BUFFALO GROVE, Ill., March 2 /PRNewswire/ -- Efoora Inc. today announced that the United States Department of Agriculture (USDA) has approved the PDL CWD Rapid Antigen Test for use in the surveillance of Chronic Wasting Disease (CWD) in white tail deer. A transmissible neurological disease that affects white tail deer, mule deer and elk, CWD falls in the class of diseases called Transmissible Spongiform Encephalopathies (TSE) -- the same pathogen class that causes Mad Cow Disease (BSE) in cattle and scrapie in sheep. This is the first product developed by Efoora Inc. that has received United States government approval.
"The approval of our PDL CWD Rapid Antigen Test is a significant milestone for our company and represents the first of many approvals we expect to receive during the coming year," said David S. Grosky, chairman and CEO, Efoora Inc. and Prion Development Laboratories (PDL), Inc. "I applaud the contributions of our scientific team in achieving this milestone and look forward to additional product approvals in the near future."
Based on the Department of Natural Resources from 32 states in 2002, over 120,000 deer were tested for CWD.
The PDL CWD Rapid Antigen Test employs a proprietary lateral flow strip test technology. The major advantages of the PDL test are that it is simple, fast, and does not require sophisticated equipment. Results can be reported in approximately one hour. Validation testing yielded 100% Positive Predictive Value and 96% Negative Predictive Value when the PDL test was used on samples harvested from the white tail deer populations in Wisconsin. Currently, the same platform is being tested for use in detection of BSE and other TSE diseases.
"Our PDL CWD Rapid Antigen Test represents a significant departure from typical testing modalities for prion diseases," said Robert Petersen, Ph.D., executive VP and CSO, Prion Development Laboratories, Inc. "This approval provides further validation of our proprietary diagnostic technologies and we are anxious to demonstrate this innovative test in other TSE diseases."
About Prion Developmental Laboratories
Prion Developmental Laboratories, Inc. (PDL) is a subsidiary of Efoora dedicated to the design, development, and production of rapid diagnostic tests for Transmissible Spongiform Encephalopathies (TSE) diseases in animals and humans. PDL utilizes the manufacturing technology of the Efoora subsidiary Virotek, the wholly-owned, in-vitro diagnostic and medical device- manufacturing subsidiary of Efoora.
Efoora Inc. is a developer of rapid diagnostic tests and biosensors for a variety of diseases including HIV, hepatitis B and C, substance abuse, Bovine Spongiform Encephalopathy (BSE) and Chronic Wasting Disease (CWD). Efoora's flagship assay, the Efoora Rapid HIV test, recently completed U.S. clinical trials and is under review by the U.S. Food and Drug Administration. Efoora's test format utilizes an innovative biochemical approach developed as a result of years of research that yields both consistent and reproducible assays compliant under both GLP and GMP. Efoora's assays are manufactured using Virotek's proprietary, cost-saving technology. Virotek is the wholly-owned, in-vitro diagnostic and medical device-manufacturing subsidiary of Efoora.
For more information about Efoora and its subsidiaries, please visit http://www.efoora.com/ .
This release includes forward-looking statements, which reflect Efoora Inc.'s current view with respect to future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from historical or anticipated results. The words "believe", "expect", "anticipate" and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise. For a discussion of certain factors that could cause actual results to differ materially from historical or anticipated results, including investment risks, development risks and changes in the economic climate, please contact the Company.