SAINT LOUIS, Mo.--(BUSINESS WIRE)-- Cofactor Genomics, the company bridging the precision medicine gap, today announced successful validation of the OncoPrism immunotherapy predictive diagnostic assay, enabling physicians to use the test to help guide treatment decisions for patients with metastatic or recurrent squamous cell carcinoma of the head and neck (HNSCC). The successful readout is announced on the heels of the yearly national PREDAPT Summit, where the participating institutions from across the country gathered and reviewed the study results. The assay was validated in independent HNSCC patient cohorts receiving anti-PD-1 inhibitors pembrolizumab and nivolumab both as a single agent and in combination with chemotherapy. This milestone clears the assay for nationwide clinical use in an interventional setting where doctors can now incorporate OncoPrism to help guide patient treatment in a landscape of multiple therapies, each benefiting a subset of the patient population.

“This is a proud day for all those working tirelessly to bring precision medicine to immunotherapy and improve the outcome and quality of care for patients. We have learned not only from the study’s validation results but from physicians across the nation who have had significant input on the study and the OncoPrism assay these last 3 years,” stated Jarret Glasscock, Cofactor’s CEO.

This validation announcement follows a publication earlier this year in the Journal of Cancer Research and Clinical Oncology, where Cofactor along with more than 20 participating institutions reported on OncoPrism’s capability to predict HNSCC patients’ response to anti-PD-1 immune checkpoint inhibitors. Cofactor’s broader work, on the technology’s ability to predict response to immune checkpoint inhibitors (ICI) across multiple cancers, was recognized by the Nature Publishing Group as the second most downloaded oncology paper of the year.

While the validation of OncoPrism in HNSCC patients was the focus of this week’s announcement, Cofactor’s national PREDAPT clinical trial is aimed at evaluating OncoPrism in 11 cancers including lung, head and neck, colorectal, breast, cervical, liver, kidney, esophageal and bladder. US healthcare systems supporting and participating in the PREDAPT trial collectively provide care to approximately 20% of the total US patient population.

About Cofactor Genomics

Cofactor Genomics is bridging the precision medicine gap by building diagnostic tools to match the right patient to the right treatment at the right time. Predicting patient response to therapy currently relies on isolated, single-analyte biomarkers that have failed to deliver accurate therapy response predictions, resulting in unnecessary healthcare costs, and most harmfully, negative outcomes for patients. Cofactor’s products use Predictive Immune Modeling, which leverages RNA data and machine learning to combine biological signals, creating multidimensional biomarkers to deliver on the promise of precision medicine.

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