One Retrospective Cohort, One Prospective Cohort, in Total of ~2,400 Cancer Patients and Non-cancer Individuals Demonstrate the Performance of SeekInCare Test to Detect Multiple Cancer Types and Predict Tissue of Origin of Cancers
The Achievement of 65.5% Sensitivity at 97.9% Specificity in the Retrospective Study and 60.0% Sensitivity at 96.1% Specificity in the Prospective Study Places SeekInCare among the Best-in-Class in Non-invasive Multi-cancer Early Detection
SHENZHEN, China, Nov. 10, 2023 /PRNewswire/ — SeekIn Inc., a leader in blood-based pan-cancer early detection and monitoring technology, today announced the validation studies consisting of one retrospective cohort and one prospective cohort that evaluate SeekInCare’s ability to detect cancer patients and predict the tissue of origin with one tube of blood. The results demonstrate the performance of SeekInCare with the consistent results among the two cohorts in ~2,400 cancer patients and non-cancer individuals. SeekInCare achieved overall 65.5% sensitivity at 97.9% specificity in the retrospective studies and 60.0% sensitivity at 96.1% specificity in the prospective cohort study, respectively, which is best-in-class in blood-based multi-cancer early detection (MCED). The findings were presented at the 20th ICGC Workshop and 7th ARGO Meeting in New York.
“Recent studies have demonstrated that blood-based multi-cancer early detection approaches may hold promise for identifying asymptomatic cancer patients from general population. However, most studies only exploit a single aspect of cancer hallmarks, which is challenging to achieve highly sensitive results because cancer is a heterogenous disease,” said Mao Mao, MD, PhD, Founder and CEO of SeekIn. “For example, our OncoSeek test for multi-cancer early detection was designed with seven protein tumor markers. With the assistance of artificial intelligence (AI), the sensitivity of OncoSeek was 51.7% at 92.9% specificity. While OncoSeek significantly reduced false positive rates comparing with traditional methods, we believe sensitivity can be further improved when more omics data are included. And this is how SeekInCare was conceived.”
SeekInCare was developed using proprietary AI- and big data-driven algorithm to distinguish cancer patients from non-cancer individuals by calculating cancer risk score (CRS) incorporating copy number aberrations (CNAs), fragment size (FS), end motifs and oncogenic viruses via shallow whole genome sequencing (sWGS) from cell-free DNA (cfDNA), and seven plasma tumor markers (PTMs), and to predict the possible affected tissue of origin (TOO) for those who have been detected with cancer signals in blood. SeekInCare’s performance was well-demonstrated by the overall 65.5% sensitivity at 97.9% specificity in the retrospective study and 60.0% sensitivity at 96.1% specificity in the prospective study. A critical attribute of a blood-based multi-cancer detection test is the ability to localize the TOO to direct the diagnostic workup. The overall accuracy of two most possible organs SeekInCare achieved was 85.4%, improved by 20.0% from OncoSeek.
“In addition to the performance improvement of SeekInCare in TOO prediction comparing with OncoSeek, significant improvements were also observed in major metrics such as sensitivity, specificity and accuracy. Unlike OncoSeek designed for low- and middle-income countries, SeekInCare enables us to provide a more sensitive and specific multi-cancer detection solution to the regions with purchasing power and high demands of advanced cancer screening,” said Dr. Mao. “More importantly, comparing with the results of both retrospective and prospective studies from GRAIL and Exact Sciences, SeekInCare showed higher sensitivities with similar specificities.”
The excellent consistency of validation results from both retrospective and prospective studies established SeekInCare’s clinical feasibility. With these achievements, SeekIn is planning for future investigation of SeekInCare’s clinical utility as a large-scale cancer screening test in average-risk populations.
SeekIn Inc. is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since its creation, SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection, postoperative recurrence monitoring, and treatment response evaluation. SeekIn also developed novel molecular tests for leukemia patients. With its proprietary technical advances, SeekIn has launched a number of research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that, by leading a new norm for cancer early detection, the clinical outcome of mid-/late-stage cancer patients can be reversed, and the cancer mortality rate can be reduced by 15%. For more information about SeekIn’s cutting-edge technologies and products, visit www.seekincancer.com.
SeekInCare has been developed as a multi-cancer early detection (MCED) test that takes a panoramic view of blood cell-free cancer signatures and a multi-omics approach incorporating genomic and epigenetic alterations in conjunction with clinically validated protein biomarkers. Equipped with proprietary AI- and big data-driven CRS algorithm, SeekInCare exhibits superior effectiveness to detect cancer at high specificity. SeekInCare is intended to use for the individuals with elevated risks of cancer such as smoking, chronic hepatitis, aging, etc., in conjunction with the approved conventional single cancer type screening tests.SeekInCare is CE-IVD certified.