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Biodesix Announces Phase 3 Clinical Trial Collaboration with Kadmon

Biodesix Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, today announced a collaboration with Kadmon Corporation, LLC, to explore the utility of Biodesix’ VeriStrat® test in a Phase 3 non-small cell lung cancer (NSCLC) study of Kadmon’s KD019, a reversible tyrosine kinase inhibitor (TKI) targeting EGFR, HER2, VEGFR2 & 3, and SRC.

The Phase 3 study is designed to evaluate KD019 compared to erlotinib in patients with stage IIIB/IV NSCLC who have progressed after first- or second-line chemotherapy.  It incorporates an exploratory analysis using VeriStrat, a commercially available, blood-based test that is currently used to help physicians guide treatment for patients with non-small cell lung cancer. VeriStrat testing will be performed on serum samples from the study to assess the test’s utility in identifying patients with better or worse outcomes following treatment with KD019.  As a multiple TKI with superior potency against wild-type EGFR, KD019 is designed to improve overall survival compared to erlotinib.

“We are very pleased to work with Kadmon on this program” commented Paul Beresford, Ph.D., Biodesix’ Vice President of Business Development and Strategic Marketing.  “Our successful collaboration may bring a personalized approach to this exciting new therapy.”  Over the past year Biodesix has forged multiple partnerships with bio-pharmaceutical companies to examine VeriStrat’s utility with innovative oncology therapies and to discover novel diagnostic tests.

John Ryan, Ph.D., M.D., Chief Medical Officer of Kadmon said, “This collaboration is aligned with our strategic vision to advance leading-edge science and therapies targeting multiple pathways of proliferation and survival in disease.”

For more information about the Phase 3 study of KD019, visit www.clinicaltrials.gov.

About VeriStrat

VeriStrat is a serum proteomic test that helps physicians guide treatment decisions 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 certified laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 2500 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 critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.

Topics: bio-pharmaceutical, blood-based cancer test, cancer diagnostics, EGFR, Erlotinib, personalized medicine, Press Releases, SRC, VEGFR2, Veristrat, HER2, Kadmon, Kadmon Corporation, KD019, liquid biopsy, LLC, lung cancer, molecular diagnostic, Non-Small Cell Lung Cancer, NSCLC, oncology, Phase 3 Clinical Trial