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10/01/2009 - GenPrime Develops Innovative Biomedical E-reader

Driven by their own needs, GenPrime has developed the world's first universal automated lateral flow test strip reader. One example of lateral flow test strip usage is the home pregnancy test 'which contains a specialized paper strip on which marker lines may or may not appear. "Our reader is a dramatically better system, and we expect this system to become widely adopted for the analysis of all types of lateral flow tests," says Fleming.

Biotechnology Company GenPrime was founded in 1997 to develop microbe detection technology for managing the production performance of fermented products. Its first product, the GenPrime Yeast Activity Monitor, was introduced in June of 2000. Following the anthrax scares of October 2001, GenPrime developed Prime Alert® Biodetection System. The system is now being shipped to first responders and corporate security professionals globally. Always innovating, GenPrime scientists directed their creative efforts at other areas of bacterial detection in health care. One new area is the GenPrime Bacterial Contamination Test%u2122 for platelets and other biological fluids, which is currently under development. While the bacterial test was still being developed, the lateral flow reader software was completed, and GenPrime recognized the need for objective analysis of other lateral flow tests.

GenPrime's new test for bacteria is expected to be fast and accurate, sensitive, easy to use, and provide objective results, according to Jim Fleming, Chief Technology Officer. The results are made visible on a lateral flow indicator strip similar to the one on a home pregnancy test. Like the home pregnancy test, human error is the most common problem in interpreting the results. In many laboratories, a sample is taken, tested, and read by a technician who records the results on a paper form with check boxes. The information from the paper form may later be hand-entered into a database. The potential for transcription mistakes underscores the need for objective electronic data logging of test results, according to Fleming.

To solve this problem, GenPrime wanted a reader connected directly to a computer for the analysis of lateral flow tests. They searched and searched and finally concluded that there wasn't one available for purchase. What to do? "We're biologists, not software engineers," exclaimed Fleming. For a solution to the dilemma, they approached Steve McGrew of New Light Industries, Inc., who along with Jessie McGrew and Roger Wink, helped determine that such a reading device was indeed possible. With Jessie McGrew as lead programmer, the team set out to engineer the needed automatic data reading and recording instrument. They developed a "universal" reader that can easily be modified to read any lateral-flow strip, any density of lines, multiple lines, or any strip holding mechanism. "They can use it for fifty different tests if needed," says Fleming. "One major us e for this reader is in the analysis of drugs of abuse tests." Using drugs of abuse as an example, if the test is negative (no drugs present), there will be lines visible on the lateral flow strips. If drugs are present, no line will appear. Different lines may appear, or not, depending on which drug is present in the specimen. This makes accurate and objective reading and recording of the results even more imperative.

After lines appear on a lateral flow test, the reading process starts with an optical scanner. "We chose to use an optical scanner because the technology is mature and accurate 'specifically a scanner of high resolution," says Fleming. When the test is run, the client being tested is given either a bar code or an ID number. The lateral flow strips, with bar code, are placed on the scanner, and scanned. If there is an ID mismatch, the software will reject the test, so there will never be a wrongly placed result. With an ID match, a chain of custody is established.

The computer screen will show the scanned image. If drugs are present, the software will read and record which ones. The software keeps a copy of the image on file, leaving a good audit trail, so that results can be double checked at any time. The results page can be printed. The user can go back, connect to the database, make pdf's and e-mail scanned images to the physician or anyone else on a need-to-know basis. All this will eliminate the human error factor. The company submitted a patent application for the reader system in August of this year.

GenPrime is in the Terabyte Triangle at 157 South Howard in the Holley Mason Building. To learn more about GenPrime, visit www.genprime.com.

Billie Moreland
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