Source: www.rockyradar.com
Author: staff

“One data point doesn’t tell you very much in most cases,” comments David Brunel, CEO of Biodesix, a medical diagnostics company based in Broomfield, Colorado. This principle guides Biodesix’s approach to developing diagnostics which aim to indentify a patient’s expected response to a particular therapeutic. Biodesix’s technology evaluates multiple biomarkers – identified with a blood sample and analyzed using mass spectrometry – to predict response rather than trying to make a determination based on a single biomarker.

VeriStrat® is the company’s first test, categorizing the expected prognosis of patients with non-small cell lung cancer (NSCLC) who receive treatment with a class of targeted cancer drugs know as epidermal growth factor receptor inhibitors or EGFR-Is. Tarceva (erlotinib) is an EGFR-I commonly used to treat NSCLC patients. VeriStrat classifies patients as either VeriStrat Good or VeriStrat Poor and this information can assist a physician’s decision to pursue treatment with Tarceva or another treatment.

To complete a VeriStrat test, a patient’s blood is drawn and sent to the Biodesix lab in Aurora, Colorado. There the sample is run through a mass spectrometer and the data generated from the mass spectrometer is then processed through a proprietary software algorithm to determine a patient’s VeriStrat classification. The algorithm was developed using samples and subsequent disease response data from patients who had received treatment with an EGFR-I. According to Brunel, “several markers were identified in the group of patients whose cancer is prone to respond to EGFR-I treatment versus those whose cancer is unlikely to respond.” The ability of VeriStrat to identify those NSCLC patients who are likely to survive significantly longer on EGFR-I therapy has been validated in several independent sample sets. In addition, VeriStrat has not shown the ability to separate NSCLC who receive non-EGFR-I treatments such as chemotherapy with statistical significance. And VeriStrat classification is not meaningfully correlated with other factors that might influence survival time such as age, sex, and history of smoking.

The VeriStrat test was launched in May and Biodesix continues to pursue a variety of commercialization activities. The company recently rounded out its management team by adding several industry veterans. Biodesix is currently conducting a prospective randomized clinical trial to enhance the data supporting VeriStrat’s clinical use and targeting opinion leading physicians to gain their support. Biodesix is also working to gain reimbursement for the test from private payers and Medicare. While the cost of VeriStrat is in the thousands of dollars (on par with other personalized medicine diagnostics), Brunel believes the company has focused its efforts in such a way to justify this cost: “It’s hard to make an early-stage diagnostic where you’re screening everyone. But for VeriStrat we are much more selective.” Patients with NSCLC are very sick necessitating efforts to make the best possible treatment choice, and the all the treatment options cost thousands of dollars per month.

While Biodesix remains focused on the commercial success of VeriStrat within NSCLC, Brunel notes many opportunities for expansion as time and resources permit. The company presented data at ASCO (the largest conference for oncologists) related to the use of VeriStrat to identify patients likely for treatment success with Tarceva in head and neck cancer. VeriStrat is also expected to have utility in identifying patient response to EGFR inhibitors other than Tarceva including Erbitux (cetuximab) and Vectibix (panitumumab), which are both used in the treatment of colorectal cancer. Biodesix’s approach of combining mass spectrometry with algorithmic analysis, driven by the scientific efforts of theoretical physicist and CTO Heinrich Röder, will also likely prove effective in identifying response to other types of targeted chemotherapeutics as well as having potential in other conditions including rheumatoid arthritis. Brunel also believes opportunities exist to partner with therapeutic companies to develop companion diagnostics for drugs currently in development.

Biodesix recently brought in a round of financing and has money committed for another round in 2010. Brunel believes this capital gives the company time to ramp its commercial operations and allow runway for it to generate cash flow from VeriStrat. While it is easy to think of newer personalized medicine companies simply as the next type of diagnostic companies, Brunel notes the significant differences in the new breed: “a complex technology, significant risk, and comprehensive clinical trials.” As such, Brunel expects that as Biodesix matures it will “look more like a specialty pharma company than a diagnostics company.”