The FDA supports a biomarker for aggressive fibrotic tumors

The FDA supports a biomarker for aggressive fibrotic tumors

Source: Nordic Bio

The FDA has granted its backing to a blood test that may be able to determine if a solid tumor would be particularly aggressive.

PRO-C3, a peptide produced from type III collagen while it is being created and being researched as a biomarker for various disorders, including non-alcoholic fatty liver disease (NAFLD), is detected by the experimental test from the Danish biotech company Nordic Bioscience.

The FDA has granted Nordic Bio a “letter of support,” which acknowledges the potential of a biomarker and encourages additional research. The FDA describes it as a strategy to “enhance the visibility of the biomarker, encourage data sharing, and stimulate additional studies,” rather than as an endorsement or validation in and of itself.

The FDA has so far distributed a few dozen letters of support as part of a plan to encourage the discovery of novel biomarkers that may be used to facilitate medication development and enable more focused therapy.

At the time, a tissue biopsy, staining it to highlight collagen, and microscopic examination of the sample were the only ways to identify fibrosis in tumors. A blood test would be simpler to use in a clinical setting, and the capacity to identify individuals who are more likely to experience events might lower the sample sizes required for trials to demonstrate an impact.

“PRO-C3 may establish itself as the first blood-based fibrosis biomarker for individuals with aggressive solid tumors, and that the FDA’s approval will allow for further evaluation of its assay. This recognition aligns with our belief in the biomarker’s potential. Ultimately, this is all about helping patients fight cancer by supporting drug developers in bringing treatments to market faster and at a lower cost.”

Morten Karsdal, CEO of Nordic Bio

PRO-C3 isn’t the only biomarker for which Nordic Bio has received FDA support, though.

The FDA sent a letter to the biotech in 2021 along with partners Bristol-Myers Squibb and the University of Pennsylvania regarding PRO-C6, a peptide released during type V collagen synthesis that may be able to predict patient outcomes in clinical trials with heart failure and preserved ejection fraction (HFpEF).

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