VALIDATION PRODUCTS FOR CYSTIC FIBROSIS MOLECULAR TESTS

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$606,710.00
Award Year:
2002
Program:
SBIR
Phase:
Phase II
Contract:
2R44DK061880-02
Award Id:
60884
Agency Tracking Number:
DK061880
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
MAINE MOLECULAR QUALITY CONTROLS, 81 RESEARCH DR, SCARBOROUGH, ME, 04074
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
CLARKRUNDELL
(207) 885-2733
RUNDELL@MMQCI.COM
Business Contact:
JOANGORDON
(207) 885-8115
JGORDON@MMQCI.COM
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): This Phase II project develops a novel, comprehensive set of control products for quality assurance of molecular-based cystic fibrosis (OF) diagnostic tests. Controls are tested alongside patient specimens, as required by Federal regulations, to ensure quality in medical testing. Adoption of molecular diagnostics technology is inhibited by lack of commercial quality controls. Patient-based materials are often used as controls, which presents issues of patient confidentiality, infection risk and limited supply. Phase I research demonstrated feasibility of an innovative system for production of stable, renewable, noninfectious controls. In Phase II, constructs will be engineered to contain 16 medically important CF gene segments that carry forty-seven common CF diagnostic mutations. A unique cassette scheme for assembly of segments will yield a construct easily modified to accommodate new molecular tests. The construct will be stabilized by a proprietary technology and suspended in a biological matrix to mimic patient samples. Our control set will validate CF diagnostic assays and will serve as a model system to produce quality assurance products for genetic tests designed to detect multiple mutations. The availability of these products is important to medical diagnostics and makes a significant contribution to patient care by ensuring quality of genetic testing results. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

* information listed above is at the time of submission.

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