Based on the results of a study presented this week at the American Association for Cancer Research's annual meeting, Celera said it is "expediting" commercialization of its mass spectometry-based lung cancer test.
Specifically, the company has assembled a panel of six protein biomarkers with the ability to detect non-small cell lung cancer in patients with 94 percent sensitivity and 93 percent specificity.
The company is conservatively estimating that the test will be launched by 2012. A Celera spokesperson told Pharmacogenomics Reporter this week that based on the study results presented at AACR, the company moved up commercialization plans for the lung cancer test by one to two years.
Celera will meet with the US Food and Drug Administration later this year, after planned validation studies for the lung cancer assay are complete, to discuss trial results, intended use of the diagnostic, and additional studies that may be necessary, according to the company spokesperson.
The study presented at the AACR meeting by Birse et al. involved 27 candidate biomarkers, which Celera researchers identified from 500 proteins previously identified in a pilot cohort of 12 lung cancer patients and 12 healthy controls. Among these 27 markers, the ones that showed elevated disease expression in cancer patients were then further validated in a group of 103 patients with non-small cell lung cancer and 104 healthy controls. In the study, there were 70 additional control subjects with non-malignant lung disease, which included bronchitis, asthma, COPD, and benign pulmonary nodules.
A blinded analysis was performed and a logistic regression classifier was generated using a collection of serum samples from 54 healthy subjects and 53 patients with tumors. Then, the classifier was evaluated on a panel of blinded samples, in which the six-marker panel achieved 94 percent sensitivity at 93 percent specificity in correctly classifying cases and controls.
"This panel and others described in the study are expected to provide the flexibility to design tests with performance specifications suitable for a variety of diagnostic applications, such as screening individuals at risk for lung cancer and for monitoring of disease following diagnosis and treatment," Celera said in a statement.
Ahead of a forthcoming paper discussing study results and the six protein markers, the Celera spokesperson held off on identifying the markers in the panel.
The panel could address the "serious concern" that the primary method that is currently used to detect lung cancer, computed tomography, "not only identifies malignant nodules but also benign, with significant expense and increased morbidity associated with managing these patients to determine whether the nodule is benign or malignant," the company said in a statement. "The ongoing study should begin to address whether the biomarker panel will help in this management of patients with solitary pulmonary nodules."
Celera is currently conducting several validation studies testing the assay's ability to discern between benign and malignant lung nodules, and is also looking at the specificity of the test on benign lung disease such as asthma, COPD, and bronchitis, as well as on other cancers.
"Review of our results with the FDA will help determine what additional studies would be required for FDA clearance," the spokesperson from Celera said.
According to the CDC, lung cancer has the highest mortality rate than any other cancer type. In 2005, the most recent year for which statistical data is available, more than 90,000 of 107,000 men diagnosed with lung cancer died. That same year, nearly 70,000 women out of more than 89,000 women diagnosed with the disease died. More people die from lung cancer than any other type of cancer.
"Currently, there are no guidelines for screening of individuals at risk for lung cancer, and current biomarkers are used only for monitoring of disease following diagnosis and treatment," the company said in a statement.
Depending on the results of the validation studies, the company will decide whether to pursue changes in lung cancer screening guidelines.
"For a screening application there may be a need for a much larger study on the high-risk smoking population prior to consideration of incorporation into guidelines," the Celera spokesperson said. "To be used in conjunction with helical CT in the current standard of care, a prospective study demonstrating the accuracy of the test to discriminate benign lung nodules from malignant nodules is in progress."
In the future, Celera may expand the indication of its mass spectrometry-based platform in colorectal and pancreatic cancer. At AACR, the company presented data on a seven-marker pancreatic cancer panel and a nine-marker colorectal cancer panel.
These tests are in the "very preliminary stages," but so far "have demonstrated high accuracy," the company spokesperson noted, adding that the launch of these tests is "years away."