Biodesix (Steamboat Springs, Colorado), which is focused on developing products in personalized medicine, reported the publication of positive results from a clinical study that it said provides “additional information” to oncologists treating patients with non-small-cell lung cancer.

The company said that the study, published in the Journal of the National Cancer Institute, demonstrated that its VeriStrat blood test was able to separate patients into groups with statistically different prognoses when receiving second-line treatments for such cancer. Those treatments use inhibitors to the epidermal growth factor receptor (EGFR), such as gefitinib (Iressa), made by AstraZeneca (London, UK) and erlotinib (Tarceva), made by OSI Pharmaceuticals (Melville, New York).

The company said that the research on its test was done because such drugs “work well in a relatively small subset” of NSCLC patients; however, there has been no easy way to determine which NSCLC patients will respond to the drugs positively.

What is “impressive” about what Biodesix’s test have shown is that “we were able to do these tests at different institutions with different operators, different machines, and get almost the exact same results,” Biodesix executive chairman David Brunel told Medical Device Daily. The test has been in development about three years, he added.

Reproducibility of results is “a really key piece about what we’re doing that has emerged, I think, from the clinical data,” he said.

The company’s “near-term objective” is to “make VeriStrat available for general use by oncologists to support their decision-making process as they deal with NSLC patients,” Brunel said. Rather than seeking FDA clearance, the company will offer the test under CLIA guidelines, Brunel told MDD. CLIA guidelines fall under Centers for Medicare and Medicaid Services regulations.

The blood test gives a positive or negative result, indicating whether a patient is likely to respond to the EGFR drugs, i.e., essentially stratifying patients as to those who would likely benefit from such drugs.

Brunel said that “people who get a VeriStrat plus on our test seem to have longer survival than people with a VeriStrat minus.”

The company is using “comparative mass spectrometry.” While in the past Biodesix has focused on using tissue with mass spectrometry, the VeriStrat relies on blood samples.

According to the study abstract, as with many drugs, some NSCLC patients respond to treatment with EGFR TKIs, while others do not. For the study, serum was collected from patients prior to their being treated with gefitinib or erlotinib. The serum was analyzed using matrix-assisted laser desorption ionization (MALDI) mass spectrometry.

The abstract states that “an algorithm to predict outcomes after treatment with EGFR TKIs was developed from a training set of 139 patients from three cohorts.” The algorithm then underwent further testing, and the “clinical outcomes of survival and time to progression were analyzed.”

According to Dr. Heinrich Roder, chief scientific 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.”

The company said that further validation of its VeriStrat test is necessary and that it is planning “further prospective trials.”

Biodesix said that the American Cancer Society (Atlanta) estimates that more than 213,000 new lung cancers will be diagnosed in 2007, and about 80% of those cases will be NSCLC.

Biodesix was founded in 2005 by what it describes as several former senior pharmaceutical executives and “key scientists.”

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