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S. Manetz
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P2.06 - Poster Session/ Screening and Early Detection (ID 219)
- Event: WCLC 2015
- Type: Poster
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.06-011 - Periostin Investigational Use Only Automated Immunoassay for Abbott ARCHITECT® (ID 283)
09:30 - 09:30 | Author(s): S. Manetz
- Abstract
Background:
Periostin is an 836 amino acid, 93314 Da, protein secreted by airway epithelial cells that induces cell attachment and spreading and plays a role in cell adhesion. Specifically, it functions to enhance incorporation of BMP1 in the fibronectin matrix of connective tissues, and subsequent proteolytic activation of lysyl oxidase. Its expression is induced by the Th2 cytokine IL-13. Periostin serum levels have shown to be elevated in some asthmatic patients. Therefore, it is hypothesized that periostin may be useful as a surrogate marker for IL-13 up-regulation and to identify asthmatics more likely to benefit from IL-13 targeted therapy. The clinical utility of the assay is being explored in patients with uncontrolled severe asthma in Phase III trials of tralokinumab, an investigational anti-IL13 monoclonal antibody. An analytically robust investigational use only (IUO) immunoassay was developed to quantitate serum periostin on the ARCHITECT® immunoassay iSystem.
Methods:
The ARCHITECT® Periostin assay is a monoclonal antibody (mAb) sandwich two‑step immunoassay for the quantitative determination of periostin in human serum using Chemiluminescent Magnetic Immunoassay (CMIA) technology. Periostin is captured by microparticles coated with an anti-periostin mAb and detected with a mAb conjugated with acridinium. Chemiluminesence is triggered, and signal is measured as relative light units (RLUs), which directly reflect to the quantitative amount of periostin. ARCHITECT® iSystem has throughput of 200 tests per hour. The analytical performance of the assay was assessed for sensitivity, linearity, precision, endogenous and drug interfering substances, specimen handling/preanalytics, and periostin isoform reactivity. The assay was standardized using gravimetrically prepared periostin isoform 1 with protein concentration determined using an extinction coefficient established by amino acid analysis.
Results:
Prototyping was performed on ARCHITECT® iSR2000. Numerous antibody formats were evaluated for key analytical performance prior to final pair selection and completion of extensive analytical performance testing. Limit of quantitation is
Conclusion:
The IUO ARCHITECT® Periostin immunoassay is a robust and reliable test for the measurement of serum periostin. Periostin testing is in progress in Phase III trials for tralokinumab, an anti-IL-13 human IgG4 mAb.
