StartUPDATES: New developments for healthcare startups

Check out news from healthcare startups including Truvian Sciences and Seven Bridges Genomics.

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This week, Truvian Sciences unveiled the results of a first of its kind research study validating the performance and accuracy of the Easy Check COVID-19 IgM/IgG antibody test. The clinical study, led by Jerry Yeo, PhD, DABCC, FAACC, Professor of Pathology at the University of Chicago, was published today in The American Journal of Clinical Pathology, revealing one of the highest overall accuracy rates for SARS-CoV-2 antibody detection via lateral flow technology.

While serological assays have become increasingly available for surveillance via the Food and Drug Administrations’ (FDA) Emergency Use Authorization (EUA), reports of faulty or inaccurate tests underscore the need for rapid COVID-19 antibody tests to be thoroughly validated prior to their implementation. Truvian is leading this charge to ensure its diagnostic devices are validated by rigorous testing and sound science, including this independent analytical and clinical validation of Easy Check by Dr. Yeo.

During the study, Easy Check, which received emergency use authorization (EUA) by the FDA in late July, showed excellent clinical performance with a sensitivity of 96.6%, specificity of 98.2% and an overall accuracy of 98.1%. The study also demonstrated that the Easy Check device is a simple, fast, and reliable platform for detection of seropositivity of SARS-CoV-2 at ten minutes after test initiation for either plasma, serum, or whole blood samples. Easy Check performance was tested against Roche’s Elecsys anti-SARS-CoV-2 antibody assay and showed an overall concordance of 98.6% – demonstrating it compares very well with large lab-based serology analyzers.

Seven Bridges has announced participation in the Data Management and Portal for INCLUDE (DAPI) Project. The National Institutes of Health (NIH) INCLUDE Project (Investigation of Co-occurring conditions across the Lifespan to Understand Down syndrome) aims to improve the quality of life for persons with Down syndrome, helping better understand their susceptibility to disease and to aid in the development of new therapies needed to treat conditions afflicting this population. The INCLUDE Project aims to accelerate targeted basic research studies, cohort studies, and inclusion in clinical trials to create a “medical home” for individuals with Down syndrome.

The DAPI Project will create a centralized platform for health and genomic information collected by Down syndrome researchers. The platform will empower scientists, physicians, and the community with tools to elicit evidence-based action in the laboratory, clinic, classroom, government, and society at-large. As part of the project, Seven Bridges CAVATICA is providing a link between the data portal and the data management systems that will enable users to make new connections.

“Our participation in this project demonstrates the strength of CAVATICA as a solution that can enable data-driven discovery across therapeutic categories and disease states by breaking down barriers that hamper the development of precision medicine,” said Jack DiGiovanna, Ph.D., Senior Vice President and Director of Programs at Seven Bridges. “This project is leveraging CAVATICA in a new way to integrate and make actionable insights available from a variety of data types including clinical data, images, biospecimen data, as well as multi-omics information.”

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