Newark, New Jersey
January 18, 2001
Strategic
Diagnostics, Inc. (NASDAQ: SDIX) - a leading provider of analytical test kits for the agricultural, water quality and food testing markets, today
reported that the USDA Grain Inspection, Packers and Stockyards Administration (GIPSA) recently certified
a new SDI TraitCheck Bt9 Lateral Flow Test Strip with detection limits of one StarLink(TM) corn kernel in 800
non-StarLink(TM) kernels (0.125%) in less than 10 minutes.
The test strip had previously been validated at the 400 kernel testing level. The USDA and FDA have recently
established a 2,400 kernel sampling guideline to detect StarLink(TM) corn contamination in the US grain
distribution system. The new sensitivity will require only three samples to be tested, which has been the prior
practice before the FDA guidelines were issued. GIPSA will update its directive of official StarLink(TM)
testing methods to include this new performance validation. With this development, SDI continues to be the
leader in GMO testing.
To complement the new TraitCheck Bt9 Test Strip, SDI has also introduced the GMO QuickCheck Bt9 Test
Kit. The Company believes this rapid ELISA microwell format is ideal for field confirmation of screening
results for the Cry9C protein. With the plate format, up to 14 samples can be analyzed at one time with
results in less than 15 minutes. The ability to analyze multiple samples in a less than 15 minutes makes
this test kit an excellent confirmatory method when used in conjunction with the TraitCheck Bt9 Test Strip.
The GMO QuickCheck Bt9 Test Kit is currently undergoing validation by the USDA GIPSA.
In another new product introduction, SDI has completed validation of an improved GMO Check RUR Soya
Test Kit. This ELISA-based method can detect the presence of Roundup Ready(R) soybeans in processed
soya products used in the food and animal feed industries such as flours, de-fatted flakes, protein isolates,
protein concentrates, soymilk, tofu and toasted meal as low as 0.1%. Unlike the previously released version
of this product, the ability to detect the RUR protein in highly processed soy products is very unique and
represents a significant technical achievement. The introduction of this product is also very timely given the
European Union's (EU) concern over bovine spongiform encephalopathy (BSE), or mad cow disease, and
their move away from animal bone meal feeds to toasted soy meal animal feeds. Animal feed products are
regulated under the EU GMO guidelines.
Richard C. Birkmeyer, President and CEO of SDI commented, "The current concern around GMO testing
has created a unique opportunity for Strategic Diagnostics and we feel we have been recognized by the
industry as the leader in comprehensive analytical methods for the testing of GMO's. SDI has strong
relationships within the agricultural biotechnology, seed and grain industries. We have developed strip tests
and ELISA methods for all major traits currently in commercial production, including Roundup Ready(R),
Liberty Link(TM), Bt Cry 1Ab and Bt Cry 9C, all as a result of these relationships. We believe SDI is the only
company to provide lateral flow testing products for all of these traits. We have demonstrated that our tests
work in most major crops, including corn, soybeans, cotton and canola. Through the effective leveraging of
these relationships, we are developing tests for the next round of GM crops with two more to be introduced in
this quarter."
Mr. Birkmeyer continued, "We have focused our efforts on providing the industry with the appropriate
tools available for testing, along with the proper training on the usage of these tools, as we feel the best
advertisement is to have customers and regulatory agencies incorporating our test kits into policy and
practice. Toward this end, we feel that it is critical to focus our efforts on promoting the features and benefits
of our tests within the industry, since this ultimately sells test kits. The industry has recognized the efficacy
of our testing products, and in the last two years has utilized more than 8,000,000 lateral flow strips,
establishing us as the clear market leader. "
SDI is a leading provider of biotechnology-based diagnostic tests for a broad range of agricultural, industrial,
and water treatment applications. Through its antibody business, Strategic BioSolutions, Strategic
Diagnostics also provides antibody and immunoreagent research and development services. SDI's test kits
are produced in a variety of formats suitable for field and laboratory use, offering advantages of accuracy,
cost-effectiveness, portability, and rapid response. Trait Check (TM), GMO QuickCheck(TM), and GMO
Check(TM) are pending trademarks for SDI.
Company news release
N3264 |