SAINT LOUIS: Cofactor Genomics, Inc., a clinical-stage company bridging the precision medicine gap by decoding RNA, announced the publication of their analytical validation study of the OncoPrism®-HNSCC test on the heels of its successful clinical validation and Medicare Reimbursement. OncoPrism-HNSCC predicts benefit from immune checkpoint inhibitors (ICIs) for patients with recurrent/metastatic squamous cell carcinoma of the head and neck, a critically needed tool for a patient population where only about 10-15% respond to ICI monotherapy. OncoPrism-HNSCC is the first implementation of the OncoPrism platform, followed by the recently launched OncoPrism-NSCLC. Development of ICI response prediction tests in other cancers are under investigation as part of the multi-site PREDAPT clinical trial.

The study, “Analytical performance of OncoPrism-HNSCC, an RNA-based assay to inform immune checkpoint inhibitor treatment decisions for recurrent/metastatic head and neck squamous cell carcinoma,” was published in BMC Cancer and was carried out in Cofactor’s CAP accredited and CLIA certified laboratory.

The analytical validation demonstrates a low level of variance of OncoPrism-HNSCC test results under conditions that reflect and even exceed day-to-day sources of variability found in laboratory settings. This low analytical variance allows for the reliable detection of biological signals above the technical noise present in analyte measurements, and was important for the development and training of the OncoPrism-HNSCC biomarker model, and ultimately the successful clinical validation of the test. Furthermore, the consistent analytical performance in the presence of potentially confounding sources of variation commonly encountered in commercial diagnostic labs gives confidence that OncoPrism-HNSCC yields robust and reliable test results in the clinical setting. Consistency and confidence is key when doctors choose which treatment to prioritize, such as chemotherapy, chemotherapy combined with immune checkpoint inhibitors, or immune checkpoint inhibitor monotherapy.

“This study demonstrates the robustness of our OncoPrism platform and will help accelerate our efforts to bring this important test to patients and help guide more precise therapy decisions for physicians,” said CEO Chris Parker.

About Cofactor:

Cofactor Genomics is a clinical-stage diagnostics company bridging the precision medicine gap by decoding RNA to solve the biggest problems in healthcare. Unlocking RNA’s use as a transformational barometer of health is accomplished through Cofactor’s PRISM database of patented Health Expression Models (HEMs). HEMs are a departure from common and often uninformative gene mutation panel tests. HEMs represent the latest advancements in machine learning and RNA that transform billions of biological RNA data points to Cofactor’s high-dimensional RNA models of biology, disease, and therapy response.

Cofactor’s pioneering work in RNA modeling has been published in The Journal of ImmunoTherapy of Cancer, The Journal of Molecular Diagnostics, and recognized by Nature Scientific Reports as breakthrough work in cancer. Cofactor is supported and partnered with 38 healthcare systems, representing 20% of US healthcare. Cofactor’s OncoPrism is CAP/CLIA-validated and Medicare-approved. Learn more from www.cofactorgenomics.com and LinkedIn.

Fonte: Business Wire