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J Transl Med. 2015 Feb 12;13:55. doi: 10.1186/s12967-015-0419-y.

Performance of a multiplexed dual analyte immunoassay for the early detection of non-small cell lung cancer.

Author information

1
20/20 GeneSystems, 9430 Key West Avenue, Rockville, MD, 20850, USA. vdoseeva@2020gene.com.
2
Abbott Molecular Inc, 1300 E Touhy Avenue, Des Plaines, IL, 60018, USA. Tracey.Colpitts@abbott.com.
3
20/20 GeneSystems, 9430 Key West Avenue, Rockville, MD, 20850, USA. yanshangao@gmail.com.
4
20/20 GeneSystems, 9430 Key West Avenue, Rockville, MD, 20850, USA. jwoodcock@2020gene.com.
5
20/20 GeneSystems, 9430 Key West Avenue, Rockville, MD, 20850, USA. vknezevic@2020gene.com.

Abstract

OBJECTIVES:

"PAULA's" test (Protein Assays Utilizing Lung cancer Analytes) is a novel multiplex immunoassay blood test that incorporates both tumor antigens and autoantibodies to determine the risk that lung cancer (LC) is present in individuals from a high-risk population. The test's performance characteristics were evaluated in a study using 380 retrospective clinical serum samples.

METHODS:

PAULA's test is performed on the Luminex xMAP technology platform, and detects a panel of 3 tumor antigens (CEA, CA-125, and CYFRA 21-1) and 1 autoantibody marker (NY-ESO-1). A training set (n = 230) consisting of 115 confirmed diagnoses of non-small cell lung carcinoma (NSCLC) cases and 115 age- and smoking history-matched controls was used to develop the LC predictive model. Data from an independent matched validation set (n = 150) was then used to evaluate the model developed, and determine the ability of the test to distinguish NSCLC cases from controls.

RESULTS:

The 4-biomarker panel was able to discriminate NSCLC cases from controls with 74% sensitivity, 80% specificity, and 0.81 AUC in the training set and with 77% sensitivity, 80% specificity, and 0.85 AUC in the independent validation set. The use of NY-ESO-1 autoantibodies substantially increased the overall sensitivity of NSCLC detection as compared to the 3 tumor markers alone. Overall, the multiplexed 4-biomarker panel assay demonstrated comparable performance to a previously employed 8-biomarker non-multiplexed assay.

CONCLUSIONS:

These studies confirm the value of using a mixed panel of tumor antigens and autoantibodies in the early detection of NSCLC in high-risk individuals. The results demonstrate that the performance of PAULA's test makes it suitable for use as an aid to determine which high-risk patients need to be directed to appropriate noninvasive diagnostic follow-up testing, especially low-dose CT (LDCT).

PMID:
25880432
PMCID:
PMC4335536
DOI:
10.1186/s12967-015-0419-y
[Indexed for MEDLINE]
Free PMC Article

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