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Plasmid DNA positive control standards for molecular environments assays

Award Information
Agency: Department of Commerce
Branch: National Oceanic and Atmospheric Administration
Contract: WC-133R-17-CN-0074
Agency Tracking Number: 17-1-016
Amount: $112,323.42
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 8.4.3
Solicitation Number: NOAA-2017-1
Solicitation Year: 2017
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-06-19
Award End Date (Contract End Date): 2017-12-18
Small Business Information
1600 Range Street Suite 201
Boulder, CO 80301
United States
DUNS: 933159212
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 John Woods
 (303) 546-9300
Business Contact
 John Woods
Phone: (303) 546-9300
Research Institution

The proliferation of sensitive DNA-based assays for detecting the presence of specific harmful,
toxic or invasive organisms, as well as the simple reagent and instrumentation requirements for
these assays has made widespread and more frequent testing for these different organisms
possible. However, a frequent problem with such assays is the lack of available, well-quantified
positive control standards for all laboratories running a particular assay. This lack of
standardized positive controls greatly hampers both evaluating the correct performance of the
assay and comparing results between samples taken at different times, by different individuals,
or tested with different assays. Many laboratories carrying out DNA-based assays make their
own standards in small batches. These are generally tedious to make, poorly quantified and
hard to reproduce, as well as a source of contamination potentially causing false positive
results. We propose that plasmid DNA based positive control standards, containing a synthetic
DNA sequence, mimicking, but distinguishable from, the natural target sequence of the
organism, and quantified using a simple statistical test can be made accurately, economically
and in almost unlimited quantities. Such standards would foster the expanded use of DNAbased
detection assays, and equally importantly, facilitate comparison of results between
different samples, laboratories and assays.

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