Biodesix Acquires Integrated Diagnostics, Expanding Lung Disease Franchise

July 9, 2018
Biodesix Acquires Integrated Diagnostics, Expanding Lung Disease Franchise
Biodesix has expanded its lung disease test franchise by acquiring Intagrated Diagnostics (Indi), whose test portfolio includes its lead oncology product XL2, a liquid biopsy test designed to offer a noninvasive means of ruling out lung cancer (pictured) for patients with suspicious lung nodules. [Memorial Sloan Kettering Cancer Center]

Biodesix said today it has acquired Integrated Diagnostics (Indi) for an undisclosed price, in a deal that will expand the buyer’s franchise in molecular tests for lung disease.

Based in Seattle, Indi was established in 2009 by co-founders who included systems biology pioneer Leroy (Lee) Hood, M.D., Ph.D. The company exclusively licensed foundational intellectual property from the California Institute of Technology (Caltech) and the Institute for Systems Biology and Caltech, where Dr. Hood is chief strategy officer, a co-founder and a professor.

Indi’s test portfolio includes its lead oncology product XL2, a liquid biopsy test whose name is short for Xpresys Lung 2, as in a second-generation version of the acquired company’s Xpresys Lung diagnostic. XL2 is designed to offer a noninvasive means of ruling out cancer for patients with suspicious lung nodules.

XL2 is a pulmonary nodule classifier intended to identify lung nodules that have a high probability of being benign by measuring blood proteins. Indi has cited data from the PANOPTIC or PulmonAry NOdule Plasma proTeomIc Classifier trial (NCT01752114) showing that in a subset of patients with low-to-moderate risk lung nodules, XL2 was 98% effective at distinguishing benign nodules from those that were malignant.

The subset—178 of the trial’s total 685 enrolled patients with 8- to 30-mm lung nodules— had a 16% prevalence of lung cancer. XL2 demonstrated a sensitivity of 97%, a specificity of 44%, and a negative predictive value (NPV) of 98% in distinguishing benign from malignant nodules.

“If the integrated classifier results were used to direct care, 40% fewer procedures would be performed on benign nodules, and 3% of malignant nodules would be misclassified,” Gerard A. Silvestri, M.D., of Medical University of South Carolina, and colleagues, reported in the study, published February 26 in the journal Chest.

Indi CEO Al Luderer said in a statement that his company had actively explored how best to bring XL2 to market since the test was validated last year.

“Indi and Biodesix share important values and technologic synergies that make us ideal partners, including a singular focus on providing high-value, blood-based diagnostic products for lung disease and the expert application of advanced mass spectrometry and informatics,” Luderer stated. “Additionally, we are impressed by Biodesix’s rapidly expanding commercial presence and extensive lung disease product pipeline.”

Added Biodesix CEO David Brunel: “The team at Indi has developed and substantially validated an important test that helps physicians better manage patients who present with a suspicious nodule in their lung,”

Scott Hutton, chief operating officer of Biodesix, said XLS will complement Biodesix’s existing commercial blood-based lung cancer tests, which have been created to deliver results within 72 hours.

These tests include the Biodesix VeriStrat® a proteomic test for lung cancer that is designed to provide objective prognostic information independent of treatment choice, including immunotherapy; and the GeneStrat® genomic test, which measures actionable mutations for non-small cell lung cancer, with the goal of further informing therapeutic decisions and monitoring.