From cosmetics, to supplements and pharmaceuticals- natural products using a wide-array of botanicals play an important role in our health and wellbeing. However, deceitful adulteration poses a great risk to the natural products industry and the safety of its consumers;there are a number of well-known cases involving substitution by toxic species that have led to illness and even death. There are numerous methods commonly used for botanical authentication- from microscopy, to chemistry, and infrared radiation- that vary in their ability to detect and identify adulterants. Although DNA-based technologies have not yet been widely used in industry, there are a number of methods that offer great potential for solving our challenges with adulterant detection, especially of closely related species. In the proposed project, we will develop a new test, Detect IDNATM, specifically designed to affordably and reliably, detect and identify adulterants and contaminants, even in processed materials such as capsules and botanical extracts. Detect IDNA"""""""" is based on an innovative method that integrates and refines two well- established technologies: Site-Targeted PCR analysis and DNA sequencing, which we have named """"""""Sequenced Site-Targeted PCR"""""""" (SSTP). The objectives of this proposal are to prove the technology and demonstrate the commercial viability of our Detect IDNATM testing line. We will accomplish these objectives with the following Specific Aims: (1) Design and Optimize an Array of PCR Primers;(2) Validate the PCR Primer Sensitivity and Specificity;and (3) Test the Applicability on Commercial Materials. For Phase I, we will demonstrate the applicability and significance of our method by analyzing three species, which have significant issues with adulteration: black cohosh, skullcap, and American ginseng. While American ginseng is commonly substituted by inferior relatives, the others are prone to adulteration by toxic species leading to great safety concerns for consumers.

Public Health Relevance

Accurate authentication of botanical ingredients used in natural products is arguably the most important factor in determining their quality and efficacy- after all without reliable means to confirm the identity of botanicals and assure the absence of contaminants, public safety is at risk. A wide-variety of authentication methods has been developed to combat issues with adulteration but there still remain three major weaknesses including differentiation between closely related species, detection and identification of low-levels of contamination, and authentication of materials that have been processed or are degraded. In this project we will enhance our service line by developing a novel test specifically design to affordably and reliably detect and identify adulterants and contaminants in a variety of commercial products, Detect IDNATM, which is based on an innovative method based on integrating two well-established technologies: Site-Targeted PCR analysis and DNA sequencing, which we have named Sequenced Site-Targeted PCR (SSTP).

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AT008292-01
Application #
8708332
Study Section
Special Emphasis Panel (ZAT1)
Program Officer
Hopp, Craig
Project Start
2014-07-01
Project End
2014-12-31
Budget Start
2014-07-01
Budget End
2014-12-31
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Authentechnologies, LLC
Department
Type
DUNS #
City
Richmond
State
CA
Country
United States
Zip Code
94806