Biodesix to Present Data from Three Studies Indicating the Utility of Blood-Based Diagnostic Tests at AACR Annual Meeting

Three separate studies in patients with advanced stages of cancer investigate how blood tests can be used to select patients for therapy will be presented by Biodesix’ scientists and their collaborators at the AACR Annual Meeting in New Orleans.

One study, presented in collaboration with Dr. Jeffrey Weber at NYU Langone Medical Center, indicates the clinical utility of a proteomic-based blood test in patients with melanoma treated with immunotherapy. In addition, two studies will be presented about the clinical utility of a blood-based targeted mutation test for EGFR, KRAS and BRAF as well as the detection of EML4-ALK fusions.

The predictive and prognostic utility of blood-based diagnostic testing for patients with solid tumors is gaining acceptance in clinical practice. Biodesix’ blood tests are minimally invasive, highly sensitive and offer fast turnaround time to results, enabling clinicians to make treatment decisions sooner.

Poster title: A mass spectrometry-based serum test to predict outcome of treatment with nivolumab: Analysis of samples taken during therapy

Authors: Jeffrey Weber¹, Heinrich Roder², Senait Asmellash², Krista Meyer², Kevin Sayers², Arni Steingrimsson², Joanna Roder².

¹NYU Langone Medical Center, New York, NY; ²Biodesix, Boulder, CO

Abstract: The durability of antitumor responses observed in patients treated with antibodies blocking PD-1 supports a central role for these drugs in current melanoma therapy. However, not all patients achieve a durable response, so identification of biomarkers able to aid therapeutic decision making is needed. We have recently reported on a mass-spectrometry-based test (BDX008) able to stratify patients according to outcome following anti-PD1 therapy using pretreatment serum samples. The test assigns a binary label of “Positive” or “Negative”, denoting the likelihood of good or poor outcome, respectively, following anti-PD 1 therapy. Here we present the results of an investigation of the use of this test with samples taken during administration of immunotherapy.

This poster will be presented on Wednesday, Apr 20, 2016, 7:30 AM -11:00 PM, Section 23, Poster Board #2

Oral Presentation title: Diagnostic test system for sensitive, specific and reproducible detection of EML4-ALK RNA fusion transcripts in the blood of patients with NSCLC

Authors: Hestia Mellert, PhD¹, Leisa Jackson¹, Dianna Maar, PhD², PhD, Dawne Shelton, PhD², and Gary A Pestano, PhD¹

¹Biodesix Inc. Boulder CO 80301; ²BioRad Digital Biology Center, Pleasanton, CA 94588

Abstract summary: Clinical testing methods for the detection of RNA fusion transcipts in tissue currently include FISH, IHC, PCR and NGS. However, approximately 30% of patients with advanced non-small cell lung cancer (NSCLC) are not candidates for tissue biopsies and in cases where tissue is obtained, it is not always of sufficient quantity for molecular testing. For these reasons, the detection of nucleic acids in circulation has become increasingly relevant to clinical testing. In this study, we focused on the development of an EML4-ALK diagnostic test system that includes the prospective collection of whole blood and the reproducible detection of mRNA fusion transcripts by a Droplet Digital^TM PCR-based technology.

This oral presentation will be made on Sunday, Apr 17, 2016, 5:20 PM - 5:35 PM, Room 391, Morial Convention Center.

Poster title: Blood-based Profiling of Patients with NSCLC using CLIA-certified cell-free DNA Tests for EGFR, KRAS and BRAF Point Mutations and Test Use in Clinical Practice

Authors: Hestia Mellert, PhD, Scott Thurston, Trudi Foreman, Westen Hahn, Nicholas Dupuis, PhD, Gary Pestano, PhD

Biodesix Inc. Boulder CO 80301

Abstract summary: Nearly 80% of patients will not have mutation results available at their initial oncology consult and as many as 1 in 4 patients will begin treatment in advance of receiving their tumor mutation results. These factors hinder diagnosis at the molecular level, which is an important component in the decision to commence treatment with specific targeted therapies. The goal of this study was to measure the utility of a CLIA-certified Laboratory Developed Test (LDT) in the absence of a tissue diagnosis.

This poster will be presented on Sunday, Apr 17, 2016, 1:00 PM - 5:00 PM, Section 23

The AACR Annual Meeting includes speakers, hundreds of invited talks, and more than 6,000 proffered papers from researchers around the world. Over 18,000 people are expected to attend the meeting in 2016.

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

About Biodesix
Biodesix® is a molecular diagnostics company advancing the development of innovative blood-based tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic blood tests, including GeneStrat™ and VeriStrat®, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of precision medicine, Biodesix is developing new blood tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.  Detailed information about the company is available at www.biodesix.com.