This story originally ran on July 22.
Diagnostics firm Biosystems International announced this week that it has closed a €2.1 million ($2.7 million) funding round to support the commercialization of a protein biomarker-based lung cancer test.
The company will be using the funds to develop and test a prototype of the diagnostic, which will be based on protein biomarkers discovered using its high-throughput monoclonal antibody microarray platform, and take it to market sometime in 2011, Laszlo Takacs, BSI's founder and chief scientific officer, told ProteoMonitor.
The blood-based protein biomarkers to be used in the diagnostic have shown a sensitivity and specificity of over 80 percent in testing on clinical cohorts totaling over 700 cancer patients and controls, the company said in a statement.
In addition to being developed as a companion diagnostic for lung cancer, the biomarker panel could potentially be used in screening for the disease, Takacs said.
"The diagnostic application is to speed up the diagnosis of patients who are already suspected to have lung cancer due to nodules in the lung. For this application we are confident that the specificity and sensitivity of the test will add a lot of value to the results of imaging alone. We are beginning large scale clinical studies to evaluate the performance of the test in the context of lung cancer screening application," he said.
BSI is seeking to partner with a reference laboratory to offer the test as a service initially, and will be seeking-both a CE mark and FDA clearance for a kit version of the test, he added.
"Both for CE marking and FDA approval you need to have independent confirmation of our results. We are in the process of developing our prototypes and then we have to test them and move forward," Takacs said. "We will perform several independent trials. Altogether, we need hundreds of additional subjects to be involved."
BSI is also developing protein biomarker tests for breast and colon cancer, which Takacs said it plans to bring to market one to two years after the lung cancer diagnostic.