A handheld, point-of-care breath analyzer using 4× Nanoz MEMS metal-oxide arrays, CO₂-gated alveolar sampling, and on-device AI — delivering 1-minute symptom-agnostic active TB case finding by ASHA community health workers at < USD 1 per test.
Today, TB diagnosis depends on patients self-presenting with symptoms and producing sputum — excluding women, children, and rural populations. We replace symptom-based triage with proactive, instrument-based screening at the community level.
Designed to be operated by ASHA community health workers without medical training — no lab, no sputum, no specimen logistics.
Lay-worker level · 18-hour curriculum covering 50 trainees before POC start.
No sputum · no biohazard waste · no cold-chain · no transport · no storage.
Traffic-light output (green/yellow/red) + quantitative TB probability · Bluetooth 5.0 to tablet.
12 sensing zones · 8 heater profiles per breath · ~1 164 features per patient · on-device XGBoost inference in < 100 ms.
4× Nanoz NZGS-2 MEMS metal-oxide arrays. 12 sensing zones, 8 heater profiles per breath. LoD ≥ 25 ppb acetone.
Sprint IR-R NDIR CO₂ sensor with sub-1-second alveolar phase gating. Only Phase-III breath data is analysed.
TSR proprietary ThermoAir 5.0 (TA5) thermal mass-flow sensor — 0.5 % accuracy (L/min · m/s). Cleanroom-calibrated ISO 14644 Class 5–6 · 24-bit high-end PCB.
XGBoost ensemble < 1 MB INT8. Federated learning across deployment sites. < 100 ms inference on STM32U5.
The Nanoz BA Series is not a "VOC sensor with extras" — it integrates six clinically-distinct measurement modalities, each capturing orthogonal patient information. The AI fusion engine uses the full 1 164-feature space to anchor disease classification.
TSR proprietary ThermoAir 5.0 (TA5) volumetric-flow sensor — thermal mass-flow measurement inside the heated sample path (no Pitot tube, no differential pressure). Captures airflow and velocity in real time across the whole breath cycle, same clinical target as a spirometer. Calibrated in TSR’s in-house cleanroom (ISO 14644 Class 5–6); read out via a proprietary 24-bit high-end PCB (vs. Nanoz standard 4–8 bit) for maximum signal resolution. The whole device is protected by the Milkyway2026 patent CH 000590/2026, privately held by Michael Scheller — the base technology behind all three projects.
| Accuracy (volumetric flow) | 0.5 % (L/min) |
| Accuracy (velocity) | 0.5 % (m/s) |
| Measurement principle | Thermal mass-flow (TSR proprietary) |
| Sample rate | 1 kHz (1 000 samples per second) |
| Derived parameters | FEV₁ · FVC · PEF · FEV₁/FVC ratio · breath volume |
| Clinical use | COPD severity (GOLD) · asthma · restrictive disease |
| Readout front-end | High-end 24-bit PCB (vs. Nanoz standard 4–8 bit) |
| Calibration environment | TSR in-house cleanroom · ISO 14644 Class 5–6 · traceable to ISO/IEC 17025:2018 |
Sprint IR-R solid-state NDIR sensor — sub-1-second response enables real-time identification of the alveolar Phase-III plateau (CO₂ ≈ 4 %). VOC data is harvested only from the alveolar window, eliminating dead-space and transition-phase contamination.
| Response time T₁‰₀ | < 1 s (10× faster than typical NDIR) |
| Range | 0–5 % CO₂ (option 0–20 %) |
| Sample rate | 20 Hz |
| Derived parameters | etCO₂ · capnogram waveform · α-angle · β-angle |
| Clinical use | Alveolar gating · COPD/asthma airway obstruction · pulmonary perfusion |
| Pre-chamber | 1 cm Aerogel block + Al cooling fins · 38 °C target |
4× Nanoz NZGS-2 MEMS metal-oxide chips (4 sensing zones each = 16 zones total) operated through 8 sequential heater-voltage profiles per breath. Each (zone × heater) combination generates a temporal response — yielding ~ 1 164 distinct features per patient.
| Sensing zones | 16 (4 chips × 4 zones) |
| Heater profiles | 8 sequential temperatures per breath cycle |
| Acetone LoD | 25 ppb (Diabetes T2 marker, threshold 900 ppb) |
| NH₃ response | 5× baseline @ 50 ppm (CKD marker, threshold 1 ppm) |
| Ethanol / Formaldehyde LoD | 30 ppb each (liver / lung-cancer markers) |
| Selectivity | Peer-validated PCA-discrimination CO/NO₂/O₃ on single WO₃ zone (Im2NP/CNRS) |
Sensirion T/RH integrated sensor — provides absolute temperature and humidity context for every breath. Critical for tropical-climate operation (Indian POC: 15–45 °C / 0–95 % RH). Without active compensation, MOx sensor drift would dominate the VOC signal.
| T accuracy | ± 0.2 °C |
| RH accuracy | ± 1.5 % |
| Operating range | −40 °C to +125 °C, 0–100 % RH non-condensing |
| Compensation algorithm | Multivariate AI correction across all 16 MOx zones |
| Validated tropical envelope | 15–45 °C / 0–95 % RH (Gujarat, May/June) |
| External Nanoz reference | Companion drift-anchor channel (auto-drift stack tier 1) |
POC phase (current): all breath data is uploaded encrypted to the TSR Cloud (Switzerland) — that is where the AI learns from every single patient and improves continuously. This is the prerequisite for the performance jumps from N = 25 000 → 500 000 → 5 M patients.
Commercial roll-out (post-CDSCO): the device runs autonomously with its own on-device AI (XGBoost ensemble < 1 MB INT8 on STM32U5 Cortex-M33, < 100 ms inference per breath). When internet is available it automatically receives new models from the cloud and pushes aggregated, anonymised learning data back. The device stays diagnostic-capable offline, but benefits from the growing data lake whenever it is online.
| POC phase | Encrypted cloud upload (TSR Cloud Switzerland) for model training |
| Commercial phase | Autonomous on-device AI · optional cloud sync for updates & data return flow |
| Model size (on-device) | < 1 MB INT8 quantised |
| Inference time | < 100 ms per breath |
| Hardware | STM32U5 Cortex-M33 with TrustZone |
| Output | Traffic-light (green/yellow/red) + quantitative disease probabilities |
| Data protection | DPDPA 2023 · Swiss FADP · GDPR · end-to-end encryption · pseudonymisation |
| Connectivity | BLE 5.0 to tablet · USB-C · Wi-Fi / 4G for cloud sync · ABDM Health ID compatible |
The combined VOC + capno + spirometry + environmental feature space is monitored for pre-clinical pattern signatures — Dr. Anil Nakum's clinical observation indicates that biomarker drift becomes detectable in breath 10–20 days before symptomatic onset. The AI's longitudinal-tracking head flags this trajectory before a patient becomes symptomatic.
| Detection horizon | 10–20 days pre-symptomatic (TB · COPD exacerbation) |
| Mechanism | Longitudinal AI delta-tracking on patient's own baseline |
| Output | "Watch" status — yellow flag for re-screening before clinical event |
| Patient adherence | Repeat screening at PHC interval — leverages Make-in-India low cost |
| Clinical use | Active case finding · COPD exacerbation early intervention · CHF decompensation |
Two-shift operation with 8 devices in parallel, GeneXpert MTB/RIF as gold-standard reference, ICMR & Government of Gujarat coordinated.
| VOC drift in tropical conditions | External Nanoz reference channel + AI drift correction. Residual < 0.04 %/week validated on the Nanoz MEMS-MOX sensor platform. |
| Enrollment delays | Two-shift operation across 4 sites. 2 backup sites identified through Dr. Nakum's 10+ Gujarat hospital network. ASHA pre-screening pipeline. |
| IEC approval timeline | Pre-submission consultations completed; full dossiers prepared; submissions Q3 2026. |
| Regulatory class transition | Device already CDSCO Class A registered (pulmonary respiratory screening device). TB-specific Class B/C update follows POC + ICMR data — no greenfield submission needed. |
| Inter-site variability | Federated learning preserves site-level patterns. Centralised monthly calibration protocol. |
Vertical integration: in-house diamond growth → quantum sensors → breath diagnostics — across Switzerland and India.
The same hardware (4× Nanoz NZGS-2, CO₂ gating, ThermoAir 5.0, T/RH) captures multi-modal physiological data. The dataset grows with each phase — and so does the number of classifiable indications.
Every encrypted breath uploaded to the TSR Cloud improves the model — and therefore the performance for future patients. Diagnostic accuracy is therefore not a fixed number, but a function of dataset size.
Explore the full Disease Universe — AUC trajectory across the data flywheel, ROC curves and confounder robustness for every indication.
Conservative model based on NTEP population reach & diagnostic-pyramid inversion. Scales with CDSCO fast-track approval (Q1 2028 / Q2 2028) and NHM integration.
| Indication | Detected per year | Impact |
|---|---|---|
| Tuberculosis | 200 000–500 000 cases | → 30 000–60 000 lives |
| Type-2 Diabetes | 5–10 M early-detected | → 100 000–250 000 CV deaths avoided |
| CKD (chronic kidney disease) | 10–20 M early-detected | → 50 000–100 000 ESRD delayed |
| Oral cancer (Stage I) | 30 000–50 000 Stage-I shifts | → 5-yr survival < 30 % to > 70 % |
| TOTAL INDIA | 205 000–457 000 lives per year | |
Conservative estimate — Phase 4 (global) adds an additional 2–5 M lives/year from 2030 onward.
Three patient groups poorly served by the existing sputum pathway — the BIRAC SPARSH follow-on grant (Q3 2026) focuses specifically on these.
After validated Indian mass-screening from 2028, the international roll-out begins — starting with the 5 highest-TB-burden Sub-Sahara countries, each anchored to a WHO/FIND partner.
Tech-adjusted simulation across 12 800 patients, PCA on 16 MOx zones, 8-class disease separation and ROC across 8 indications — the analytical groundwork before the 25 000-patient POC.
Conservative AUC-estimate from tech-adjusted simulation, with cross-referenced peer-reviewed baselines for each indication.
| Tuberculosis | AUC = 0.950 |
| Diabetes Type 2 | AUC = 0.965 |
| CKD | AUC = 0.940 |
| Liver cirrhosis | AUC = 0.965 |
| Lung cancer | AUC = 0.940 |
| Asthma | AUC = 0.930 |
| Oral cancer / OSMF | AUC = 0.920 |
| COPD | AUC = 0.890 |
Documented limits of detection & selectivity for the breath-relevant gases of the Milkyway BA Series — based on Nanoz datasheet, Im2NP / CNRS Marseille (ALLSENSORS 2020), and IUPUI breath-VOC studies.
All gases shown are atmospheric- & breath-relevant. Industrial / automotive gas-detection campaigns (battery thermal-runaway, EV in-cabin VOC monitoring with Stellantis & Renault) demonstrate sensor-platform reliability in harsh real-world conditions but are not part of the clinical use case.
We are not betting on an unproven sensor. The same Nanoz NZGS-2 architecture used in the Milkyway BA Series is already in three independent commercial & regulatory tracks — medical (USA FDA), industrial (EV automotive), and academic (peer-reviewed clinical research).
The clinical evidence for the Nanoz sensor platform is published and independently peer-reviewed — Maciel, Sankari, Woollam & Agarwal, IEEE Sensors Journal 2023. Measured on 1× Nanoz NZGS-2 at VH 2.0 V / VS 0.8 V.
Stated explicitly in our 28 April 2026 Gates Foundation Grand Challenges submission: TSR's 25 000-patient Phase-1 POC dataset will become a multi-disease validation reservoir for the entire Nanoz-sensor scientific community — directly supporting the Scosche Prevnt FDA-track programme.
Commercial Nanoz deployment for EV battery thermal-runaway early-warning and in-cabin VOC air-quality monitoring.
Six disease conditions validated on identical Nanoz architecture: hypoglycaemia, prostate cancer, breast cancer, cystic fibrosis, COVID-19, diabetes.
Prof. Khalifa Aguir — co-inventor of NZGS-2 architecture (US20160238548A1), 200+ MEMS-MOx publications, GADC Co-Investigator.
Scosche Prevnt is a registered product / programme operated by Scosche Industries (USA). Its mention here is for predicate-device context only. Milkyway2026 is an independent device line, not affiliated with Scosche Industries.
Comparison against established TB diagnostic methods and the two most relevant VOC competitors.
| Method | TB Sens | Multi-modal | POC? | $/test | $/device |
|---|---|---|---|---|---|
| Sputum microscopy | 50–60 % | ✕ | Lab | $2–5 | — |
| GeneXpert MTB/RIF | 85–89 % | ✕ | Semi | $10–15 | $17 000 |
| Truenat MTB Plus | 80–85 % | ✕ | Semi | $8–10 | $8 000 |
| Owlstone FAIMS | 80–85 % | VOC only | ✕ | ~$250 | ~$35 000 |
| Aeonose eNose | 76–84 % | VOC only | ✓ | ~$30 | ~$8 000 |
| ResApp cough audio | 79–86 % | audio only | ✓ | ~$5 | app |
| Milkyway BA (target) | 88–95 % | ✓ YES | ✓ YES | $0.85 | $800–2 000 |
Competitor sensitivities: peer-reviewed literature 2018–2024 · Milkyway BA target derived from v3.5 spec + 1 164-feature multi-modal fusion.
Stakeholder alignment completed at federal, state, and ICMR level prior to submission. Letters of Support are being formalized.
Member of Parliament (Rajya Sabha) and former Union Minister of Fisheries, Animal Husbandry & Dairying (2019–2024). Senior BJP leader anchoring federal political support for the GADC consortium and CDSCO Class B/C indication update.
Site-approval for 4 Gujarat hospitals · IEC-process acceleration · clinical-operations endorsement.
Make-in-India alignment · DVA ≥ 40 % confirmation · PLI-scheme eligibility for TSR Surat assembly.
Indian Council of Medical Research · trial-coordination commitment for ICMR-led multi-site phase from Q1 2027.
CDSCO Class A registration completed for the Nanoz BA Series · four parallel IEC submissions targeted Q3 2026 · TB-specific Class B/C update planned post-POC.
Submitted to "Innovations in Cost-Disruptive Tools for Diagnosis & Screening" — Application 0000001744 · 28 April 2026, 05:00 AM PDT.
Photo credits: TSR Group internal records · April 2026 · click any photo to view full size
CEO of TSR Messtechnik AG (Schaffhausen); Director and Co-Owner of TSRAI NANOZ Sensors Pvt. Ltd. (Surat). Private owner and inventor of the Milkyway2026 patent (CH 000590/2026) — the base technology of all three projects (Milkyway Breath Analyzer, SURAT-7B NV diamonds, Blue Elephant). Technical project lead, sensor-stack integration, cross-site coordination CH/IN/FR.
Professor Emeritus, Aix-Marseille Université, IM2NP-CNRS UMR 7334. Inventor of the Nanoz NZGS-2 sensor architecture (US20160238548A1). Nanoz S.A.S. shareholder; 200+ publications in MEMS-MOx microsensors.
R&D Director, Planterum Bioscience (Porbandar, Gujarat). 17+ years biotech leadership. 9 Indian patents covering HIV/AIDS, viral pathology, autoimmune & inflammatory disorders. 10 trademarks; pilot manufacturing facility.
Ph.D. Materials Science. TSRAI NANOZ Sensors Pvt. Ltd. Sensor-layer development, MEMS device characterization, ISO/IEC 17025 quality assurance.
Ph.D. TSRAI NANOZ Sensors Pvt. Ltd. Edge-AI and multi-modal classifier development; on-device inference pipelines.
Lecturer in CS, EE & Medical Technology, Hochschule München (HM). Device firmware, embedded software, IEC 60601 conformity engineering.
The device is manufactured by TSR Messtechnik AG, which operates a certified Quality Management System and an accredited Calibration & Testing Laboratory across its Swiss and Indian entities. These certifications are held by TSR Messtechnik AG.
A Foundation grant of ~USD 1.11 M anchors a complementary financing stack of EUR 9–19 M — bank facility, EIC Accelerator grant and equity round.
The range is driven by the size of the equity round. Status is stated per item: only the Foundation application has been filed to date — EIC and the equity round are in preparation and are not committed funds.
Open documentation for reviewers, partners, and clinical collaborators.
The Principal Investigator (M. Scheller) and one Co-Investigator (Prof. K. Aguir) hold equity stakes in Nanoz S.A.S. (France), supplier of the NZGS-2 MEMS sensors.
Sensor procurement follows arm's-length pricing benchmarked against fair market value and audited under ISO 9001:2015. Nanoz S.A.S. has no role in study design, patient enrollment, data analysis, or publication strategy. Disclosure shared with all four participating IECs prior to study commencement.
For partnership, clinical collaboration, regulatory inquiries, or technical due diligence — we welcome direct contact with the Principal Investigator.