In the study, VeriStrat was used to classify outcomes in patients with SCCHN who were treated with gefitinib (G), erlotinib and bevacizumab (E/B), cetuximab (C), or palliative chemotherapy (PC). Gefitinib, erlotinib and cetuximab are EGFRIs with activity in SCCHN. Results from the study show that among patients treated with EGFRIs, VeriStrat predicted an overall survival benefit (G: p=0.007, HR 0.41; E/B: p=0.02, HR 0.20; C: p=0.06, HR-0.26). VeriStrat did not classify survival outcomes in patients treated with palliative chemotherapy (PC: p=0.76, HR 0.88).

At present, there are no validated diagnostic tests to guide therapy selection for patients with SCCHN. Having a blood test that provides results which will help oncologists decide whether or not to treat head and neck cancer patients with anti-EGFR agents would be a major advancement in the treatment of this disease, stated Ezra Cohen, MD, Associate Professor of Medicine at the University of Chicago and a study investigator.

The data support previous study results in which VeriStrat effectively identified patients with NSCLC who were likely to have good or poor outcomes following treatment with EGFRIs (J Natl Cancer Inst. 2007;99(11):838-46). Additional studies are underway to further validate the test and to explore the clinical utility of VeriStrat in other solid epithelial tumors and with other EGFRIs.

A study reporting results evaluating the association of VeriStrat status and genetic features with survival after treatment with erlotinib in patients with NSCLC will also be presented on Saturday, May 30th.

The data to be presented at ASCO validate our molecular profiling approach to identify patient populations who are most likely to benefit from targeted therapies as well as those who are unlikely to receive any benefit, said Heinrich Roder, D.Phil., Chief Technical Officer at Biodesix. Biodesix is committed to advancing personalized medicine as we continue our research in identifying the relationship between disease, mass spectrometry profiles and therapies. The data from ASCO, coupled with our previous research, show that VeriStrat is effective at predicting outcomes to therapeutics affecting the EGFR pathway, independent of their specific mode of action, and for tumor types where this is a targeted pathway. This brings us one step closer to a healthcare model that is highly personalized.