US-based Biodesix has secured CE Mark approval for its VeriStrat specimen collection and shipping kit, a blood-based protein diagnostic that predicts differential treatment outcomes for non-small cell lung cancer (NSCLC).
The non-invasive serum proteomic test is designed for patients with advanced NSCLC.
It identifies patients that are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRs).
VeriStrat predicts differential treatment outcomes between two types of therapies for second-line treatment of non-operable, advanced NSCLC: chemotherapy or the targeted drug erlotinib (Tarceva).
The VeriStrat test along with other clinical factors can help physician decide the treatment ithat s right for their non-small cell lung cancer patients.
According to World Cancer Research Fund International, lung cancer is the most common cancer globally, with an estimated 1.61 million new cases diagnosed annually.
Epidermal growth factor receptor inhibitors are used to treat advanced lung cancer patients for almost a decade. Currently, erlotinib, an EGFR inhibitor, is commonly used in NSCLC patients who harbour an EGFR mutation.
However, for the majority of NSCLC patients who do not have this mutation or whose mutation status is unknown, there is a vital clinical need for predicative markers that can help physicians make more-informed treatment decisions.
VeriStrat provides oncologists with information to help them select between erlotinib (Tarceva) and single-agent chemotherapy for advanced NSCLC patients.
Dr Vanesa Gregorc of the Department of Oncology at the Scientific Institute of the University Hospital San Raffaele in Milan, Italy, presented results of an independent Phase III clinical trial for the VeriStrat test at the 2013 American Society of Clinical Oncology (ASCO) annual meeting in June 2013.
The multi-centre, randomised proteomic stratified study (known as PROSE) is the first completed prospective biomarker-stratified validation study in oncology.
The study of 285 patients confirmed that VeriStrat status is prognostic and specifically predictive of differential overall survival benefit for erlotinib versus chemotherapy in the second-line setting.
Dr Gregorc said: "PROSE demonstrated that VeriStrat is a predicative test that can provide physicians with clinically useful information about their patients and which treatment will provide the best overall survival."
The study results showed no significant difference between patients classified as ‘VeriStrat Good’ and ‘VeriStrat Poor’.
The patients whose test results classified them as ‘VeriStrat Poor’ had better survival outcomes on chemotherapy versus erlotinib, while patients who were classified as ‘VeriStrat Good’ had similar survival outcomes when treated with erlotinib or chemotherapy.
Biodesix CEO David Brunel said making VeriStrat results available to physicians for patients in the European Union has been an important goal for Biodesix.
"With the CE Mark for the specimen collection and shipping kit, more physicians can incorporate this valuable new component into the set of tools they need to guide therapy," Brunel said.
"VeriStrat will allow them to make targeted, timely treatment decisions that can improve survival outcomes and potentially provide a higher quality of life."
Image: A squamous cell carcinoma. Photo: courtesy of Nephron.