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Lung Cancer Study Evaluating Changes in VeriStrat Status over the Course of Treatment with Gefitinib Published in Journal of Thoracic Oncology

Biodesix Inc, a fully integrated molecular diagnostic company dedicated to personalizing medicine, announced today the publication of “Changes in plasma mass-spectral (VeriStrat) profile in course of treatment of NSCLC patients with EGFR-TKIs” by Lazzari, et al. in the November issue of the Journal of Thoracic Oncology, currently available online.

The study retrospectively evaluated VeriStrat classification prior to the start of treatment with gefitinib, during the course of treatment, and at progression or withdrawal from treatment. VeriStrat is a serum proteomic test that classifies non-small cell lung cancer (NSCLC) patients according to an algorithm developed in a study of NSCLC patients treated with epidermal growth factor receptor (EGFR) inhibitors, such as erlotinib (Tarceva®) or gefitinib (Iressa®). The test identifies patients who are likely to have good (VeriStrat “Good”) or poor (VeriStrat “Poor”) outcomes after treatment with EGFR tyrosine kinase inhibitors (TKIs).

Blood samples from 111 patients with advanced NSCLC treated with gefitinib underwent VeriStrat testing. The study confirmed previous data that patients who tested VeriStrat Good prior to receiving gefitinib had longer median progression free survival (PFS) and overall survival (OS) as compared to patients who tested VeriStrat Poor. While during the course of treatment most patients (88%) maintained their baseline VeriStrat classification, at the time of treatment withdrawal or disease progression 30% of patients changed their VeriStrat classification. The majority of these changes were patients shifting from VeriStrat Good to VeriStrat Poor. Changes from Good to Poor at progression were associated with the development of new lesions, while the majority of patients maintaining their baseline VeriStrat Good classification had progression identified from metastases to the brain or increase of lesion diameter by RECIST criteria. The authors conclude that this finding may support the potential utility of VeriStrat in treatment monitoring, although more research is needed to support the use of VeriStrat in this setting.

Authors also surmise that the study results suggest that a VeriStrat Poor classification at baseline may be related to unknown resistance mechanisms to EGFR-TKI therapy, while a shift from VeriStrat Good classification to VeriStrat Poor may indicate a specific type of progression with the development of new cancer lesions. Biodesix is engaging in further research to explore the longitudinal behavior of VeriStrat classification and makes VeriStrat available to researchers developing targeted therapies to further understand its potential to help physicians guide therapy and to provide additional information on patient response to therapies.

About VeriStrat

VeriStrat is a serum proteomic test for patients with advanced non-small cell lung cancer (NSCLC). The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors. Samples are processed in Biodesix’ CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1500 patients. For more information or to order VeriStrat, visit www.VeriStratSupport.com .

About Biodesix

Biodesix is a personalized medicine company focused on the development of diagnostic products that inform treatment decisions and improve patient care. The Company’s goal is to give physicians more information about the patient and their disease;understanding the clinically meaningful information contained within each patient’s molecular profile leads to better care and better outcomes. The Company’s unique approach is based on ProTS®, proprietary technology which exploits the power of mass spectrometry and enables the discovery of specific molecular profiles. Biodesix collaborates with clinical investigators to address criticalclinical questions, and partners with biotechnology and pharmaceutical companies todevelop diagnostics toselect patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.


Erik Clausen or Kena Hudson

Chempetitive Group for Biodesix



Topics: blood-based cancer test, cancer diagnostics, EGFR, Erlotinib, gefitinib, personalized medicine, Press Releases, Tarceva, Veristrat, Iressa, Journal of Thoracic Oncology, liquid biopsy, lung cancer, Non-Small Cell Lung Cancer, NSCLC, oncology