Singlera Genomics and Fudan University unveiled results demonstrating detection of five common cancers earlier than standard test

SAN DIEGOandSHANGHAI,July 21,2020 --Fudan University's Taizhou Health Science Institute and Singlera Genomics,focused on non-invasive early cancer detection,today announce the publication of a peer reviewed manuscript demonstrating the initial results from the Taizhou Longitudinal Study (TLS),showing Singlera's PanSeer assay can detect five types of cancer up to four years before conventional diagnosis with a single blood draw.Some results from this study were also presented at the AACC 71st Annual Scientific Meeting heldAugust 4-8 2019inAnaheim,California,and selected as one of three finalists in the Disruptive Technology Award competition.

This collaborative study was a joint effort between Singlera Genomics with Professor Kun Zhang at the University of California San Diego,and Professor Li Jin at Fudan University.

The TLS study was launched by Professor Li Jin of Fudan University and began in 2007 collecting plasma samples from over 120,000 healthy individuals. Study participants were monitored for a 10-year period through linkages with local cancer registries and health insurance databases. Over 1.6 million specimens have been collected and archived to date.

"We really appreciate the reviewers and the editor for scrutinizing our study very carefully as this is one of the first retrospective longitudinal studies that demonstrates blood based non-invasive early detection of multiple cancer types four years before conventional diagnosis," said Yuan Gao,Ph.D.,one of senior authors of the study and co-founder and Chairman of Singlera Genomics. Rui Liu,another senior author on the paper and co-founder/CTO of Singlera Genomics,added,"one unique aspect is that we use a longitudinal cohort with 10+ years of efforts to show detection of cancer before conventional diagnosis is possible,while previous work has mostly focused on a case-control design with symptomatic cancer patients that have already been diagnosed with the standard care. It is excited to see that cancer signatures can be detected so early in as little as 1ml plasma with Singlera's PanSeer assay."

Professor Kun Zhang said: "I am very pleased to see that early developments of DNA methylation methods in my laboratory at UCSD were further improved and optimized at Singlera,leading to the PanSeer assay that is both robust and accurate in detecting cancers in blood early." Professor Li Jin said: "This study demonstrated that a large cohort such as TLS could offer a powerful tool for evaluating technologies for early and precision diagnoses."

The next logic phase would be a prospective cohort study and clinical trial.However,the difficulty for prospective study is the length of time and the amount of resource involved.Singlera Genomics is in the process of raising additional funds for this purpose.Furthermore Singlera Genomics has also met with FDA twice for its blood-based colorectal cancer colonES assay and is expected to launch the trial in the near future. The research team is in the process of extending this early detection approach to additional cancer types,and Singlera is currently looking for collaboration partners in the United States.

Fudan University(http://www.fudan.edu.cn/en/)

Fudan University,established in 1905,is located inShanghai,China. The name "Fudan" originated from a famous statement,meaning unremitting effort. Fudan University comprises 17 full-time schools (including 66 specialties) and 69 departments across 4 campuses. It has 68 specialties for Bachelor's Degree Candidates,209 specialties for Master's Degree Candidates,and 157 specialties for Doctoral Degree Candidates. It has nearly 44,300 students,including full-time students,students in Continuing Education or Network Education,as well as overseas students.

Singlera Genomics Inc.(www.singlera.com)

Singlera Genomics Inc.,a company focusing on non-invasive genetic diagnosis,was co-founded inJuly 2014inSan Diego,California. The company currently has R&D centers and business operations in bothLa Jolla,andShanghai,China. Singlera has proprietary technologies in single cell sequencing,DNA methylation,and bioinformatics.

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