ChromX Advances Clinical Application of Breath-Based VOC Analysis with Next-Gen Technology Following FDA’s First-Ever Authorization of a Breath Test for COVID-19

The FDA has long served as a bellwether for innovation in the global healthcare sector. Recently, the FDA granted Emergency Use Authorization (EUA) for the first COVID-19 diagnostic product based on the analysis of volatile organic compounds (VOCs) in exhaled breath. Developed by InspectIR, the device is approximately the size of a standard suitcase and can be deployed in various settings, including hospitals, physician offices, public spaces, and mobile testing stations. It requires only a breath sample and delivers results in under three minutes.

With the FDA’s approval of the first breath test for COVID-19, confidence and recognition of breath testing have significantly increased among clinical practitioners, industry stakeholders, and investors.

Recently, VCBeat held a dialogue with Dr. Wang Junqi, founder of ChromX Health. Dr. Wang holds a Ph.D. from the University of Michigan and completed his postdoctoral research at Yale University. He possesses extensive theoretical knowledge and R&D experience in micro gas chromatography technology, as well as the entire process of VOC collection, separation, and detection. He pioneered the development of wearable VOC detection devices.

Dr. Wang Junqi stated, “Regarding COVID-19 testing, clinical sample results from follow-up studies in the United States have shown that the specificity and sensitivity of ChromX Health’s POCT breath test product are on par with those of InspectIR, which has been approved by the FDA. Secondly,”COVID-19 testing is far from the endpoint for breath volatile organic compound (VOC) detection. According to the “Human Breathomics Database” published by Oxford Academic, breath VOC analysis can detect more than 60 diseases.”

Exhaled breath contains complex VOC profiles, and its clinical applications span a wide variety of diseases. Relying on a single product or technology makes it difficult to simultaneously achieve balance in clinical analysis of exhaled VOC molecules, patient compliance, and application scenario requirements. ChromX HealthFocusing on the Fourth-Generation Technology of Breath Analysis, based on the characteristics and needs of diseases and clinical applications, through continuous technological innovation and product development, enriching and upgrading the company's product pipeline, clinical application pipeline, and product user-friendliness,Build an Intelligent Diagnostic Platform for Exhaled VOC Analysis.

During the discussion, Dr. Wang further shared insights on the global landscape of the breath testing market, technological pathways, and strategic approaches to project deployment.

Breath testing offers a non-invasive, convenient, and precise new approach to medical diagnostics, aligning with the trend toward more accurate, accessible, and non-invasive medical testing. It has become an “invisible” hotspot in the precision medicine industry, with a rapidly growing number of companies entering the field and making significant strategic moves.

The COVID-19 breath test product recently approved by the FDA is from InspectIR. InspectIR utilizes gas chromatography–quadrupole mass spectrometry (GC-MS) for breath-based detection of opioids and illicit drugs. Following the outbreak of the COVID-19 pandemic, the company began developing breath tests for COVID-19 via volatile organic compound (VOC) analysis.

InspectIR’s COVID-19 breath test utilizes gas chromatography to separate complex volatile organic compound (VOC) components in exhaled breath, and employs quadrupole mass spectrometry to detect and identify the separated VOCs. This technology enables rapid detection of five VOCs associated with SARS-CoV-2 infection in breath samples. According to an FDA press release, a study involving 2,409 participants demonstrated that InspectIR’s COVID-19 breath test achieved a sensitivity of 91.2% and a specificity of 99.3%.

FDA’s Emergency Authorization of a Breath VOC-Based COVID-19 Diagnostic Validates the Immense Potential of Breath Testing.Exhaled VOC testing has emerged as a high-growth sector worldwide. Beyond COVID-19 detection, numerous companies are heavily investing in the fields of oncology, infectious diseases, and respiratory disorders.

Owlstone Medical, a UK-based leader in breath testing, focuses on high-difficulty areas such as gastrointestinal disorders, liver diseases, respiratory conditions, and pan-cancer early screening, taking on the most challenging tasks first. Currently, the lack of standardized sampling techniques is a major factor contributing to the identification of different biomarkers for the same disease across literature. The company’s flagship ReCIVA Breath Sampler holds promise for resolving the challenge of standardizing breath sample collection.

Crunchbase shows that Owlstone Medical has completed seven rounds of funding, raising a total of $132.9 million, with Li Ka-shing’s private equity investment firm Horizons Ventures being one of its major investors.

Menssana Research Inc. in the United States monitors cardiac immune rejection through exhaled VOC analysis. Constrained by the clinical friendliness of its products and the market size for cardiac immune rejection, the company has remained a “small but beautiful” enterprise. According to the company’s official website, it is actively developing and advancing a portable gas chromatography-based GC-SAW breath analyzer.

Israel’s NanoScent is leveraging nano-array electronic nose sensors and artificial intelligence for odor recognition, developing point-of-care testing (POCT) products for disease diagnosis via breath analysis. Singapore-based Breathonix has received provisional authorization from the Health Sciences Authority of Singapore for its COVID-19 breath test product.

In China, ChromX Health has leveraged its POCT breath-testing devices to conduct clinical follow-ups in specialized scenarios, including microbial infections (such as COVID-19 testing), respiratory diseases like asthma, lung cancer, and ICU-related conditions. The company has completed three rounds of financing, with investors including the Beijing-Tianjin-Hebei National Technology Innovation Center, the Greater Bay Area Collaborative Innovation Research Institute, ZhenFund, and Country Garden Ventures.

The global market for exhaled breath VOC testing is rapidly gaining momentum. From a technological perspective, the gap between China and overseas markets is minimal. However, from a regulatory standpoint, international markets are actively embracing this emerging technology; the United States has already approved multiple exhaled breath VOC testing products, whereas few such products have been approved in China. Overall, no international oligarchs have yet emerged in the field of exhaled breath VOC analysis and diagnostics.Domestic and international breath testing companies are on the same starting line.

It is foreseeable that breath testing will usher in a new wave of precision medicine, with related enterprises and products both domestically and internationally emerging in rapid succession. Currently, industry players have adopted varying strategies in their pipelines and technological approaches; future competition will focus on two key directions,First, clarify the strategic layout of breath testing items from a wide range of detectable parameters across broad application fields to accelerate implementation; second, drive the iteration of breath testing technologies, enabling breath VOC detection to expand from specialized laboratories to more diverse scenarios such as hospital bedside, community settings, and homes.

A major feature of breath testing is its ability to detect a wide range of analytes, covering multiple application scenarios. Currently, breath testing companies both in China and abroad have developed portfolios with distinct characteristics, ranging from high-demand tests such as those for SARS-CoV-2 to highly challenging products like pan-cancer early screening.

When discussing the strategic layout of breath testing initiatives, Dr. Wang Junqi stated: “Accelerating the clinical implementation of breath testing should be one of the core objectives for project layout in the field of breath VOC diagnostics at the current stage.”

Guided by the goal of “accelerating the clinical implementation of breath tests,” ChromX Health proposed“SPAM, the Luncheon Meat Analysis Method”S stands for Standard, which involves a thorough understanding of the current gold standards and commonly used diagnostic techniques for disease diagnosis; P refers to Pain Point, aiming to identify the clinical pain points associated with existing standard technologies; A denotes Application, focusing on identifying unique applications of breath testing that complement existing standards and address these pain points; M represents Market, entailing an assessment of the market size corresponding to the project to ultimately formulate a rational project layout.

Based on the “SPAM, Luncheon Meat Analysis” framework, ChromX Health has currently laid out its strategic presence, includingMicrobial infections (including COVID-19 testing), respiratory diseases such as asthma, lung cancer, and ICU-related conditionsand other major niche markets.

Dr. Wang Junqi stated, “Respiratory infectious diseases represent a key application area for breath testing. Leveraging the opportunity presented by COVID-19 breath tests, we aim to accumulate more experience in managing large-scale outbreak emergencies and develop infectious disease diagnostic products that offer higher patient compliance, greater timeliness, enhanced safety, and better cost-effectiveness.”

Furthermore, a 2019 article in The Lancet pointed out that the number of adult asthma patients in China is close to 50 million, and the sensitivity and specificity of traditional FeNO technology need to be improved. ChromX Health has closely collaborated with hospitals on clinical follow-ups for adult asthma. Studies have shown thatExhaled VOC testing for adult asthma demonstrated a specificity of 94.6%, a sensitivity of 94.1%, and an overall accuracy of 94.4%.higher than the clinically commonly used FeNO testing, andCan determine asthma subtypes,Provide medication guidance to physicians.

Acute respiratory distress syndrome (ARDS) is one of the common complications in critically ill patients, with a mortality rate as high as 30%-60%. Clinical chest X-rays are a commonly used diagnostic technique but heavily rely on physicians' clinical experience. Clinical studies by ChromX Health have shown that exhaled VOC detection technologyThe positive predictive value for acute respiratory distress syndrome was 94%, with an accuracy of 87%.and can be adjusted based on changes in breath analysisPredicting Disease 24–48 Hours in Advance, providing clinicians with earlier warnings to assist them in preparing relevant intervention plans in advance.

In the field of lung cancer, both incidence and mortality rates rank first among all types of cancer in China, with significant pain points existing in early diagnosis and treatment. Studies have shown that, in a sample size of hundreds of cases, ChromX Health's breath analysis technology canUsed for early diagnosis, medication guidance, and prognosis monitoring of lung cancer, it demonstrates exceptionally high overall specificity and sensitivity, outperforming blood tumor markers commonly used in clinical practice.It also enables the identification of lung cancer subtypes, facilitating targeted therapy for different types of lung cancer and addressing the limitations of imaging techniques, which cannot perform subtype classification, and blood biomarkers, which exhibit poor specificity.

Notably, projects by breath-testing companies are all at the stage of single-point deployment. Each company typically leverages a single technology to address several diseases, and their key equipment technologies rely on scientific instrument manufacturers such as Thermo Fisher Scientific, Agilent Technologies, and Hexin Instruments. This dependence makes it difficult to establish systematic, platform-based layouts.

ChromX Health is one of the few companies that balances the development of a clinical pipeline for breath testing with the capability to continuously upgrade its technology. The companyA compact POCT breath-testing device developed using MEMS technology enables rapid collection and analysis of patient samples at the bedside,It is expected to be applied in health examination centers and communities, while throughArtificial intelligence algorithms for automated interpretation of breathprints,It overcomes the drawbacks of traditional large-scale testing equipment, such as cumbersome operation, lengthy detection and data analysis times, and inapplicability at the bedside or in community settings. By liberating breath testing from spatial constraints, it enables broader application scenarios and facilitates platform-based development.

Leveraging the advantages of breath-based diagnostics, including simplicity, non-invasiveness, and abundant sample availability,It will be a major trend in the future for exhaled VOC testing to expand from clinical laboratories to intensive care units (ICUs), community medical centers, and health management centers, and even into home environments, bringing it closer to the general public.

Particularly, with the approval of multiple Chinese COVID-19 antigen test products for home use, the policy regulatory and market education challenges facing medical testing products in home settings have been partially overcome. This has also heightened expectations for the application of breath testing in home environments.

However, constrained by technological limitations, traditional equipment is bulky and complex, restricting its use to clinical laboratories.Technological iteration toward point-of-care testing (POCT), specifically the development of miniaturized, portable breath analysis devices suitable for home use, has consistently been the direction for next-generation product upgrades among companies both in China and abroad.

Most breath tests currently in use employ third-generation technology, exemplified by Owlstone Medical. This approach typically utilizes breath sample collectors, such as thermal adsorption–desorption tubes or sampling bags, followed by analysis of the breath samples using conventional “thermal desorption coupled with gas chromatography–mass spectrometry” or “conventional mass spectrometry.”

“Sample analysis technology has been effectively addressed by breath analysis instrument companies both domestically and internationally.”Standardization of sampling technology is an issue that third-generation technology companies need to address before large-scale clinical adoption.“For instance, addressing the widespread issue of surface physical adsorption in sampling bags, as well as the impact of ambient temperature variations between winter and summer on sample adsorption within the bags during sampling and transport; whereas for thermal adsorption-desorption tubes, efforts are more focused on promoting standardization in aspects such as adsorbent materials, sampling protocols, and sampling volumes,” stated Dr. Wang Junqi.

With the rapid development of MEMS, micro gas-phase analysis technology has become quite mature. Meanwhile, the rapid advancement of artificial intelligence and big data technologies in recent years has provided intelligent and efficient tools for establishing clinical diagnostic models and rapidly interpreting data. CurrentlyExhaled VOC Detection Is in a Critical Transition Period from Third-Generation to Fourth-Generation Technology. 

The fourth-generation technology is characterized by the point-of-care testing (POCT) of exhaled volatile organic compound (VOC) analysis,Clinical data analysis has evolved from the traditional approach of relying on gas chromatography for separation, followed by stepwise analysis and identification of individual molecules using techniques such as mass spectrometry, toRapid holistic analysis and assessment of exhaled VOC profiles and VOC biomarker combinations based on clinical big data and artificial intelligence.

“ChromX Health has deployed bedside mobile breath analyzers, portable breath analyzers, and home-use breath analyzers for scenarios including hospitals, communities, elderly care centers, and home settings. The first bedside breath analyzer has been fully developed and is set to launch soon,” revealed Dr. Wang Junqi.

“Regulatory agencies and investors are rapidly increasing their acceptance of breath testing, and more companies will enter the field of breath VOC detection in the future,”Clinical pipeline layout and proprietary core technologies will be the key competitive factors among enterprises.“Moving forward, ChromX Health will continue to drive technological innovation, developing products tailored for hospitals, health examination centers, community healthcare facilities, and home use. By collaborating closely with hospital experts, we aim to accelerate the clinical adoption of exhaled breath VOC testing.”