Publications
Improving the future of early cancer detection through rigorous science.
Evaluation of a Novel Blood-Based Lung Cancer Screening Test in Elevated-Risk Subjects
LUNG CANCER
ASCO 2026
This poster presents data evaluating Mercy BioAnalytics’ EVP-based blood test for lung cancer screening in elevated-risk individuals from the National Lung Screening Trial. The study found that the EVP-based blood test showed similar sensitivity and specificity to LDCT across two screening encounters and detected a subset of cases one year prior to in-trial diagnosis, supporting its potential as a minimally invasive approach for early lung cancer detection.
Evaluation of a Novel Blood-Based Lung Nodule Triage Test in Elevated-Risk Subjects
LUNG CANCER
ASCO 2026
This poster presents data evaluating Mercy BioAnalytics’ EVP-based Lung Nodule Triage Test in elevated-risk individuals with Lung-RADS findings from the National Lung Screening Trial. Results showed early evidence of clinically meaningful performance for detecting lung cancer among subjects with Lung-RADS 3 and 4A scores, supporting the potential use of an EVP-based blood test to help improve risk stratification following LDCT screening.
Detection of early-stage lung adenocarcinoma using a novel extracellular vesicle and particle-based blood test
LUNG CANCER
Scientific Reports
Tumor-derived extracellular vesicles and particles (EVPs) represent a promising analyte class for early cancer detection. However, discrimination of tumor-derived EVPs from those shed by healthy tissues represents a major analytical challenge. This work describes the design and characterization of a novel proximity ligation-based immunoassay which targets tumor-derived EVPs in plasma displaying four colocalized surface biomarkers. We demonstrate the functionality of this approach in cancer cell line-derived EVPs and apply the method to lung adenocarcinoma (LUAD) detection. Importantly, we find that requiring four colocalized cancer-associated biomarkers reduces interference from healthy EVPs versus a three-biomarker design, resulting in strong discrimination performance for several biomarker combinations. Using this approach, we developed a prototype assay for LUAD detection which was evaluated in a case-control study composed of 92 LUAD cases and 290 non-cancer controls. The assay and trained classifier exhibited 48.5% (33/68; 95% confidence interval (CI) 37.1–60.2%) stage I sensitivity, 83.3% (15/18; 95% CI 59.8–94.8%) stage II sensitivity, and 100% (6/6; 95% CI 55.2–100%) stage III/IV sensitivity at 90% specificity. Assay signal was significantly correlated with tumor size and uncorrelated with smoking history. These preliminary results demonstrate the technical feasibility of this platform for early-stage lung cancer detection.
Extracellular vesicle and particle-based blood test for ovarian cancer screening of average risk population: a promising nested case control study using preclinical samples
OVARIAN CANCER
ScienceDirect – Gynecologic Oncology
Current screening methods often miss early-stage ovarian cancer, but in a blinded case-control study using preclinical samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), Mercy’s blood test measuring tumor-associated extracellular vesicles and particles (EVPs) demonstrated 83% sensitivity and 98% specificity for detecting high-grade serous carcinoma (HGSC)—the most common and lethal form of ovarian cancer. Remarkably, in early-stage (I/II) HGSC, the EVP-based test achieved 89% sensitivity. These results highlight the promise of EVP-based testing as a potential annual screening tool for ovarian cancer in average-risk women, enabling earlier detection and improved outcomes.
Colocalization of cancer-associated biomarkers on single extracellular vesicles for early detection of cancer
OVARIAN CANCER
The Journal of Molecular Diagnostics
Tumor-derived extracellular vesicles (EVs) are among the most abundant biomarkers in the blood, offering significant advantages for detecting early-stage cancers compared to lower-abundance markers like circulating tumor DNABy measuring co-localized membrane proteins on the surface of these tumor-associated EVs, the platform enables a highly sensitive and specific determination of cancer presence or absence. The combination of a simple assay design and a qPCR readout also enables low-cost testing. This innovative combination of features allows the Mercy Halo platform to achieve the high performance and broad accessibility required for a population-wide cancer screening test.
Improving specificity for ovarian cancer screening using a novel extracellular vesicle-based blood test – Performance in a training and verification cohort
OVARIAN CANCER
The Journal of Molecular Diagnostics
A HGSC case-control training clinical sample set was used to lock down the test design, the data interpretation algorithm, and establish the cut-off between cancer and non-cancer in the Mercy Halo assay. Test performance was then verified in an independent blinded case-control study. In the verification study, the test showed 97.0% specificity, 97.0% HGSC sensitivity, and an AUC of 0.97. This included a sensitivity of 84.6% for stage I and 100% for stage II, with a specificity of 97%. Compared to CA125, this test produced fewer false positives in patients with benign ovarian tumors, non-ovarian cancers, and inflammatory conditions, suggesting it may be a promising tool for ovarian cancer screening.
Presentations
Sensitive and specific detection of early-stage lung adenocarcinoma using an extracellular vesicle and particle-based blood test
American Thoracic Society 2026 International Conference
This poster presents clinical evaluation of Mercy BioAnalytics’ extracellular vesicle and particle, or EVP-based, blood test for early lung cancer detection. The study evaluated a prototype lung cancer assay in plasma samples from both high-risk individuals eligible for lung cancer screening and average-risk individuals without a history of tobacco use. Results support the potential of EVP biomarker colocalization as a minimally invasive approach for detecting early-stage lung adenocarcinoma and warrant further evaluation in larger clinical studies.
Extracellular vesicle and particle surface biomarker colocalization as a platform for early cancer detection
International Society for Extracellular Vesicles 2026 Annual Meeting
This poster highlights Mercy’s EVP-based platform and proximity ligation immuno-PCR workflow for detecting colocalized cancer-associated biomarkers on the surface of extracellular vesicles and particles. The work demonstrates the platform’s potential application across early cancer detection, including ovarian and lung cancer.
A next-generation extracellular vesicle and particle-based liquid biopsy for early lung cancer detection
LUNG CANCER
American Association for Cancer Research 2026 Annual Meeting
This poster presents clinical evaluation of Mercy’s EVP-based liquid biopsy approach for early lung cancer detection. The study evaluated performance in both high-risk individuals eligible for screening and average-risk individuals without a history of tobacco use, supporting the potential of EVP-based testing as a minimally invasive approach to lung cancer detection.
Performance of an extracellular vesicle and particle-based ovarian cancer screening test in average-risk postmenopausal women up to 3 years prior to clinical diagnosis
Society of Gynecologic Oncology 2026 Annual Meeting on Women’s Cancer
This poster presents results from a retrospective, blinded evaluation nested within UKCTOCS, assessing the performance of Mercy’s EVP-based blood test for ovarian cancer screening in average-risk postmenopausal women. The data show strong discrimination versus CA125, including improved detection of early-stage high-grade serous ovarian cancer prior to clinical diagnosis.
Evaluating the impact of endogenous interfering substances on a novel extracellular vesicle and particles based ovarian cancer test
2025 Association for Molecular Pathology (AMP) Annual Meeting & Expo
Here we evaluated the robustness of a novel extracellular vesicle and particle (EVP) based assay designed for the early detection of ovarian cancer. Targeting five ovarian cancer biomarkers, the assay’s performance was tested against common endogenous substances known to interfere with diagnostic assays, across clinically relevant concentrations. No clinically significant interference was observed, except at supraphysiologic rheumatoid factor levels, which did not translate to differences in clinical rheumatoid arthritis samples compared with healthy controls. These results demonstrate the assay’s high specificity and low susceptibility to interference, supporting its potential for reliable early ovarian cancer detection and broader applicability to other non-invasive cancer diagnostics.
Characterization of extracellular vesicles and particles from cell lines as reference material for use in an immuno-PCR assay
OVARIAN CANCER
2025 Association for Molecular Pathology (AMP) Annual Meeting & Expo
Tumor-associated extracellular vesicles and particles (EVP) have emerged as highly valuable analytes for early-stage cancer detection. An EVP-based blood test was developed for ovarian cancer that detects the presence of tumor specific biomarkers co-localized on the surface of EVP. To maintain reproducibility and reliability across different reagent lots for the test, a novel, stable, and traceable reference material must be established. To address this, we developed reference material using EVP derived from an ovarian cancer cell line. Characterization of this novel reference material demonstrates that cell line EVP serve as a suitable surrogate for serum-derived EVP and can be used as reference materials.
Low-dose CT screening sensitivity in the National Lung Screening Trial varies with diagnostic window length
LUNG CANCER
ATS International Conference 2025
Low-dose CT (LDCT) became the standard for lung cancer screening based on the NLST, which reported a 20% mortality reduction and high sensitivity (84.9% initial, 78.6% follow-up). However, these estimates relied on a 12-month diagnostic window, potentially missing cancers diagnosed after that window. We reanalyzed NLST patient-level data to assess LDCT sensitivity over extended timeframes. Our findings suggest the original sensitivity was systematically overestimated, particularly for screen-negative cases later diagnosed with cancer.
Performance of an extracellular vesicle based ovarian cancer screening test in longitudinal preclinical samples from women with high grade serous ovarian cancer - an exploratory subgroup analysis
2025 ACOG Annual Clinical & Scientific Meeting
CA125 and imaging lack the early-stage sensitivity and specificity to be effective screening tests. The detection of multiple colocalized cancer-related biomarkers offer increased sensitivity and specificity. We evaluated the performance of the EV-based blood test in a retrospective-blinded-evaluation nested within UKCTOCS which represents the intended target population for clinical application of this test. In this study, we found that the sensitivity of the EV-based blood test was 83% (89% Stage I/II) with 97.7% specificity, while CA125 showed 68% (46% Stage I/II) sensitivity with 95.6% specificity.
Ezekiel: A simulated digital twin for virtual diagnostic biomarker screening
OVARIAN CANCER
2025 American Association for Cancer Research (AACR) Conference
The combinatorial space of biomarker triplets is massive, too large to efficiently explore experimentally. We created a custom biomarker/combination discovery pipeline called Ezekiel to nominate EV-specific markers and combinations. Using this digital screening enriches markers and combinations we experimentally validate with those that are high sensitivity.
Protocol for clinical validation of an ovarian cancer screening test using blinded retrospective evaluation of prospectively collected samples from a screening trial
OVARIAN CANCER
2025 American Association for Cancer Research (AACR) Conference
Due to the low incidence of ovarian cancer, a traditional, prospectively collected validation study for an ovarian cancer screening test would be prohibitively burdensome, taking many years and requiring an enormous number of subjects. Due to the low volume requirements of our Mercy Halo technology and the stability of extracellular vesicles, we are able to conduct an initial validation study by analyzing samples collected during the prospectively enrolled, 20-year, 200,000 person UKCTOCS trial.
Correlation of a novel extracellular vesicle-based ovarian cancer blood test with patient-matched tumor multiomics analysis of high-grade serous ovarian carcinoma
2025 Advances in Genome Biology and Technology
Screening tests for ovarian cancer that rely on a single biomarker such as CA125 and/or imaging lack early stage sensitivity. Extracellular vesicles (EVs) in the blood offer increased sensitivity due to their abundance and increased specificity through the detection of multiple, colocalized biomarkers. We evaluated a locked EV blood test using 5 key biomarkers and determined that benign tissues showed low expression of those key biomarkers and that high grade serous ovarian cancer showed high expression of the biomarker. Further, this test showed 89% sensitivity in detecting stage I and II ovarian cancer, at a specificity of 98%.
Evaluation of a novel extracellular vesicle based ovarian cancer screening test in asymptomatic postmenopausal women
2024 Early Detection of Cancer Conference
We evaluated the EV based ovarian cancer test in a blinded case-control study nested within the no screening and annual ultrasound screening (USS) arms of UKCTOCS. In healthy controls, we observed a 97.7% specificity for the OC Test, and 95.6% for CA125. We observed a sensitivity of 83% for the OC test in samples drawn 0-12 months prior to Dx, and 68% for CA125. Only 2.3% women who underwent surgery for false positive USS results were positive for the OC Test vs 10.5% for CA125. The OC Test is capable of highly sensitive and specific detection of HGSOC in asymptomatic postmenopausal women one year prior to diagnosis and can detect HGSOC up to three years prior to Dx with higher sensitivity and specificity compared to CA125.
A novel extracellular vesicle based liquid biopsy method for the early detection of cancer
OVARIAN CANCER
2024 NCI Alliance for Nanotechnology in Cancer Annual Principal Investigator Meeting
Ovarian cancer is one of the deadliest gynecological cancers, often diagnosed at advanced stages when treatment options are limited. Current screening methods are expensive and lack the necessary sensitivity, underscoring the need for a more cost-effective and accurate test. Utilizing an EV-based OC test, we retrospectively analyzed samples from asymptomatic postmenopausal women in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). The OC Test demonstrated 84% sensitivity and 98% specificity, enabling highly sensitive detection of high-grade serous ovarian cancer, even in the earliest stages, while maintaining excellent specificity. These results highlight the potential of the OC Test for ovarian cancer screening.
Analytical and clinical performance of a novel ovarian cancer screening test in asymptomatic women
2024 Association for Diagnostics and Laboratory Medicine (ADLM) Conference
Ovarian cancer ranks among the deadliest gynecological cancers, often diagnosed at advanced stages when treatment options are limited. Current methods are costly and lack sensitivity, highlighting the need for a cost-effective test with improved performance. Using an EV based OC test, we retrospectively assessed samples from asymptomatic postmenopausal women from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). With an 84% sensitivity and 98% specificity, the OC Test is capable of highly sensitive detection of high-grade serous ovarian cancer, including at the earliest stages of disease progression, while maintaining high specificity. The data demonstrates the potential application of the OC Test for ovarian cancer screening.
Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women
OVARIAN CANCER
2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Screening for OC that relies on CA125 and imaging lacks early-stage sensitivity, highlighting the need for a more effective test. EVs in blood may provide increased sensitivity from vesicles released in abundance and increased specificity from assessing multiple cancer-related markers colocalized on a vesicle surface. By studying the performance of an EV based OC Test in samples from asymptomatic postmenopausal women in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), we have demonstrated that it is capable of highly sensitive and specific detection of HGSC in asymptomatic postmenopausal women one year prior to Dx and can detect HGSC up to three years prior to Dx with superior sensitivity and specificity compared to CA125.
Colocalization of ovarian cancer-associated biomarkers in tumors, cancer cells and extracellular vesicles
OVARIAN CANCER
2024 American Association for Cancer Research (AACR) Annual Meeting
We have previously shown that ovarian cancer can be detected by interrogating colocalized, membrane-associated cell-surface biomarkers on single extracellular vesicles (EVs). Our blood-based Ovarian Cancer Test (OC Test) detects cancer-associated EVs from human plasma to distinguish high-grade serous ovarian carcinoma (HGSC) from both benign ovarian tumors and normal samples. Using nanoimaging of human cell line EVs and mIHC staining of ovarian benign and tumor tissue, we show that the ovarian cancer biomarkers detected by our assay demonstrate colocalization on the surface EVs and on cancer cells within ovarian tumor biopsies, and that expression and colocalization of the biomarkers correlates with assay signal from patient plasma samples. The results demonstrate that the OC Test biomarkers are both enriched and colocalized on tumor tissue and EVs from ovarian cancer cell lines. These results provide further evidence that colocalized biomarkers on EVs can be utilized for the early detection of HGSC.
Development and characterization of a liquid biopsy assay for the detection of colocalized biomarkers on extracellular particles
OVARIAN CANCER
2023 International Society for Extracellular Vesicles
Detection of early-stage cancer, when it is most treatable, remains a significant challenge. Extracellular particles (EPs) derived from cancer cells offer a unique analyte for diagnostic tests given their abundance, stability, and representation of the cell of origin. Here, we describe the development of Mercy Halo™, an immunoassay designed to capture and detect up to three distinct, colocalized biomarkers on tumor-derived EPs in human blood samples. In proof-of-concept testing, we demonstrate the sensitive and specific detection of stage I and II high-grade serous ovarian cancer (HGSOC) in human plasma, outperforming CA125 in the discrimination of benign and malignant ovarian masses.
Colocalization of cancer-associated biomarkers on single extracellular vesicles for early-cancer detection
OVARIAN CANCER
2023 American Association of Cancer Research (AACR) Annual Meeting
Tumor-derived extracellular vesicles (TDEVs) are an ideal analyte for liquid biopsy diagnostic assays. We describe a platform technology, Mercy Halo™, which interrogates millions of individual EVs within a plasma or serum sample to capture and detect TDEVs. We demonstrate that biomarkers present on cancer cells are colocalized on EVs derived from a tumor and are readily detectable using the Mercy Halo platform. Using panels of antibodies targeting up to three cancer-associated biomarkers simultaneously, we demonstrate Mercy Halo enables sensitive and specific detection of early-stage high-grade serous ovarian carcinoma (HGSOC) with excellent reproducibility in a proof-of-concept (PoC) study.
Development and preliminary validation of a test for early-stage cancer detection measuring colocalized biomarkers on single extracellular vesicles
OVARIAN CANCER AND LUNG CANCER
2022 Early Detection of Cancer Conference
Colocalization of cancer-associated biomarkers on intact, single extracellular vesicles (EVs) is a novel approach that can dramatically boost early-stage sensitivity of a liquid biopsy test. To leverage this principle, we developed Mercy Halo™—a platform technology that detects tumor-derived EVs in blood displaying multiple colocalized cancer-associated biomarkers. We
assessed the clinical feasibility of this approach by applying the technology to early-stage ovarian cancer (OC) and lung cancer (LC) detection.
Extracellular vesicle-based biomarker assay for the detection of early-stage ovarian cancer
OVARIAN CANCER
2022 American Society of Clinical Oncology (ASCO) Annual Meeting
Detection of cancer with improved discrimination compared to current blood tests could be achieved using an approach that assesses extracellular vesicles (EVs). This approach should have high sensitivity (se) because of EVs abundance in blood and high specificity (sp) by assaying EVs with multiple cancer-related protein and glycosylation epitopes (PGEs) co-localized on their surfaces. We are developing a platform technology that detects multiple cancer-related PGEs co-localized on the same EV using immunoaffinity-capture and proximity-ligation qPCR. In this study, we compare the performance of this technology vs plasma CA125 for correctly categorizing early-stage high-grade serous ovarian cancer (HGSOC) vs healthy/benign ovarian tumors (OT).
Preliminary results for a novel single extracellular vesicle assay for early-stage ovarian cancer: The power of co-localized detection of surface biomarkers
OVARIAN CANCER
2022 American Association for Cancer Research (AACR) Annual Meeting
These preliminary data suggest that co-localization of surface biomarkers in single EVs may provide an effective means to identify women with early-stage high-grade serous ovarian cancer (HGSOC), including those with normal CA125, while avoiding false positives in women with benign masses and high CA125. Despite the inherent challenges associated with commercial samples, our finding that several combinations detected early-stage HGSOC is promising. Statistically powered studies with curated repository specimens are underway to refine combinations and independently validate our assay for early-stage ovarian cancer detection.
Preliminary results for a novel single extracellular vesicle assay for early lung cancer: The power of co-localized detection of surface biomarkers
LUNG CANCER
2022 American Association for Cancer Research (AACR) Annual Meeting
These preliminary data highlight the potential of detecting biomarkers co-localized on the surface of single EVs as an effective tool for early-stage lung cancer detection, and the benefit of using 3 biomarkers simultaneously. Despite inherent challenges associated with commercial samples, our finding that detection of co-localized EV surface biomarkers distinguished lung adenocarcinoma (LUAD) is promising. Additional studies with lung cancer cohorts beyond LUAD are underway to refine combinations and independently validate our assay for early-stage lung cancer detection.