SeekIn has announced the clinical validation of its non-invasive multi-omics blood test, SeekInCare, intended for the early identification of various cancers, in a study published in the Journal of Molecular Diagnostics.

Developed by the company’s researchers, the test utilises shallow whole-genome sequencing of cell-free DNA (cfDNA) and integrates epigenetic, proteomic and genomic analyses to identify early-stage cancer.

Findings from the study show that SeekInCare will measure seven protein tumour markers from 8ml of peripheral blood.

The test also analyses several cancer hallmarks, inclusive of copy number aberration, size of the fragment, oncogenic virus, and end motif, paired with AI algorithms to differentiate those with cancer from non-cancer ones and predict the potential tissue of origin.

SeekIn noted that in a retrospective trial with 617 cancer subjects and 580 non-cancer participants, the test achieved a 60% sensitivity at 98.3% specificity, with an area under the curve (AUC) of 0.899.

The test’s real-world evidence was supported by a prospective cohort comprising 1,203 subjects, where it achieved a 70% sensitivity at a 95.2% specificity over a 753-day median follow-up.

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SeekIn CEO and founder Dr Mao Mao said: “Our findings demonstrate that integrating multiple molecular signatures from blood can significantly enhance the sensitivity and specificity of early cancer detection.

“SeekInCare’s robust performance in both retrospective and prospective cohorts supports its potential clinical utility as a screening tool, particularly for high-risk populations.”

Intended for use in individuals with increased risk of cancer, the test is to be used in combination with conventional approved single-cancer type screening tests.

SeekInCare secured the CE In Vitro Diagnostic (IVD) Mark in November 2021.

In 2023, the company entered a strategic partnership with Oncolnv to expand the global accessibility of its multiple cancer detection tests.

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