Promising outlook for prognostic biomarkers related to HFpEF
The FDA states: ”We encourage exploration of the biomarker PRO-C6* as a prognostic biomarker to be used to enrich HFpEF clinical trials with a more homogenous patient subset who are more likely to experience outcome”.
Enrichment of clinical trials with the right patients is a huge unmet medical need in HFpEF, and the FDA recognizes that PRO-C6* has shown promising findings for facilitating trial enrichment.
These are huge steps in our mission to provide a meaningful difference in patients’ lives by increasing high quality and robustness and towards enabling clinical decision making.
PRO-C3* and PRO-C6* have shown to be essential in chronic diseases in which fibroblast activity is of key importance, for prognosis of disease progression and outcomes, as well as having predictive and pharmacodynamic properties. They can now be measured on the Roche high precision platform, with high sensitivity and stability.
This is part of a big quality initiative to leverage the proven ability of our biomarkers in drug development and decision-making for enabling patient selection and pharmacodynamic assessments. We are advancing more markers from RUO to IVDs to allow for the quality needed to support drug development.
You can read more about the FDA's Letter of Support program on this link, where you can also find our biomarker at the bottom of the page.
