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

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Biodesix, Inc. recently announced that the GeneStrat™ blood-based panel 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-alk-egfr. 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.

Source: Biodesix