Actionable NTM Answers for Clinical Trials — in Less Than 3 Days
NTM trials fail when the wrong patients are enrolled. NTM-Seq delivers elite species detection, genotypic resistance characterization, and no organism growth needed — direct from respiratory samples, in less than 3 days.
NTM Therapeutics Pipeline by Phase
Culture-based ID takes weeks. Trials can't wait.
Traditional NTM species identification relies on culture methods that take 4–12 weeks. For clinical trials with enrollment windows, treatment timelines, and endpoint integrity — that delay creates real risk for patient selection and data quality.
Typical wait for species-level ID via conventional culture — what most trial sites are using today.
Distinct NTM species with different treatment responses and resistance profiles. Genus-level ID is not sufficient for enrollment decisions.
NTM-Seq turnaround. Actionable species ID + genotypic resistance characterization, no organism growth needed.
NTM-Seq Results. One Test.
NTM-Seq powered by next-generation sequencing delivers everything your protocol needs — in a single test, directly from respiratory samples, faster than any culture-based method.
Elite NTM Species Detection
Identifies all clinically relevant NTM species and subspecies — including MAC complex members, M. abscessus subspecies, and rare isolates — from a single respiratory sample.
Genotypic Resistance Characterization
Goes beyond species ID to deliver genotypic resistance characterization — enabling smarter patient stratification and pre-specified subgroup analyses based on resistance profile.
No Organism Growth Needed
Works directly from respiratory samples — no weeks-long culture step required before sequencing. Actionable results in less than 3 days, before treatment decisions are made.
Trial-Grade Reporting
Structured, reproducible reports built for regulatory documentation, endpoint adjudication, and multi-site standardization.
→ Audit-ready dataMulti-Site Scalability
Centralized processing with standardized protocols — consistent results across all sites, eliminating inter-lab diagnostic variability.
→ Cross-site consistencyCLIA-Certified Lab
All testing performed in a CLIA-certified laboratory under rigorous QA/QC — compliant for clinical trial use and capable of supporting IND submissions.
→ Regulatory-grade confidenceWhere NTM-Seq fits your protocol.
From screening to endpoint, actionable molecular diagnostics change what's possible in NTM drug development.
Confirm species eligibility before randomization
Many NTM therapeutics in development are species-specific — and most trial sites still rely on culture identification that won't return results before the enrollment window closes. NTM-Seq delivers species confirmation in less than 3 days, letting you enroll the right patients with confidence.
MAC-targeted trials, M. abscessus studies, and any protocol with species-level eligibility criteria
Power subgroup analyses with precise baseline data
Species and subspecies differences drive meaningful variation in treatment outcomes. NTM-Seq provides the molecular baseline precision to pre-specify subgroups — revealing signal your primary endpoint might mask, without compromising randomization timelines.
Pre-specified subgroup analyses with well-characterized, molecularly confirmed baseline populations
Track microbiological response over treatment
Longitudinal NTM-Seq testing provides molecular-level visibility into culture conversion, species persistence, and potential co-infections — giving your trial a richer microbiological picture than colony count alone.
Serial quantitative results compatible with standard culture conversion endpoints
Eliminate inter-site diagnostic variability
Multi-site trials are undermined when different labs use different ID methods. Centralizing NTM identification through SeqDiagnostics gives every site the same gold-standard molecular result — protecting data integrity across geographies.
Single reference lab model with standardized methods across all trial sites
A growing pipeline requires diagnostic precision.
As targeted NTM therapies advance from Phase I through approval, the diagnostic standard must keep pace. Species-level accuracy at enrollment is the foundation of trial validity.
MAC — Inhaled Amikacin
The first approved therapy specifically for refractory MAC lung disease sets the standard: species specificity is baked into the label.
MAC — Oral Combination
Multi-drug oral regimens targeting MAC pulmonary disease, seeking improved tolerability over standard-of-care regimens.
MAC — Novel Inhaled
Next-generation inhaled delivery platforms targeting MAC lung disease with improved lung deposition profiles.
MAC — Oral Nano-Particle
Lipid nano-particle encapsulation enabling oral delivery of agents previously restricted to IV administration.
NTM — Immunomodulatory
Host-directed therapies enhancing innate immune response — a novel mechanism class distinct from traditional antibiotics.
M. abscessus — Novel Agents
Early programs targeting M. abscessus — one of the most resistant NTM species — using new small molecules and RNA-based platforms.
Ready to close the diagnostic gap?
Learn how NTM-Seq integrates into clinical trial workflows — from central lab setup to enrollment-day results. Our team works directly with clinical operations and medical affairs to design a protocol that fits your study.