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Celera Hones Panel for Non-Small Cell Lung Cancer

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Celera has validated its mass spectrometry-based approach for identifying circulating protein biomarkers that detect non-small cell lung cancer at all stages and is currently in the process of deciding whether to commercialize a prognostic assay based on a six- or a nine-protein marker panel.

In collaboration with the New York University Langone Medical Center, Celera recently announced that it had replicated a "novel mass spectrometry-based approach to identify and validate circulating protein biomarkers that detect NSCLC in an independent cohort of individuals with lung cancer."

Celera presented results from early studies in April at the American Association for Cancer Research annual meeting. Based on results from these studies, Celera said at the time that it was "expediting" commercialization of its mass spectrometry-based lung cancer test.
Celera estimates the test would be launched by 2012. The test would have been launched much later were it not for these promising preliminary results, which allowed the company to move up commercialization plans for the lung cancer test by as much as one or two years.

According to Celera spokesperson David Speechly, results from the most recent study involving the lung cancer diagnostic confirm the company's "indirect" biomarker discovery approach by looking at lung cancer tissue from surgical resections, lung tumor cell lines, and the medium that the cell lines were grown in.

"Typically, in the detection of markers that are present at higher levels in the serum, one would use mass spectrometry to interrogate the serum itself and compare the results from serum of lung cancer patients with serum from healthy smokers," Speechly says. In contrast, Celera's approach "provides much less complexity for the mass spectrometry analysis."

Celera's clinical analyses have resulted in the validation of a nine-biomarker immunoassay on patient samples with Stage I NSCLC, which may be able to detect disease in the earliest stages.

— Turna Ray

PGx & Molecular Dx Notes

A genome-wide association study published in the Journal of the American Medical Association reports that the CYP2C19*2 variant of the cytochrome P450 gene influences Plavix response and treatment outcomes. Researchers at the University of Maryland School of Medicine studied more than 400 Amish people to find genetic variants that affect drug response.

Nanosphere has filed a 510(k) application to the US Food and Drug Administration for marketing clearance of its Verigene SP Respiratory Virus Assay, which detects influenza and respiratory syncytial virus.

In a study of type 2 diabetes in central Indiana, Bio-Serve will provide clinical biosample and other services to the Fairbanks Institute for Healthy Communities.

Datapoint

2
Geneuity Clinical Research Services validated and launched two assays to screen patients for kidney damage from drugs in clinical development.

Funded Grants

$390,000/FY 2009
Metabolome and Proteome Profiles of Emphysema and Airway Disease
Grantee: Russell Paul Bowler, National Jewish Health
Began: Apr. 9, 2009; Ends: Mar. 31, 2013

NHLBI issued this grant to determine a possible molecular basis for the different smoking-related phenotypes under the umbrella of chronic obstructive pulmonary disease. Bowler will use "proteomic and metabolomic approaches to identify new plasma biomarkers that are associated with COPD phenotypes" and then study those biomarkers further, says the abstract.

$746,861/FY 2009
Validation and Extension of an Existing Risk Model for Lung Cancer
Grantee: Carol Etzel, University of Texas,
MD Anderson Cancer Center
Began: Aug. 12, 2009; Ends: Jul. 31, 2011

This NCI grant will allow Etzel's team to build on an epidemiologic risk model for lung cancer by incorporating a genetic biomarker and then assessing it in 1,000 cases and 1,000 controls. The assay to be studied, the cytokinesis-block micronucleus assay, measures chromosome damage and other cellular events.

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