays screening and enrollment.
Typical time to species-level identification from culture.
NTM species assessed by NTM-Seq, with M. abscessus resolved to subspecies. Protocols with species-level eligibility need more than a genus-level result.
3 days direct from sputum or BAL, 2 days from positive cultures and isolates. Species-level ID and genotypic resistance markers in the same report.
NTM-Seq Results. One Report.
NTM-Seq uses targeted hybrid capture for NTM-Seq Direct and whole-genome sequencing for NTM-Seq Culture, reporting species-level identification and genotypic resistance markers together, so enrollment and stratification can work from the same result.
Species-Level Identification
170+ NTM species assessed, including M. avium complex members and M. abscessus resolved to subspecies (abscessus, massiliense, bolletii).
Genotypic Resistance Markers
Macrolide resistance markers including erm(41) sequevar, reported with the species ID. rrl and rrs launching Q4 2026. Supports pre-specified subgroup analyses by resistance genotype.
Direct From Specimen
NTM-Seq Direct runs on sputum or BAL with no culture step and reports in 3 days. NTM-Seq Culture reports in 2 days from positive cultures and isolates.
Structured Reporting
Every report follows the same fixed format: species, subspecies where applicable, and genotypic resistance markers, in the same fields for every specimen.
→ Same fields, every specimenCentral Lab Model
All trial specimens are tested in one laboratory under one protocol, so every site's results come from the same method.
→ One method across sitesCLIA-Certified Laboratory
Testing is performed in the SeqDiagnostics CLIA-certified laboratory. NTM-Seq is a laboratory-developed test and is not cleared or approved by the FDA.
→ CLIA-certifiedWhere NTM-Seq fits your protocol.
From screening to endpoint, actionable molecular diagnostics change what's possible in NTM drug development.
Identify species eligibility earlier in screening
Many NTM therapeutics in development target specific species, and eligibility is often established from culture, which can take weeks. An NTM trial investigator described patients who had an exacerbation while waiting on those results, and as a result could not start the trial. NTM-Seq reports species-level identification in 2 to 3 days, shortening the wait and speeding up enrollment. Where a protocol still requires culture, NTM-Seq can flag likely-eligible patients while culture runs.
MAC-targeted trials, M. abscessus studies, and any protocol with species-level eligibility criteria
Stratify by species, subspecies and resistance genotype
Species and subspecies are associated with differences in treatment response. This is clearest in M. abscessus, where subspecies and erm(41) status are associated with inducible macrolide resistance. NTM-Seq reports species, subspecies and resistance markers at baseline, so subgroups can be pre-specified by genotype.
Pre-specified subgroup analyses by species, subspecies and resistance genotype at baseline
Explore genotype changes during treatment
Serial NTM-Seq testing alongside culture can show which species are detected at each timepoint, including mixed infections.
An exploratory, qualitative measure alongside culture-based endpoints
One identification method across all sites
When trial sites use different identification methods, species calls can differ from site to site. Testing all trial specimens centrally with NTM-Seq gives every site results from the same method, in the same report format.
Central lab model with one method and one report format across all trial sites
Species-specific therapies need species-level answers.
NTM drug development increasingly targets specific organisms, such as M. avium complex or M. abscessus. Trials of these therapies need species identification at screening, and resistance genotype wherever it defines subgroups.
Ready to close the diagnostic gap?
Learn how NTM-Seq fits into a clinical trial workflow, from central lab setup to results in 2 to 3 days. Our team works with clinical operations and medical affairs to set up specimen collection, shipping and reporting for your study.