Guardian Genomics develops genetics-guided cell-free RNA blood tests. Our first product, CardioGuardian, is a patent-pending blood test that measures cell-free RNA from genetically regulated risk genes, to detect cardiovascular disease that clinical risk scores miss.
Equations such as PREVENT estimate risk from a handful of clinical factors.
Many patients with disease are rated low or borderline risk.
They capture genetics, but they are fixed at birth and were built mostly in European-ancestry cohorts.
They can't tell whether risk genes are actually active.
Imaging shows plaque directly, but it requires a separate visit and radiation exposure.
It sees disease once structure has changed.
CardioGuardian, our first test, reads the activity of the genes that drive inherited cardiovascular risk, from a single routine blood draw.
We link cardiovascular GWAS risk variants to the genes they regulate in artery tissue, using a regulatory trait concordance method applied to GTEx eQTL maps of coronary artery and aorta.
GWAS × eQTLCells in the artery wall and immune system shed RNA into the bloodstream. From one plasma sample, we sequence the cell-free RNA of those risk genes.
Plasma cfRNAEach gene's expression is weighted by its genetic effect, producing a single CardioGuardian score designed to complement clinical risk equations.
One scorePatients profiled by plasma cell-free RNA in our training cohort
Of the cohort from non-European ancestry
Carotid artery tissue samples in an independent public dataset used for validation
Risk variant–gene pairs active in coronary artery, used to select our genes
The CardioGuardian score was significantly higher in patients with cardiovascular disease than in those without.
It outperformed a polygenic risk score in the same cohort and added information beyond the PREVENT clinical risk score.
It flagged patients with disease even when their clinical risk was rated low or borderline.
We are expanding independent validation in additional patient cohorts, toward 500 samples, and moving from exome-wide sequencing to a compact targeted panel already designed for lab transfer.
Results from a cross-sectional cohort; manuscript currently in peer review. CardioGuardian is an investigational research assay. It has not been cleared or approved by the U.S. FDA and is not available for clinical use.
Built the CardioGuardian cfRNA assay and model. Previously developed a colorectal cancer NGS assay now commercialized as ColonAiQ and managed companion-diagnostic partnerships at Hengrui Pharmaceutical.
Assistant Professor of Radiation Oncology at Stanford. Leads research on liquid biopsy and the cardiovascular effects of cancer therapy, where CardioGuardian began.
Bioinformatician who co-led the genetic and clinical analyses behind CardioGuardian, including benchmarking against polygenic and clinical risk scores and tissue validation.
Head of AI Product at Noetik. Developed the regulatory trait concordance algorithms that link disease-risk variants to the genes they regulate in specific tissues, and co-developed the CardioGuardian scoring model.
Associate Professor at Stanford University School of Medicine, with appointments in Cardiovascular Medicine and Pediatric Cardiology. Co-author of the CardioGuardian study.
Guardian Genomics is speaking with clinical labs, cardiologists, research collaborators, and investors. We'd love to hear from you.
Email the team