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PR-Sapere measures senescence and physiologic reserve
Our first product, PR-Sapere, is based on technology pioneered in the UNC laboratory of Dr. Ned Sharpless, currently FDA Director. The Sharpless lab established that measuring p16 in T-cells isolated from venous blood captures life experiences of individuals - changing with age, lifestyle, clinical interventions and disease. Translating these breakthroughs into a commercially viable assay, we optimized p16 measurement, completed extensive analytical validation (QA/QC), and developed blood preservation technology to establish Sapere Bio as the trusted source to quantify p16 expression.
Clinical research collaborations generate insights
Sapere Bio is building a portfolio of academic research collaborations with leading physician scientists. These collaborations build the scientific foundation for understanding how physiologic reserve and senescence affect health. They generate clinical insights that shape additional research and, ultimately, our pipeline of LDTs. To-date, PR-Sapere has been used in 16 prospective trials on over 5,000 patient samples.
Sapere Bio innovates through scientific and clinical expertise
Sapere Bio has an evolving panel of physiologic reserve biomarkers (beyond p16) that we measure on our biobank of clinical samples. Our scientists and biostatisticians analyze both biomarker and clinical data to create algorithms that predict patient outcomes. From these insights, we prioritize the best opportunities to develop actionable, game-changing diagnostics.
Clinically validated, actionable LDTs benefit patients and clinicians
We validate the most promising diagnostics in prospective clinical studies and commercialize highly predictive LDTs (lab developed tests). Our products guide critical clinical decisions - augmenting physician expertise to improve patient outcomes and reduct costs.
Our second product, AKI-Sapere, is an LDT that stratifies patients by risk of acute kidney injury (AKI) before cardiac surgery. Acute kidney injury affects 30% of the ~200,000 US patients undergoing CABG (coronary artery bypass graft) surgery annually. There are no treatments and prevention is difficult because surgeons cannot currently identify at-risk patients. AKI dramatically increases hospital costs and results in poor short- and long-term outcomes including ESRD. AKI-Sapere identifies at-risk patients before surgery for prophylaxis with 80% sensitivity. Validation is ongoing in an ~800-patient study.