A study published this month in the Journal of Thoracic Oncology supports the usefulness of Biodesix's VeriStrat lung cancer diagnostic in monitoring the response of non-small cell lung cancer patients to tyrosine kinase inhibitor treatment targeting the epidermal growth factor receptor.
Led by scientists at Milan's San Raffaele Scientific Institute as well as Biodesix researchers, the study examined plasma samples from 111 NSCLC patients treated with the EGFR TKI gefitinib. The study confirmed previous findings that patients who tested VeriStrat "good" prior to receiving gefitinib had longer median progression-free survival and overall survival compared to patients who tested Veristrat "poor."
During the course of treatment 88 percent of patients maintained their baseline VeriStrat classification, while at the time of treatment withdrawal or disease progression 30 percent changed their classification – the majority shifting from "good" to "poor." These changes, the study authors said, were "associated with new lesions."
The company said that the results "may support the potential utility of VeriStrat in treatment monitoring, although more research is needed to support the use of VeriStrat in this setting."
Further, the researchers believe that a VeriStrat "poor" classification at baseline may be related to unknown resistance mechanisms to EGFR-TKI therapy, while a shift from VeriStrat "good" to VeriStrat "poor" over the course of treatment "may indicate a specific type of progression with the development of new cancer lesions," the company said.
VeriStrat is based on Biodesix's ProTS platform, which combines MALDI mass spectrometry with a set of algorithms to predict response to EFGR TKI therapy based on a patient's proteomic profile. The company launched the test commercially in May 2009 and offers it out of its CLIA-accredited laboratory.
Thus far, Biodesix has focused on applying VeriStrat to NSCLC, but it is investigating its usefulness in other diseases including breast, pancreatic, and liver cancer. Last month the company signed deals with Concentra, a subsidiary of managed care organization Humana, and with Hooper Holmes Health and Wellness, a provider of various medical exam and data services, in order to expand patient access to the test (GWDN 10/13/2011).