Biodesix Announces Publication of Seminal PROSE Study in THE LANCET ONCOLOGY

Study highlights VeriStrat®’s ability to predict differential treatment outcomes between erlotinib and chemotherapy for non-small cell lung cancer

Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced the publication of results from the investigator-initiated study, “Randomised Proteomic Stratified Phase III Study of Second Line Erlotinib Versus Chemotherapy in Patients with Inoperable Non-Small Cell Lung Cancer (PROSE),” in the June 2014 issue of The Lancet Oncology.

PROSE is the first successful, prospective biomarker-stratified study in thoracic oncology to test treatment and biomarker interaction. Data from the multi-center, randomized proteomic stratified study of 285 patients was first presented at the 2013 Annual Meeting of the American Society of Clinical Oncology® (ASCO®) in Chicago. The trial confirmed that the non-invasive VeriStrat® test from Biodesix is predictive of differential treatment outcomes between two standard treatment options for advanced non-small cell lung cancer (NSCLC) patients who have progressed after first-line treatments and who are EGFR wild-type (WT) or whose EGFR status is unknown: single-agent chemotherapy or the targeted drug erlotinib (Tarceva®).

“The findings from PROSE, now published in The Lancet Oncology, provide evidence that the VeriStrat serum-based diagnostic test provides physicians with clinically useful information helping to guide therapy for lung cancer patients in the second-line setting,” said the study’s principal investigator Vanesa Gregorc, M.D., of the Department of Oncology at the Scientific Institute of the University Hospital San Raffaele in Milan, Italy. “This test offers meaningful insight into which therapy, either EGFR-TKIs or chemotherapy, is likely to lead to the best survival outcome for lung cancer patients.”

Erlotinib, an EGFR-TKI, is commonly used in patients who harbor an EGFR mutation; however, only a small percentage of patients have this mutation. For those patients without a known EGFR mutation, or those whose EGFR status is unknown, VeriStrat identifies patients who can still be considered for this targeted therapy. Taking erlotinib, a daily pill, instead of chemotherapy may result in a better quality of life during advanced stages of cancer. Likewise, VeriStrat helps rule out the roughly 30 percent of patients who are highly unlikely to benefit from erlotinib and should receive chemotherapy.

Lung cancer is the most common cancer in the world, with an estimated 1.61 million new cases diagnosed per year. There is a clinical need for predictive markers that can help physicians make more-informed treatment decisions for this disease.

“VeriStrat provides oncologists with additional clinical information enabling them to improve decision making in the EGFR WT population of NSCLC, which provides more options to benefit their patients,” said David Brunel, CEO of Biodesix. “This is the first of a number of tests Biodesix will be introducing to provide clinically relevant information to physicians.”

Biodesix and VeriStrat® are registered trademarks of Biodesix, Inc. Tarceva® is a trademark of OSI Pharmaceutical, LLC, an affiliate of AstellasPharma US, and Genentech, Inc. All other trademarks are the property of their respective owners.

About Biodesix
Biodesix is a molecular diagnostics company advancing the development of innovative products for personalizing medicine. The company provides physicians with diagnostic tests for earlier disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance which may lead to improved patient outcomes. Biodesix discovers, develops and commercializes multivariate protein diagnostics based on its proprietary mass spectrometry based discovery platform, ProTS®. VeriStrat, a multivariate serum protein test, is Biodesix’ first product developed with ProTS. The commercially available test provides oncologists with information to help them select between erlotinib and single-agent chemotherapy for advanced lung cancer patients. VeriStrat has been studied in over 80 clinical trials and ordered for over 5000 patients. Tests are processed in Biodesix’ CLIA-certified laboratory and results are reported in less than 72 hours. In addition to developing novel diagnostics independently, the company also partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve utility of therapeutic agents.

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