Biodesix Announces Breakthrough in Molecular Diagnostics for Lung Cancer

Biodesix, Inc. has announced the publication of positive results from a clinical study that provides additional information to oncologists treating non-small cell lung cancer (NSCLC).

In the study published in the current issue of the Journal of the National Cancer Institute, a diagnostic from Biodesix was able to separate patients into groups with statistically different prognoses when receiving second-line treatment using inhibitors to the epidermal growth factor receptor (EGFR) such as gefitinib (Iressa, AstraZeneca) and erlotinib (Tarceva, OSI/Genentech/Roche).

Biodesix's product, VeriStrat, is a simple blood test, and is the first mass spectrometry diagnostic that uses multiple markers and which has been shodwn to be clinically reproducible.

According to the American Cancer Society it is estimated that more than 213,000 new lung cancers will be diagnosed in 2007, about 80% of which will be NSCLC. The significant clinical challenge addressed by the study is the fact that EGFR-TKI drugs work well in a relatively small sub-set of NSCLC patients and have increased quality-of life in a much larger subset compared to the standard chemotherapy regimen.

However, there has not been a simple, effective method to predicatively indicate how patients may respond to these drugs. The study validates that Biodesix's proprietary methods and tools can inform the decision-making process of oncologists and ultimately improve patient outcomes and avoid ineffective and costly therapy for patients not likely to benefit from targeted drugs.

"We were pleased to have the opportunity to participate in and contribute to this ground breaking study," said David Brunel, Biodesix's Executive Chairman.

He continued, "Our near term objective is to make VeriStrat available for general use by oncologists to support their decision making process as they deal with NSCLC patients. We believe that VeriStrat can become useful in clinical decision making relative to the use of EGFR-TKI drugs for NSCLC patients and represents a significant commercial opportunity for Biodesix. Additionally, we are working on other opportunities in cancer and other degenerative diseases where the Biodesix methods and tools could contribute to improvements in patient care and treatment outcomes."

The JNCI publication, jointly authored by scientists from Biodesix, University of Colorado Health Sciences Center, Denver, and Vanderbilt-Ingram Cancer Center, Nashville, and international collaborators in Italy and Japan, describes the development, and subsequent validation on two retrospective clinical studies where the resulting analysis of mass spectrometry data resulted in a diagnostic method that may, as the authors write, "help to identify high-risk patients [that] could reduce rates of both over treatment and under treatment and improve survival for NSCLC patients."

According to Dr. Heinrich Roder, Chief Science Officer at Biodesix, "Molecular diagnostics using mass spectrometry has had some false starts in the past. At Biodesix, we have spent the last several years developing a set of tools and methods that we believe lead the field. This publication, and the strong validation it provides, is representative of what our platform can do and, as indicated in the study's conclusion demonstrates that MALDI MS can assist in the pre-treatment selection of subgroups of NSCLC patients who are likely to show improved survival after treatment with EGFR-TKIs."

Roder also pointed out, echoing the comments in an editorial by Ming Tsao and Francis Shepherd (2) in the same JNCI issue, that further validation was necessary and that the Company was actively in engaged in preparing further prospective clinical trials. Nonetheless, Tsao and Shepherd noted "this study represents an important milestone in the development of serum-based biomarkers for predicting NSCLC outcomes."