Pretreatment serum samples from 114 patients treated with bevacizumab plus erlotinib were classified as either VeriStrat Good or VeriStrat Poor.  The study showed there was a statistically significant difference in overall survival between the two groups.  Patients classified as VeriStrat Good had a median overall survival of 13.4 months versus 6.2 months for patients classified as VeriStrat Poor (p=0.0027, HR=0.480, 95%CI:0.294-0.784).  Median progression free survival for patients classified as VeriStrat Good was 4.0 months and 3.2 month for patients classified as VeriStrat Poor, but this difference was not statistically significant (p=0.2632, HR=0.768, 95% CI: 0.482-1.223).

Researchers concluded that the VeriStrat test may be useful for clinical decision-making, representing a prognostic and potentially predictive biomarker for treatment with erlotinib and erlotinib combinations.  Prospective trials are ongoing, including a Phase III trial in advanced squamous cell lung cancer, sponsored by the European Thoracic Oncology Platform (ETOP). 

“These data represent the third study in which we have shown that VeriStrat classification correlates with survival outcomes in lung cancer patients treated with bevacizumab plus erlotinib, “ commented David Brunel, CEO of Biodesix. “Although additional data is needed, this study supports the view that VeriStrat may be useful in identifying lung cancer patients that could benefit from the combination of bevacizumab and erlotinib, which is regarded as less toxic than traditional chemotherapy.”

About VeriStrat:  VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC.  The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs).  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 1500 patients.  For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.

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.

This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.

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.

European patent number 2,247,954 is the counterpart to U.S. patent number 7,867,775 and covers the use of VeriStrat for selection of head and neck cancer patients for treatment with targeted drugs. U. S. patent number 8,024,282 (‘282) provides additional intellectual property protection for the methods used with VeriStrat which are also related to Biodesix’ underlying core ProTS® technology.  Specifically, the ‘282 patent supports the Company’s methods for the reliable and reproducible classification of samples in clinical diagnostics using computer systems configured as probabilistic classifiers.  Related U.S. patent 7,906,342 covers Biodesix’ methods for using mass spectrometry of patient samples to monitor cancer patients being treated with drugs targeting the epidermal growth factor receptor (EGFR) pathway for response or non-responsiveness to the treatment.  Biodesix also received notice from the PTO that two additional patent applications covering the use of VeriStrat for monitoring of head and neck, as well as colorectal cancer patients being treated with drugs targeting the EGFR pathway have been allowed; these patents are expected to issue early in the first quarter of 2012.

Drug therapies targeting the EGFR pathway and related molecular targets play an increasingly important role in cancer therapy.  Identifying patients likely to benefit from this class of drugs is key to improving overall patient outcomes.

“The expansion of our patent estate is an integral part of our global strategy to protect VeriStrat and our technology platform,” commented David Brunel, Biodesix CEO.  “This protection strengthens our commercial position as a leading provider of diagnostics to personalize medicine for oncology patients.”

About Biodesix

Biodesix is a fully integrated molecular diagnostics company advancing the development of products for personalized medicine. Biodesix provides physicians with tools for earlier disease detection, more accurate diagnosis, and better therapeutic guidance. In 2009, Biodesix launched VeriStrat®, a serum proteomic test that helps physicians guide treatment for patients with non-small cell lung cancer. VeriStrat is based on ProTS®, proprietary technology which harnesses the power of mass spectrometry and enables the discovery of specific molecular profiles that characterize a patient’s condition or likely outcome in response to therapy.  The ProTS® platform has broad application and provides the foundation for collaborations with leading researchers as well as partnerships with biotechnology and pharmaceutical companies seeking to develop companion diagnostics and improve the targeting of their therapies. For more information about Biodesix, please visit the Company’s website at www.Biodesix.com.

Media Contacts:

Erik Clausen or Kena Hudson

Chempetitive Group for Biodesix

biodesix@chempetitive.com

(510) 908-0966

This study found that choosing second-line therapy on the basis of a protein-expression test modestly improved survival in patients with advanced non-small cell lung cancer (NSCLC). The four- to six-week survival advantage held up in a sensitivity analysis involving 10,000 simulations. Choosing second-line therapy on the basis of a protein-expression test modestly improved survival in patients with advanced non-small cell lung cancer (NSCLC), computer modeling suggested.

Use of the test to decide whether to give a patient an epidermal growth factor receptor (EGFR) inhibitor led to a predicted survival of 10 months versus eight to nine months with three conventional decision-making strategies.  Read more at MedPage Today.

VeriStrat is a serum proteomic test currently used to identify NSCLC patients who are likely to respond well, or poorly, to treatment using EGFR inhibitors. The Phase III Tykerb trial (designated EGF30008), was the first to evaluate VeriStat in breast cancer and also the first to assess the assay with an endocrine agent, Biodesix notes.

Read more at Genetic Engineering News.

Pretreatment serum samples from 1041 of the 1286 patients enrolled in the EGF30008 study (81%) were classified as either VeriStrat Good or VeriStrat Poor.   In the Femara treatment arm,  patients who tested VeriStrat Good had a median progression free survival (PFS) of 10.8 months versus patients who tested VeriStrat Poor with 2.8 months (log rank p<0.0001, HR: 0.36).  The evaluation of the Femara plus Tykerb arm showed that patients who tested VeriStrat Good  had a median PFS of 11.4 months versus patients who tested VeriStrat Poor with 11.0 months (log rank p=0.53).  Multivariate analysis demonstrated a significant interaction between VeriStrat classification and treatment (interaction p=0.002), indicating that the VeriStrat test was predictive of a differential treatment effect between VeriStrat groups.  While in the Her2 positive population both VeriStrat groups benefitted from the addition of Tykerb to Femara, interestingly in the Her2 negative population  there was also a trend to a meaningful increase in PFS for patients who tested VeriStrat Poor (3.1 months vs. 11.0 months, p=0.068).

David Brunel, CEO of Biodesix commented, “We have a growing body of evidence regarding  the utility of VeriStrat in multiple tumor types, but EGF30008 represents the first study to evaluate our diagnostic test in breast cancer and the first with an endocrine agent. It’s encouraging to see that our test not only identifies a group of hormone receptor positive patients with poor outcomes on endocrine therapy,  but also has predictive power, showing that this group of patients can achieve similar outcomes to other patients when Tykerb is added to the treatment regimen, regardless of their Her2 status.”

About VeriStrat: VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC.  The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs).  Samples are processed in Biodesix’ CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment.  VeriStrat has been validated in clinical studies with over 1500 patients.  For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.

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.

Femara^® is a registered trademark of Novartis International AG.
Tykerb^® is a registered trademark of the GlaxoSmithKline group of companies in the United States and the countries outside of Europe.
This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.

The Product Differentiation Excellence Award is a prestigious recognition of Biodesix’ accomplishments in the cancer diagnostics industry, and of their first product, VeriStrat®. VeriStrat is a serum proteomic test currently available to help physicians guide therapy for patients with advanced lung cancer. Frost & Sullivan’s market research and analysis identified a critical need in lung cancer patient management for additional diagnostic information that enables better treatment decisions, particularly after initial therapy has failed. Frost & Sullivan analysts conclude that VeriStrat addresses this market need and state that “Biodesix’ VeriStrat test is changing the approach to the current paradigm of mutation-driven cancer diagnostics and measures instead an integrated effect of the host/tumor with respect to different drugs and drug combinations.” In the Best Practices report, analyst Winny Tan further notes that “Biodesix raises the bar in personalized medicine diagnostics by investing significantly in validation, clinical research, and basic R&D. The company is a best-in-practice diagnostic test developer for an industry that lacks clinically validated biomarkers through a commitment to improving patient outcomes.”

“We are honored to receive this award from Frost & Sullivan,” commented David Brunel, Biodesix’ Chief Executive Officer. “We are proud that our hard work to bring products for personalized medicine to physicians and patients has been recognized.”

In evaluating companies for the award, Frost & Sullivan considered key industry challenges that should be addressed by a differentiated diagnostic test, and benchmarked Biodesix’ performance against competitors across five key metrics: Unique Features/Functionality; Quality/Complexity; Customization; Match to Target Market Needs; and Brand Perception of the Uniqueness of the Product. Biodesix was selected as the leader in the cancer diagnostics category after garnering top marks in the Frost & Sullivan customized Decision Support Matrix, an analytical tool that compares companies’ performance relative to each other with an integration of quantitative and qualitative metrics.

About VeriStrat
VeriStrat is a serum proteomic test 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 accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1500 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.

VeriStrat, a blood-based proteomic test, is currently used by physicians to help them guide treatment for patients with previously treated advanced non-small cell lung cancer (NSCLC). The test identifies patients who are likely to have good or poor survival outcomes following treatment with EGFR-TKIs, such as Tarceva®. VeriStrat has been evaluated in several lung cancer trials, including the phase III registrational trial of Tarceva in advanced NSCLC.

The data will be presented during General Session 1 at the SABCS in San Antonio, TX on Wednesday, December 7th, 2011 at 10:15 AM CST. For more information on the location of the presentation, visit www.sabcs.org.

About VeriStrat

VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC. The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs). Samples are processed in Biodesix’ CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1500 patients. For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.

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.

Femara® is a registered trademark of Novartis International AG. Tykerb® is a registered trademark of the GlaxoSmithKline group of companies in the United States and the countries outside of Europe. Tarceva® is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas Pharma Global Development Inc. group of companies.

This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.

The study retrospectively evaluated VeriStrat classification prior to the start of treatment with gefitinib, during the course of treatment, and at progression or withdrawal from treatment. VeriStrat is a serum proteomic test that classifies non-small cell lung cancer (NSCLC) patients according to an algorithm developed in a study of NSCLC patients treated with epidermal growth factor receptor (EGFR) inhibitors, such as erlotinib (Tarceva®) or gefitinib (Iressa®). The test identifies patients who are likely to have good (VeriStrat “Good”) or poor (VeriStrat “Poor”) outcomes after treatment with EGFR tyrosine kinase inhibitors (TKIs).

Blood samples from 111 patients with advanced NSCLC treated with gefitinib underwent VeriStrat testing. The study confirmed previous data that patients who tested VeriStrat Good prior to receiving gefitinib had longer median progression free survival (PFS) and overall survival (OS) as compared to patients who tested VeriStrat Poor. While during the course of treatment most patients (88%) maintained their baseline VeriStrat classification, at the time of treatment withdrawal or disease progression 30% of patients changed their VeriStrat classification. The majority of these changes were patients shifting from VeriStrat Good to VeriStrat Poor. Changes from Good to Poor at progression were associated with the development of new lesions, while the majority of patients maintaining their baseline VeriStrat Good classification had progression identified from metastases to the brain or increase of lesion diameter by RECIST criteria. The authors conclude that this finding may support the potential utility of VeriStrat in treatment monitoring, although more research is needed to support the use of VeriStrat in this setting.

Authors also surmise that the study results suggest that a VeriStrat Poor classification at baseline may be related to unknown resistance mechanisms to EGFR-TKI therapy, while a shift from VeriStrat Good classification to VeriStrat Poor may indicate a specific type of progression with the development of new cancer lesions. Biodesix is engaging in further research to explore the longitudinal behavior of VeriStrat classification and makes VeriStrat available to researchers developing targeted therapies to further understand its potential to help physicians guide therapy and to provide additional information on patient response to therapies.

About VeriStrat

VeriStrat is a serum proteomic test 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 accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1500 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 criticalclinical questions, and partners with biotechnology and pharmaceutical companies todevelop diagnostics toselect patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.

MEDIA CONTACT:

Erik Clausen or Kena Hudson

Chempetitive Group for Biodesix

Biodesix@Chempetitive.com

510-908-0966