Test For Early Detection Research Articles

A CLIA/CAP Compliant Noninvasive Laboratory Developed Test for Early Detection of Pancreatic Ductal Adenocarcinoma

A CLIA/CAP Compliant Noninvasive Laboratory Developed Test for Early Detection of Pancreatic Ductal Adenocarcinoma

Is There a Correlation Between Platelet Count, Mesenteric Lymph Node Involvement, and Hematogenous Metastases in Advanced Stage Ovarian Cancer?

Ovarian cancer remains a major cause of death in women worldwide, mainly due to late diagnosis and the lack of a reliable screening test for early detection of the disease. In this context, attention has been focused on the identification of other prognostic factors that might allow a better identification of cases with worse long-term outcome. Data of patients who underwent cytoreductive surgery between 2014-2019 were retrospectively reviewed and 57 patients were considered eligible for this study. These cases were further classified according to preoperative platelet count, with a cut-off value of 335,000/μl as a positive predictive value for long-term survival. According to this value, there were 27 cases with a preoperative platelet count lower than 335,000/μl and 30 cases with a preoperative platelet count higher than 335,000/μl. Cases in the second group had a significantly higher peritoneal carcinomatosis index (p=0.002), a higher proportion of digestive serosa involvement (p<0.001), and a higher proportion of mesenteric lymph node involvement and hematogenous metastases (p=0.005 and p=0.001, respectively). When analyzing long-term outcomes, all these factors had a significant impact on overall survival. Preoperative thrombocytosis appears to be positively associated with gastrointestinal serosa involvement, mesenteric lymph node invasion, and the presence of hematogenous metastases, thus significantly influencing the long-term outcome of patients with advanced ovarian cancer.

Integrating Multi-Cancer Early Detection (MCED) Tests with Standard Cancer Screening: System Dynamics Model Development and Feasibility Testing.

Cancer screening plays a critical role in early disease detection and improving outcomes. In Australia, established screening protocols for colorectal, breast and cervical cancer have significantly contributed to timely cancer detection. However, the recent introduction of multi-cancer early detection (MCED) tests arguably can disrupt current screening, yet the extent to which these tests provide additional benefits remains uncertain. We present the development and initial validation of a system dynamics (SD) model that estimates the additional cancer detections and costs associated with MCED tests. This article describes the development of a simulation model built to evaluate the additional patient diagnoses and the economic impact of incorporating MCED testing alongside Australia's well-established standard of care (SOC) screening programs for colorectal, breast, cervical and lung cancers. The model was designed to estimate the additional number of patients diagnosed at each cancer stage (stage I, II, III, IV, or unknown) and the associated costs. This simulation model allows for the analysis of multiple scenarios under a plausible set of assumptions regarding population-level participation rates. An SD model was developed to represent the existing SOC national cancer screening pathways and to integrate potential clinical pathways that could be introduced by MCED tests. The SD model was built to investigate three scenarios for the use of MCED testing: firstly, to explore the viability of MCED testing as a substitute among individuals who are not opting for SOC screening for any reason; secondly, to implement MCED testing exclusively for individuals ineligible for SOC screening, yet have high-risk characteristics; and thirdly, to employ MCED testing after SOC screening to serve as a triaging/confirmatory tool for individuals receiving inconclusive test results. The three primary scenarios were constructed by varying diagnostic accuracy and uptake rates of MCED tests. The clinical utility and outcomes of MCED testing for screening and early detection still lack comprehensive evidence. Nonetheless, this simulation model facilitates a thorough analysis of MCED tests within the Australian healthcare context, providing insights into potential additional detections and costs to the healthcare system, which may help prioritise future evidence development. The adaptable yet novel SD model presented herein is anticipated to be of considerable interest to industry, policymakers, consumers and clinicians involved in informing clinical and economic decisions regarding integrating MCED tests as cancer screening and early detection tools. The expected results of applying this SD model will determine whether using MCED testing in conjunction with SOC screening offers any potential benefits, possibly guiding policy decisions and clinical practices towards the adoption of MCED tests.

Machine Learning Approaches in Multi-Cancer Early Detection

Cancer is a prominent global cause of mortality, primarily due to delayed detection leading to limited treatment options. Current screening methods are mostly invasive and involve complex lengthy processes with high costs. Moreover, each screening typically focuses on a single type of cancer. This imposes a growing need for innovative, precise, and minimally invasive methods for early cancer detection. With the current advances in assay technologies and data science, multi-cancer early detection (MCED) tests are gaining increased interest in the research community as they offer potential for earlier diagnosis and improved patient outcomes. Different approaches are followed for MCED, and multiple machine learning methods are considered. In this paper, we systematically explore various MCED studies and their applied machine learning (ML) models for different types of biomarker data. We discuss the strengths and limitations of different study designs and compare their performance. Future directions are proposed, emphasizing the importance of integrating multi-omics data, enhancing model transparency, and fostering collaborative efforts to develop robust, cost effective and clinically applicable MCED tools.

Circulating tumour DNA and risk of recurrence in patients with asymptomatic versus symptomatic colorectal cancer.

Multiple initiatives aim to develop circulating tumour DNA (ctDNA) tests for early cancer detection in asymptomatic individuals. The few studies describing ctDNA-testing in both asymptomatic and symptomatic patients report lower ctDNA detection in the asymptomatic patients. Here, we explore if asymptomatic patients differ from symptomatic patients e.g. by including a 'low-ctDNA-shedding' and 'less-aggressive' subgroup. ctDNA assessment was performed in two independent cohorts of consecutively recruited patients with asymptomatic colorectal cancer (CRC) (Cohort#1: n = 215, Cohort#2: n = 368) and symptomatic CRC (Cohort#1: n = 117, Cohort#2: n = 722). After adjusting for tumour stage and size, the odds of ctDNA detection was significantly lower in asymptomatic patients compared to symptomatic patients (Cohort#1: OR: 0.4, 95%CI: 0.2-0.8, Cohort#2: OR: 0.7, 95%CI: 0.5-0.9). Further, the recurrence risk was lower in asymptomatic patients (Cohort#1: sHR: 0.6, 95%CI: 0.3-1.2, Cohort#2: sHR: 0.6, 95%CI: 0.4-1.0). Notably, ctDNA-negative asymptomatic patients had the lowest recurrence risk compared to the symptomatic patients (Cohort#1: sHR: 0.2, 95%CI: 0.1-0.6, Cohort#2: sHR: 0.3, 95%CI: 0.2-0.6). Our study suggests that asymptomatic patients are enriched for a 'low-ctDNA-shedding-low-recurrence-risk' subgroup. Such insights are needed to guide ctDNA-based early-detection initiatives and should prompt discussions about de-escalation of therapy and follow-up for ctDNA-negative asymptomatic CRC patients.

A-346 Evaluating 14-3-3η Detection in Finger Prick Blood Using Lateral Flow Technology: Advancing Clinical Laboratory Diagnostics

Abstract Background The protein 14-3-3η is a critical biomarker in the diagnosis and monitoring of autoimmune rheumatologic disorders, and its early detection is pivotal for patient outcomes. Previous research has established the significance of 14-3-3η as a biomarker, particularly in inflammatory polyarthritis, as well as patients’ and physicians’ interest in near-patient testing. While 14-3-3η is traditionally measured in serum via ELISA, this study explores the innovative use of lateral flow technology (LFT) for its detection in finger prick blood, addressing the urgent need for near-patient testing.This research aims to evaluate the technical and clinical performance of 14-3-3η measurement using LFT in comparison to standard ELISA methods, with an emphasis on its detectability in finger prick blood. Methods This study included two phases of testing involving patient serum and spiked whole blood. In the serum phase, 53 samples (19 NEG, ≤0.19 ng/mL, and 34 POS, 0.27 to 28 ng/mL 14-3-3η) were tested using LFT. LFT results were compared to JOINTstat® ELISA measurements for concordance. For whole blood, recombinant 14-3-3η and ELISA-positive serum samples were spiked into whole blood at increasing concentrations (0.4 to 3.2 ng/mL) and tested with LFT. Concordance criteria included visual inspection of test and control lines, with results captured and analyzed using a reference key card. The study was extended to assess 14-3-3η levels in consented patients with 22 matched finger prick and venous serum samples​​. Results In serum testing, LFT demonstrated 100% positivity in detecting 14-3-3η for POS samples. Among NEG samples, 85% tested negative, with 15% positive, indicating a strong concordance between LFT and ELISA. The LFT's ability to semi-quantitatively measure 14-3-3η was confirmed by a significant Kruskal-Wallis test (p&amp;lt;0.0001) across four intensity groups. In whole blood testing, LFT correctly identified all samples spiked at concentrations ≥0.5 ng/mL. The Spearman correlation showed a strong and significant association (r=0.96 to 0.98, p=0.001) between LFT test line intensity and spiked 14-3-3η levels. Finally, the equivalence testing for finger prick and venous serum samples affirmed the LFT’s reliability, with a strong correlation (p&amp;lt;0.0001), underscoring its potential for near-patient testing​​. Conclusions The study validates LFT as a reliable and semi-quantitative method for detecting 14-3-3η in finger prick blood, demonstrating strong concordance with traditional ELISA measurements. The findings support the feasibility of LFT in near-patient testing for early detection, prognosis, and monitoring of autoimmune diseases, paving the way for enhanced patient accessibility. Future research will focus on integrating this technology into routine clinical care and examining its impact on patient management and outcomes.

B-240 Multi-omic blood test for early detection of cancer and pre-cancer

Abstract Background The earlier diagnosis of cancer is vital to improve patient survival. Many liquid biopsy technologies are focused on single tumor-derived biomarkers, which limits test sensitivity, especially for early-stage cancers that do not shed sufficient genetic material into the bloodstream. The Dxcover liquid biopsy employs Multi-Omic Spectral Analysis (MOSA) that interrogates a blood sample with Infrared (IR) radiation and produces a distinctive signature that represents the whole biomolecular profile of the sample. This multi-omic blood test analyzes the full complement of tumor and immune-derived markers present within blood derivatives and could facilitate the earlier detection of cancer. The technology can be tuned for high sensitivity (rule out) or high specificity (rule in) depending on the desired application, clinical priorities and international healthcare markets. Methods Three clinical studies have been completed, assessing the technology for the detection of: (1) brain cancer, (2) multiple cancers, and (3) colorectal cancer (CRC) and pre-cancerous lesions. In the first study, we recruited 988 patients prospectively with non-specific symptoms associated with a brain tumor. Secondly, we carried out a large-scale multi-cancer evaluation (n = 2092 patients), targeting eight different cancers. Moreover, the CREATE (ColoREctal cancer &amp; Adenoma Test Evaluation) feasibility study (3) examined 100 CRC, 92 adenoma samples and 104 colonoscopy screening control patients. Results In study 1, the brain cancer algorithm detected 96% of the patients with brain cancer, and 100% of glioblastomas, the most aggressive primary brain tumor. In the multi-cancer study (2), area under the receiver operating characteristic curve values were calculated for the eight cancer types versus symptomatic non-cancer controls: brain (0.90), breast (0.76), colorectal (0.91), kidney (0.91), lung (0.91), ovarian (0.86), pancreatic (0.84) and prostate (0.86). We also assessed the test performance when all eight cancer types were pooled to classify ‘any cancer’ against non-cancer patients. The cancer versus asymptomatic non-cancer classification detected 64% of stage I cancers when specificity was 99% (overall sensitivity 57%). When tuned for higher sensitivity, this model identified 99% of Stage I cancers (with specificity 59%). In the CREATE study, the test reported promising results for pre-cancer detection; at 90% specificity, the test reported sensitivities of 80% for CRC and 59% for advanced adenomas. Conclusions A rapid liquid biopsy that is sensitive to pre-cancerous lesions and early-stage cancer could substantially improve patient outcomes. There is a low barrier to integrating this blood test into existing diagnostic pathways as the technology is rapid, simple to use, and sample preparation is minimal. In addition, the spectroscopic liquid biopsy has the potential to be combined with other orthogonal tests, such as cell-free DNA, which could provide an efficient route to diagnosis. Cancer treatment can be more effective when given earlier, and this low-cost strategy has the potential to improve patient prognosis.

Multicancer Early Detection Tests: A State-of-the-Art Review for Otolaryngologists.

To provide a review of the science and applicability of current multi-cancer early detection (MCED) tests for otolaryngologists. PubMed, clinicaltrials.gov, company websites. Using PRISMA methodology, primary literature regarding MCED tests was queried from April 26 to May 12, 2024 using MCED search terms. Ongoing clinical trials incorporating MCED screens were identified via the National Institutes of Health clinicaltrials.gov website. Company websites for available or upcoming MCED tests were reviewed. Long-term robust data regarding the performance characteristics, effects on clinical outcomes, and cost-utility of MCED tests for head and neck cancer are currently lacking. Otolaryngologists should be aware of the implications of MCED tests as these assays become more widely used. Although not FDA-approved or covered by insurances at the time of writing of this manuscript, MCED testing is rapidly gaining interest, and patients with positive tests are presenting to otolaryngologists for evaluation. While MCED technologies hold great promise for early detection of disease and potential reduction of morbidity and mortality, more study is needed about their utility for head and neck cancer and optimal diagnostic workflows.

Serologic Evidence for Early SARS-CoV-2 Circulation in Lima, Peru, 2020.

During early 2021, Peru had the highest COVID-19-associated per-capita mortality rate. Socioeconomic inequality, insufficiently prepared healthcare, and surveillance systems are factors explaining the mortality rate, which can be severely worsened by early undetected SARS-CoV-2 circulation. We tested 1,441 individuals with fever sampled during August 2019-May 2021, several months before the first SARS-CoV-2 seroprevalence study available so far in Lima, Peru, for SARS-CoV-2-specific antibodies. The testing algorithm included a chemiluminescence immunoassay and surrogate virus neutralization test. Early positive samples (N = 24) from January-March 2020 were further tested using a plaque-reduction neutralization test (PRNT) and avidity test against the SARS-CoV-2 spike and nucleoprotein. None of the early samples were PRNT-confirmed, in contrast to 81.8% (18/22) of a subsample from April 2020 onward (Fisher exact test; P <0.0001). Therefore, we excluded non-PRNT-confirmed samples from subsequent analyses. The SARS-CoV-2 antibody detection rate was 0.9% in mid-April 2020 (1/104; 95% CI: 0.1-5.8%), suggesting viral circulation in early-middle March 2020, consistent with the first molecular detection of SARS-CoV-2 in Peru on March 2020. Mean avidity increase of 62-77% to 81-94% from all PRNT-confirmed SARS-CoV-2-positive samples during early 2020 were consistent with onset of SARS-CoV-2 circulation during late February/March 2020. Early circulation was also confirmed in a susceptible, exposed, infected, and recovered mathematical model that calculated an effective reproduction number >1 during February-March 2020. Early introduction of SARS-CoV-2 thus contributed to the high COVID-19 mortality rate in Peru. Emphasizing the role of diagnostic confirmation in understanding the pandemic's trajectory, this study highlights the importance of early detection and accurate testing in managing infectious disease outbreaks.

A Targeted Methylation-Based Multicancer Early Detection Blood Test Preferentially Detects High-Grade Prostate Cancer While Minimizing Overdiagnosis of Indolent Disease.

Indolent prostate cancer (PCa) is prevalent in the intended use population (adults age 50-79 years) for blood-based multicancer early detection (MCED) tests. We examined the detectability of PCa by a clinically validated, targeted methylation-based MCED test. Detectability by Gleason grade group (GG), clinical stage, association of detection status with tumor methylated fraction (TMeF), and overall survival (OS) were assessed in substudy 3 of Circulating Cell-Free Genome Atlas (CCGA; ClinicalTrials.gov identifier: NCT02889978) and PATHFINDER (ClinicalTrials.gov identifier: NCT04241796) studies. Test sensitivity for PCa in substudy 3 of CCGA was 11.2% (47/420). The test detected 0 (0%) of 58 low-grade (GG1), 3 (1.9%) of 157 favorable intermediate-grade (GG2), 4 (5.1%) of 78 unfavorable intermediate-grade (GG3), and 36 (31.9%) of 113 high-grade (GG4 and 5) cancers and 3 (3.2%) of 95 stage I, 11 (4.7%) of 235 stage II, 7 (14.9%) of 47 stage III, and 22 (81.5%) of 27 stage IV cases. The median TMeF was higher for detected than nondetected cases (2,106.0 parts per million [PPM]; IQR, 349.8-24,376.3 v 24.4 PPM; IQR, 17.8-38.5; P < .05). Nondetected cases had better OS (P < .05; hazard ratio [HR], 0.263 [95% CI, 0.104 to 0.533]) and detected cases had similar survival (P = .2; HR, 0.672 [95% CI, 0.323 to 1.21]) compared with SEER adjusted for age, GG, and stage. Performance was similar in PATHFINDER, with no detected GG1/2 (0/13) or stage I/II (0/16) cases. This MCED test preferentially detects high-grade, clinically significant PCa. Use in population-based screening programs in addition to standard-of-care screening is unlikely to exacerbate overdiagnosis of indolent PCa.

Evolution of Liquid Biopsies for Detecting Pancreatic Cancer.

Pancreatic ductal adenocarcinoma (PDAC) is a lethal malignancy characterised by late diagnosis and poor prognosis. Despite advancements, current diagnostic and prognostic strategies remain limited. Liquid biopsy techniques, including circulating tumour DNA (ctDNA), circulating tumour cells (CTCs), circulating tumour exosomes, and proteomics, offer potential solutions to improve PDAC diagnosis, prognostication, and management. A systematic search of Ovid MEDLINE identified studies published between 2019 and 2024, focusing on liquid biopsy biomarkers for PDAC. A total of 49 articles were included. ctDNA research shows some promise in diagnosing and prognosticating PDAC, especially through detecting mutant KRAS in minimal residual disease assays. CTC analyses had low sensitivity for early-stage PDAC and inconsistent prognostic results across subpopulations. Exosomal studies revealed diverse biomarkers with some diagnostic and prognostic potential. Proteomics, although relatively novel, has demonstrated superior accuracy in PDAC diagnosis, including early detection, and notable prognostic capacity. Proteomics combined with CA19-9 analysis has shown the most promising results to date. An update on multi-cancer early detection testing, given its significance for population screening, is also briefly discussed. Liquid biopsy techniques offer promising avenues for improving PDAC diagnosis, prognostication, and management. In particular, proteomics shows considerable potential, yet further research is needed to validate existing findings and comprehensively explore the proteome using an unbiased approach.

Noninvasive multi-cancer detection using blood-based cell-free microRNAs.

Patients diagnosed with early-stage cancers have a substantially higher chance of survival than those with late-stage diseases. However, the option for early cancer screening is limited, with most cancer types lacking an effective screening tool. Here we report a miRNA-based blood test for multi-cancer early detection based on examination of serum microRNA microarray data from cancer patients and controls. First, a large multi-cancer training set that included 1,408 patients across 7 cancer types and 1,408 age- and gender-matched non-cancer controls was used to develop a 4-microRNA diagnostic model using 10-fold cross-validation. In three independent validation sets comprising a total of 4,875 cancer patients across 13 cancer types and 3,722 non-cancer participants, the 4-microRNA model achieved greater than 90% sensitivity for 9 cancer types (lung, biliary tract, bladder, colorectal, esophageal, gastric, glioma, pancreatic, and prostate cancers) and 75-84% sensitivity for 3 cancer types (sarcoma, liver, and ovarian cancer), while maintaining greater than 99% specificity. The sensitivity remained to be > 99% for patients with stage 1 lung cancer. Our study provided novel evidence to support the development of an inexpensive and accurate miRNA-based blood test for multi-cancer early detection.

Abstract B083: Community-based knowledge-to-action translation to improve early detection of prostate cancer among Black individuals

Abstract Introduction: Black individuals have 70-80% higher incidence and 120% higher mortality from prostate cancer when compared to all other groups in the US. This is the largest racial disparity in cancer-related mortality in the US and has persisted over the last five decades despite improvements in the diagnosis and treatment of prostate cancer. Our previous work demonstrated that intensified screening practices could reduce prostate cancer mortality among Black individuals. Challenges impede the translation of these findings into real-world interventions and practices. The objective of this study was to design a patient-centered and culturally tailored knowledge toolkit to improve the knowledge and awareness of prostate-specific antigen (PSA) testing in Black individuals to facilitate informed shared-decision making between Black patients and primary care providers. Methods: Using a community-partnered participatory research approach, we convened a working group of Black prostate cancer survivors and community advocates, and clinicians, researchers, and health communications specialists. During monthly meetings, the working group followed Graham’s Knowledge-to-Action framework to synthesize information from: 1) peer-reviewed literature on the use of shared decision-making aids; 2) interviews conducted by our research team with Black individuals regarding barriers and facilitators to access PSA testing; and 3) community input on PSA testing and prostate cancer early detection. We then facilitated four iterative design sessions with the working group to develop recommendations for toolkit content, framing, and format. Results: With the working group, we designed a comprehensive set of resources to increase knowledge and awareness of PSA testing for early detection of prostate cancer among Black individuals. The design framework includes detailed recommendations on the content, framing, and format for resources contained in the toolkit. Recommendations encompass: 1) interactive web-based documents that cover comprehensive information about prostate cancer risk and screening; 2) printable shared decision-making documents that present evidence-based information about the use of PSA testing to guide conversations between Black individuals and their primary care providers; and 3) educational videos focused on prostate cancer fundamentals and dispelling common misconceptions about prostate cancer risk and screening, with content delivered by Black prostate cancer survivors and interviews with Black providers and prostate cancer researchers. Conclusion: This study addressed the need for a community-developed approach to increasing knowledge and awareness about prostate cancer screening and early detection in an accessible, culturally tailored, and accurate manner. We used a collaborative process that centered the experiences of Black prostate cancer survivors and advocates in the design of a toolkit that can facilitate decision-making discussions between Black individuals and their care providers for use of PSA testing for prostate cancer screening. Citation Format: Jenney R. Lee, Sung Min Kim, Yohali Burrola- Mendez, Dante' Morehead, Marty Chakoian, Michael Ware, Kojo Ward, Floyd Gossett, Vida Henderson, Patricia Egwuatu, Burcu Darst, John Masembe, Erika M. Wolff, Yaw A Nyame. Community-based knowledge-to-action translation to improve early detection of prostate cancer among Black individuals [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B083.

Abstract B025: Surveillance outcome in individuals at high risk of pancreatic cancer

Abstract INTRODUCTION: Pancreatic ductal adenocarcinoma (PDAC) has a poor 5-year survival rate. PDAC surveillance is recommended in high-risk individuals (HRIs) with strong PDAC family history or a pathogenic germline variant (PGV) in a PDAC susceptibility gene. We aimed to explore a potential correlation between genetic status, extent of family history, pancreatic findings, and surveillance implications in heterogeneous PDAC HRIs. METHODS: from January 2015 up to date, a total of 340 HRIs from 291 families visited our pancreatic cancer high-risk clinic. Surveillance included annual clinic visits, EUS/MRI imaging, genetic and laboratory blood testing. Participants completed a questionnaire that included personal and familial medical history, dietary habits, daily activities with emphasis on smoking habits, alcohol use, and physical activity. RESULTS: Our cohort was divided into 3 groups: familial pancreatic cancer that include individuals with family history of 2 or more first degree family (FDR) with PDAC (FPC; 96 individuals), familial non-FPC, families with at least 2 biological relatives with PDAC and not meeting FPC criteria, (119 individuals), and hereditary pancreatic cancer (PC), individuals with PGV in a PC susceptibility gene and a family member with PDAC carrying the same PGV (124 individuals). The cohort average age at first visit was 54 years with 44% male and 56% female ratio. Seventy percent of the cohort was of Jewish Ashkenazi decent. Genetic testing was performed in several steps, first BRCA1/2 founder mutations was performed in all individuals followed by genetic panels and whole exome sequencing (WES). PGVs were detected in 36.4% of all families. There was no significant difference in the genetic finding between the FPC and non-FPC groups (11% and 9.6% respectively). Of the study cohort 35% were screened by EUS and 8% by MRI/MRCP. Pancreatic lesions detected included 11 cases of new PDAC (3.2%), 69 cystic lesions (20.3%), 43 cases early chronic pancreatitis (12.6%) and 11 cases of main pancreatic duct dilation (3.2%). To better understand the risk of PDAC development in HRIs we recently added a novel cell-free chromatin blood test for early cancer detection (in collaboration with SENSEERA, Israel) and compared it to EUS imaging results. The test provides multidimensional epigenetic information that sheds light on the identity and the transcriptional state of the cells that are dying in the body of the patient. Our preliminary results show nice separation between the healthy control and PC groups. PC HRIs show slight increase in score compared to the general population while individuals with worrisome features show substantial increase compared to HRIs with no EUS findings. DISCUSSION: Surveillance seems effective for detection of early-stage PDAC and precursor lesions. However, screening strategy can be improved by adding newer modalities like chromatin-based tests that might help to further define the risk of cancer development in HRIs. Citation Format: Merav Ben Yehoyada, Erez Scapa, Oren Shibolet, Guy Rosner. Surveillance outcome in individuals at high risk of pancreatic cancer [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer Research; 2024 Sep 15-18; Boston, MA. Philadelphia (PA): AACR; Cancer Res 2024;84(17 Suppl_2):Abstract nr B025.

Development and Diagnosis Performance of IgM-Based Rapid Antigen Test for Early Detection of SARS-CoV-2 Infection in a Large Cohort of Suspected COVID-19 Cases - USA, Poland, and Sweden, 2021-2022.

Antigen testing has been crucial in effectively managing the coronavirus disease 2019 (COVID-19) pandemic. This study evaluated the clinical performance of a nasopharyngeal swab (NPS)-based antigen rapid diagnostic test (Ag-RDT) compared to the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) for early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We developed an IgM-based rapid antigen test for early detection of SARS-CoV-2 infection. Between July 2021 and January 2022, we analyzed 1,030 NPS samples from participants at three centers in different countries, using both antigen rapid diagnostic tests (Ag-RDT) and RT-PCR. The Ag-RDT demonstrated minimal detection limits as low as 0.1 ng/mL for recombinant N antigen and 100 TCID50/mL for heat-inactivated SARS-CoV-2 virus. Specificity assessments involving four human coronaviruses and 13 other respiratory viruses showed no cross-reactivity. The Ag-RDT assay (ALLtest) exhibited high sensitivity (93.18%-100%) and specificity (99.67%-100%) across all centers. Factors such as cycle threshold (Ct) values and the timing of symptoms since onset were influential, with sensitivity increasing at lower Ct values (<30) and within the first week of symptoms. The ALLtest Ag-RDT demonstrated high reliability and significant potential for diagnosing suspected COVID-19 cases.

A consultation and work-up diagnosis protocol for a multicancer early detection test: a case series study.

The emergence of multicancer early detection (MCED) tests holds promise for improving early cancer detection and public health outcomes. However, positive MCED test results require confirmation through recommended cancer diagnostic imaging modalities. To address these challenges, we have developed a consultation and work-up protocol for definitive diagnostic results post MCED testing, named SPOT-MAS. Developed through circulating tumor DNA (ctDNA) analysis and in line with professional guidelines and advisory board consensus, this protocol standardizes information to aid general practitioners in accessing, interpreting and managing SPOT-MAS results. Clinical effectiveness is demonstrated through a series of identified cancer cases. Our research indicates that the protocol could empower healthcare professionals to confidently interpret circulating tumor DNA test results for 5 common types of cancer, thereby facilitating the clinical integration of MCED tests.

Genomic-Based Early Detection Screening: A Literature Review of Prospective Trials and Emerging Strategies for Gastrointestinal Cancers.

Numerous genomic-based early detection screening tests are being developed. These tests have the potential to revolutionize current single-organ screening paradigms, especially in gastrointestinal cancers. In this review, we underscore the performance of these genomic-based early detection tests based on prospective clinical trials. Moreover, we discuss a professional advancement for gastroenterologists in the diagnostic assessment of individuals who are cancer signal positive.

1188P Modeled economic and clinical impact of a multi-cancer early detection (MCED) test in a population with hereditary cancer syndromes

1188P Modeled economic and clinical impact of a multi-cancer early detection (MCED) test in a population with hereditary cancer syndromes

1184P Early real-world experience with positive multi-cancer early detection (MCED) test cases and negative initial diagnostic work-up

1184P Early real-world experience with positive multi-cancer early detection (MCED) test cases and negative initial diagnostic work-up

1183P Impact of multicancer early detection (MCED) test on participant-reported outcomes (PRO) and behavioral intentions by cancer risk

1183P Impact of multicancer early detection (MCED) test on participant-reported outcomes (PRO) and behavioral intentions by cancer risk