Biodesix’ GeneStrat Blood-Based Mutation Test Now Includes EML4-ALK Fusions

EGFR sensitizing, EGFR T790M, EML4-ALK, KRAS, and BRAF; 72 hour Turnaround Time to Results

January 7, 2016….Biodesix, Inc. today announced that the GeneStrat™ blood-based test now includes EML4-ALK fusions in addition to EGFR sensitizing, EGFR T790M, KRAS, and BRAF mutations. GeneStrat is a non-invasive, blood-based test analyzing circulating tumor DNA and RNA, designed to provide fast, accurate results in 72 hours for newly diagnosed non-small cell lung cancer (NSCLC) patients.

GeneStrat blood-based mutation testing offers significant advantages for patients and their treating physicians over standard tissue testing, which can delay treatment and increase patient risk due to complications from an invasive biopsy. With the arrival of GeneStrat results within 72 hours, physicians can support critical treatment decisions as early as initial diagnosis, and can expedite appropriate treatment for patients.

Based on NSCLC patient samples, GeneStrat is highly sensitive and specific, with proven concordance data with tissue, FISH and PCR based methods:

• EML4-ALK fusions showed 85% clinical sensitivity and 92% concordance.
• EGFR sensitizing mutations showed 95.8% clinical sensitivity and 98.8% concordance.
• EGFR T790M resistance mutation showed 86.7% clinical sensitivity with 96.4% concordance.

Ongoing concordance studies with additional clinical samples for the actionable mutations are summarized at www.biodesix.com/genestrat.  Clinical specificity for all testing is 100%.

Biodesix^® develops blood-based NSCLC mutation testing to address the clinical need for quick, non-invasive results that determine real-time molecular status while minimizing risk and costs to patients, as well as enabling informed treatment decisions soon after diagnosis. Standard tissue testing requires a surgical biopsy, which may put patients at higher risk. Blood-based testing upon disease progression offers “real-time” information, without requiring surgical re-biopsy. Blood testing can also capture mutation information regardless of tumor location or heterogeneity, where tissue testing may miss relevant molecular alterations.  The mean cost of each tissue biopsy is $14,634, with costs up to four times higher for the 19.3% of patients that experience biopsy complications¹. Also, biopsy sample availability is often limited, and awaiting tumor biomarker results may delay treatment decisions and ultimately impact patient outcomes.  Based on recent studies, one in four patients begin cancer treatment before receiving results².

GeneStrat can be reflexed to VeriStrat^®, a blood-based proteomic test (for EGFR negative patients) used to identify more aggressive tumor growth and inform likely patient benefit from treatment.  VeriStrat and the mutations in GeneStrat are covered by Medicare and many private payers.

Biodesix, VeriStrat and GeneStrat are trademarks or registered trademarks of Biodesix, Inc.  All other trademarks referenced herein are property of their respective owners.

About Biodesix
Biodesix^® is a molecular diagnostics company advancing the development of innovative blood-based tests – GeneStrat™ and VeriStrat^® - in oncology for precision medicine. The company provides physicians with diagnostic tests for earlier disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance, which can lead to improved patient outcomes. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic tests on various discovery platforms. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve utility of therapeutic agents.

For more information about Biodesix, please visit www.Biodesix.com.

1. American Society for Radiation Oncology (ASTRO), 2014. Medicare costs analysis indicates need for decreasing use of biopsies as diagnosis tool for lung cancer. (Link no longer available.)
2. Lim C, Tsao MS et al. Ann Oncol. 2015 [Epub ahead of print]