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Primers on the building blocks of breath analysis.

The key barrier to adopting breath analysis is fragmented knowledge across VOC biomarkers, analytical instrumentation, and sampling SOPs. These primers consolidate the essentials you need before designing a clinical study or a device development program.

01

VOC biomarkers — origin and meaning

Why do volatile organic compounds appear in breath? Endogenous metabolism, microbiome, oxidative stress, environmental confounders. Disease × VOC mapping table included. (JP article)

~12 min read
02

Analytical technologies — 12-way comparison

FAIMS, GC-MS, GC-IMS, SIFT-MS, PTR-MS, SESI, e-nose (MOS), MSS, NBT, optical (NIR/MIR/QCL), RF/THz: operating principle, sensitivity, speed, cost. (JP article)

~15 min read
03

Sampling & pre-analytical SOPs

Guidance from IABR and the Peppermint Initiative, plus practical notes on ReCIVA, Tedlar bags, and EBC. Fasting / mouth rinse / ambient VOC handling rules. (JP article)

~10 min read
04

Analysis pipeline & bias

Peak detection → normalization → batch correction → feature selection → ML → external validation, plus the bias sources and data-leakage traps that inflate AUC. (JP article)

~12 min read
05

Regulatory pathways

FDA 510(k)/De Novo/PMA and the 2025 LDT-rule vacatur, EU IVDR (2017/746) transition, and Japan's PMDA SaMD/IVD framework and senshin-iryo linkage. (JP article)

~11 min read
06

Key reviews & evidence base

A topic-indexed list of foundational breath-analysis reviews — Amann, Haick, de Lacy Costello, van der Schee and more — with DOIs/links. (JP article)

Reference index

What is breathomics / volatolomics?

Breathomics (also called volatolomics when the scope is extended beyond breath) is the field that explores volatile organic compounds (VOCs), aerosols, and microbial signatures in exhaled breath as non-invasive biomarkers for disease detection, treatment response, and metabolic state monitoring. Exhaled breath contains thousands of VOCs produced by endogenous metabolism, oxidative stress, the oral and gut microbiome, xenobiotic exposure, and uptake from the environment.

Whereas blood, urine, and tissue require invasive or semi-invasive sampling, breath can be collected repeatedly, painlessly, and at the point of care. This makes it uniquely attractive for early-cancer screening, infectious-disease screening in outbreak settings (e.g., GeNose C19 in Indonesia), ICU / perioperative monitoring, and metabolic disease follow-up. Large international initiatives such as the International Association for Breath Research (IABR) and the Peppermint Initiative work to standardize methods so that evidence across cohorts and platforms can be combined.

The central technical challenge is that breath VOCs are present at parts-per-billion to parts-per-trillion levels, require careful control of ambient contamination, and need robust cross-batch and cross-device normalization for clinical deployment. Each of the knowledge articles in this section is written with that challenge in mind.

Note: detailed articles are currently available in Japanese. English translations are planned for 2026 Q3; please subscribe to the newsletter to be notified.