Cofactor Genomics Validates OncoPrism-HNSCC Test for Immunotherapy Response Prediction

Cofactor Genomics, Inc., a clinical-stage company focusing on precision medicine through RNA decoding, has announced significant results from their PREDAPT clinical trial (NCT04510129) concerning head and neck squamous cell carcinoma (HNSCC). Their findings were published in the Journal for ImmunoTherapy of Cancer, highlighting the clinical validity and utility of the OncoPrism-HNSCC test. This Medicare-reimbursed test aims to predict the benefit of immune checkpoint inhibitors (ICI) for patients.

The multicenter study revealed that OncoPrism-HNSCC improved specificity by 300% over PD-L1 CPS and sensitivity by 400% over Tumor Mutational Burden (TMB) in predicting patient benefit from ICI. PD-L1 and TMB have shown limitations, often leading to over-treatment and poorer outcomes for HNSCC patients. Dr. Douglas Adkins, a head and neck oncologist and professor at Washington University School of Medicine, stated that the OncoPrism assay provides a vital tool for clinicians to make informed decisions regarding treatment options for patients with recurrent or metastatic head and neck cancer. OncoPrism-HNSCC effectively bridges the precision medicine gap by offering clinicians crucial data for better treatment decisions.

The study, titled “Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study,” demonstrated that OncoPrism-HNSCC accurately predicted disease control and progression-free survival in patients treated with ICI, either alone or in combination with chemotherapy. This not only suggests potential improvements in patient outcomes but also highlights the health economic benefits by ensuring that more patients receive the most effective personalized treatment.

Dr. Eric Duncavage, Cofactor Genomics’ Medical Director, emphasized that this study illustrates the ongoing advancements in molecular technologies driving precision medicine. Cofactor’s Health Expression Models represent a new category of diagnostic technologies. These models use RNA expression and machine learning to measure the body’s immune response to cancer, thus providing a better prediction of immunotherapy treatment responses in cancer patients. Cofactor’s precision diagnostics enable a level of specificity that other technologies lack.

Cofactor Genomics is a clinical-stage diagnostics company dedicated to bridging the precision medicine gap by decoding RNA to address significant healthcare challenges. Their approach utilizes the PRISM database of patented Health Expression Models (HEMs), which go beyond the common gene mutation panel tests. HEMs incorporate advancements in machine learning and RNA to transform vast amounts of biological RNA data into high-dimensional models of biology, disease, and therapy response.

Cofactor's innovative RNA modeling work has been recognized and published in several prestigious journals, including The Journal of ImmunoTherapy of Cancer and The Journal of Molecular Diagnostics. Their pioneering efforts have also been acknowledged by Nature Scientific Reports as groundbreaking in cancer research. Cofactor is supported by partnerships with 38 healthcare systems, encompassing 20% of US healthcare. Their OncoPrism test is both CAP/CLIA-validated and Medicare-approved.