Improved diagnostic and monitoring assays for thyroid cancer

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,175,307.00
Award Year:
2013
Program:
SBIR
Phase:
Phase II
Contract:
2R44CA150324-02
Award Id:
n/a
Agency Tracking Number:
R44CA150324
Solicitation Year:
2013
Solicitation Topic Code:
NCI
Solicitation Number:
PA12-088
Small Business Information
18616 DEMBRIDGE DRIVE, DAVIDSON, NC, 28036-7824
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
Y
Duns:
609721019
Principal Investigator:
KENNETH PILLER
(704) 728-9753
KJPILLER@UNCC.EDU
Business Contact:
KENNETH PILLER
(704) 728-9753
KJPILLER@UNCC.EDU
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Thyroid cancer is the most common type of endocrine malignancy. New thyroid cancers patients are identified daily, and most patients live for decades following diagnosis. Thyroglobulin (TG) levels in the sera or in fineneedle biopsies of thyroid cancer patients are routinely quantified using various agency- approved (e.g. FDA) immunoassays for diagnostic and prognostic purposes. In fact, immunoassays to quantify TG levels are the gold standard for the diagnosis and monitoring process for these patients. One would anticipate that such frequently prescribed immunoassays would be highly reliable and easily interpreted. Unfortunately, this is not the case. The limitations of present day TG IVD immunoassays begin with the analytes required for their construction. Presently, TG must be obtained from human cadavers or from discarded human surgical tissue. This creates significant costs when purifying the protein from gland homogenates, and the problem of lot to lot variation bysupplier can be considerable. Furthermore, the presence of autoantibodies against TG in the sera of patients can interfere with these assays and their interpretation. Presently there is no solution to these problems or limitations. In this Phase II SBIR,we will continue our efforts to provide new solutions for both these problems. Using a novel platform technology, we have successfully expressed full length human TG in transgenic soybean seeds. To our knowledge, this is the only source of recombinant human TG, and is the only successful expression of this protein using any protein expression system. We propose that this renewable source of TG will prove to be more homogenous, easier to produce, and easier to purify than thyroid- derived TG. Further, we propose the construction of a device that can be used for the elimination of anti-TG autoantibodies from the sera of patients that can interfere with these immunoassays. If successful, these accomplishments should significantly enhance present day TG immunoassays designed to diagnose and monitor patients with thyroid cancers. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: In this Phase II SBIR, we will continue our efforts to solve two of the most significant problems plaguing FDA-approved thyroglobulin (TG) immunoassays. Expressing full length human TG in transgenic soybean seeds provides a renewable source of this analyte which has properties superior to the variability seen with lots of protein purified frm thyroid tissues. Furthermore, the unique advantages of transgenic soybean-derived proteins will allow, for the first time, a practical solution for the elimination of anti-TG autoantibodies that an interfere with immunoassays. These accomplishments should significantly enhance present day TGimmunoassays designed to diagnose and monitor patients with thyroid cancers.

* information listed above is at the time of submission.

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