Pipeline
What Drives Us Forward
Access to early-stage diagnostic information is a pain point for patients and providers, resulting in over 4.5B unfulfilled lab tests and over $100B in avoidable healthcare costs in the US annually. We believe TRACE-E will address current diagnostic limitations by offering a non-invasive, scalable option for a variety of point-of-care settings that prioritizes patient comfort and reliable results.
We are building a comprehensive platform focused on improving patient outcomes across cardiometabolic (CMD), neurodegenerative, oncology and infectious disease categories.
The Journey Begins with Chronic Kidney Disease
Our initial clinical program focuses on validating early-stage breath biomarkers for CKD which will catalyze TRACE-E commercialization and address the urgent need for improved monitoring in at-risk CMD populations. Currently, late-stage diagnoses are common and often lead to a lifetime of co-morbidities and complications. To learn more visit our Kidney Disease page.
We expect to pursue FDA market authorization in 2027, with market entry slated for 2028.
On the Horizon
Our Discovery Process
We’ve developed a proprietary discovery process that reflects the flexibility of our sensor technology and the speed with which TRACE-E can be optimized for biomarker candidates and different diseases.
Pipeline Programs
Trace Sensing is actively engaged in several breath biomarker discovery and validation studies using TRACE-E across a range of disease states.
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The Unmet Need
Nearly 7 million people are diagnosed with ADRD and cases are projected to nearly double by 2050¹. ADRD is the seventh leading cause of death in the United States and the top cause of disability and poor health in older adults¹, often requiring specialized and costly care. 2024 direct costs of ADRD care in the US were an estimated $360B, with $231B being paid by Medicare and Medicaid.¹
Limitations of Current Diagnostics
Currently no technologies offer non-invasive clinical diagnosis and monitoring of preclinical ADRD. Identification and measurement of blood biomarkers or subtle brain changes rely on tools that are complex, invasive, expensive, and subject to difficult operating conditions. A scalable, accurate, and non-invasive ADRD diagnostic method is needed to address the growing public health crisis.
TRACE-E for ADRD
Trace Sensing is evaluating TRACE-E for preclinical Alzheimer’s Disease detection. Our study design compares and validates TRACE-E against gold-standard diagnostic tools for ADRD to confirm breath biomarkers with qualitative and quantitative links to amyloid deposition.
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The Unmet Need
Esophageal Cancer (EC) accounts for 15% of all cancer-related mortality worldwide (~1.5 million).¹ ² Like many cancers, esophageal cancer is most treatable when caught early. Treatment of early-stage EC is associated with long-term survival rates of 83-96%,¹ however, due to late diagnosis, overall survival of EC ranges from 20-50%.
Limitations of Current Diagnostics
Without an effective biomarker for detection of early-stage EC, screening is not universally performed. A highly invasive endoscopy with biopsy is the current diagnostic standard for EC. The procedure presents a risk of bleeding and perforation, and it is perceived as uncomfortable by patients.
TRACE-E for Esophageal Cancer
Since 2024, Trace Sensing has been evaluating TRACE-E’s ability to identify breath biomarkers for esophageal cancer and cancer precursors.
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The Unmet Need
In 2023 there were an estimated 263 million malaria cases and nearly 600,000 deaths across 83 countries. The sub-Saharan Africa region bears a disproportionately high share of this burden, with children under five accounting for about 76% of all malaria deaths in the region.¹ Despite decades of investment and progress, there remains an urgent need for improved diagnostic tools to further reduce the global impact of this disease. According to the World Bank, Malaria Consortium, and other global health studies, tackling malaria is not only a health imperative but also an economic necessity.²
Limitations of Current Diagnostics
Current rapid diagnostic tests (RDT’s) often fail to detect low parasite densities common in asymptomatic or early infections, limiting their usefulness in elimination settings. They primarily target the histidine rich protein HRP2/3 antigen of P. falciparum, but in some regions, parasites carry HRP 2/3 gene deletions, rendering HRP 2/3 based RDTs ineffective due to false negative results. A further issue is antigen persistence. HRP 2/3 may remain detectable for weeks after parasite clearance, leading to false positives.
The Opportunity: Transforming Malaria Diagnostics
There is an urgent and unmet need for improved diagnostic tools that are not only faster, more affordable, and highly sensitive, but also capable of achieving the necessary specificity to guide appropriate treatment decisions. Critically, these tools must be designed for deployment in low-resource settings, where the burden of malaria remains highest. Bridging this diagnostic gap is essential not only for improving individual patient outcomes through timely and accurate care, but also for strengthening public health efforts, and ultimately to expedite global progress toward malaria elimination.
TRACE-E for Malaria
Trace Sensing is developing a preliminary pilot study to assess TRACE-E’s utility as a Malaria diagnostic and monitoring tool in 2026.
1 https://www.who.int/news-room/fact-sheets/detail/malaria?utm
2 https://www.worldbank.org/en/topic/health/brief/malaria?utm
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The Unmet Need
Tuberculosis (TB) remains the world’s leading infectious disease killer. In 2023, the World Health Organization (WHO) reported 8.2 million new TB cases, the highest since monitoring began in 1995, and up from 7.5 million in 2022.¹ Despite decades of investment, TB continues to increase, highlighting the urgent need for improved tools to reduce the global burden of disease.
Limitations of Current Diagnostics
Existing TB diagnostics struggle to address this persistent global health issue. Smear microscopy may fail to detect cases with low bacterial loads, particularly in early infection. Chest X-rays lack specificity that could lead to misdiagnosis. While molecular assays are more accurate, their cost, infrastructure needs, and technical requirements may restrict widespread use in low- and middle-income countries where TB is most prevalent. These deficiencies may result in missed or delayed diagnoses, contributing to ongoing household and community transmission.
The Opportunity: Transforming TB Diagnosis
There is a clear, urgent need for a diagnostic tool that is faster, affordable, sensitive, and specific, particularly one that can be deployed in low-resource settings. Addressing this gap is essential not only to improve patient care but also to interrupt transmission and accelerate progress toward TB elimination.
TRACE-E for Tuberculosis
Trace Sensing is developing a preliminary pilot study to evaluate TRACE-E as a rapid TB diagnostic tool in 2026.
1 https://www.who.int/news/item/29-10-2024-tuberculosis-resurges-as-top-infectious-disease-killer?utm
To learn more about TRACE-E’s capabilities or to explore a research partnership,
please reach out.
