Diagnostic Tests and Vaccines
2001.04.05

United Biomedical Inc. 
Synthetic Peptide-based Diagnostic Tests and Vaccines
for Foot-and-Mouth Disease

Web Page: www.unitedbiomedical.com

Wednesday, March 14, 2001

United Biomedical, Inc. (UBI) of Hauppauge,
NY,
USA

(http://www.unitedbiomedical.com) 
has developed advanced synthetic vaccines and immunodiagnostics for the currently raging Foot-and-Mouth Disease (FMD) animal pandemic. UBI developed its synthetic peptide-based products in face of the 1997 outbreak in Taiwan, a country that had been free of FMD since 1928. FMD is the most contagious disease of cloven-hoofed animals, including cattle, sheep and pigs. It carries dire economic consequences for the livestock industries of stricken countries. 

The economic dislocation and mass slaughter now underway in the UK and elsewhere in Europe are the costs of the effort to stop a sudden outbreak. The UBI synthetic peptide products will replace the previous killed virus technology and allow for widespread diagnostic screening and better and safer production of livestock.

The Company will be reporting on its new generation diagnostics and vaccines in April at the 4th Annual Conference on Vaccine Research in Arlington, Va. sponsored by the National Foundation for Infectious Diseases and in May at the Immunological Applications of Synthetic Peptides Symposium in Lyon, France organized by the Foundation Merieux and the International Association for Biologicals. UBI holds recently issued US patents 6,048,538 and 6,107,021 for its FMD products. A research paper written in collaboration with co-authors from the USDA describes the UBI immunoassay (Shen et al., Vaccine, 1999; 17:3039-3049).

UBI is the only organization in the world that is prepared to manufacture an FMD immunoassay on the scale needed for mass screening. The test can be used by any diagnostic laboratory as an invaluable tool to define the extent and duration of an outbreak and to minimize the mass slaughter used to confine it. The UBI diagnostic test, which detects infection within two weeks of exposure, uses synthetic peptide antigen to detect antibodies to the non-structural protein of the FMD virus (FMDV). Such a test can detect exposed and carrier animals in the absence of signs of infection. Also, contrary to standard FMD dogma, it is possible to differentiate infection from vaccination by an immunoassay when the assay has non-structural viral antigens for detection of antibodies (see the FAO/IAH/OIE website
http://alleffgroup.com/avisfmd for verification). 

The ability of the UBI non-structural test to differentiate infection from vaccination mitigates conventional protocols that call for the elimination of vaccinated animals as a prerequisite for the achievement or restoration of FMD-free status. Such a differential test can encourage the use of vaccination in countries that seek to eradicate FMD.

The UBI non-structural peptide-based immunoassay was independently evaluated in 17 countries under the auspices of the FAO/International Atomic Energy Agency Joint Division based in Vienna, Austria. The test has completed multiple field trials in Taiwan in collaboration with Taiwan Council of Agriculture. In all instances, the test had high sensitivity and specificity among vaccinated and unvaccinated populations, and the UBI test had excellent laboratory to laboratory reproducibility. 

This test, supplied as a simple-to-use indirect enzyme-linked immunoassay, is sold worldwide through a USDA export license (excepting our US domestic market). UBI has developed an additional confirmatory test to reduce the already low rate of false positives. Dr. Fred Brown of the USDA Plum Island Animal Disease Center, an eminent authority on FMDV, states that "The provision of a rapid test for identifying animals which have been infected with FMDV and distinguishing them from those that have been vaccinated is vital for the eventual eradication of the disease. Such a test is necessary because animals that have been infected frequently become carriers of the virus and the possible source of further outbreaks. 

The results obtained with a large number of sera from vaccinated, convalescent, and naive animals indicate that the UBI diagnostic test is both specific and sensitive."In parallel with its FMD immunoassays, UBI has been developing its FMD synthetic peptide vaccines. The UBI synthetic peptide design technology is readily adaptable for producing vaccines against all serotypes of FMDV. The first vaccine has been designed to confront the broad array of serotype O viruses that is responsible for the present pandemic. 

In studies conducted by three government laboratories on three continents, the UBI FMDV O vaccine effectively protected pigs from infectious challenge with FMDV O. Immunogenicity also has been shown in goats and the vaccine is expected to protect cattle. The UBI FMDV O vaccine elicited antibodies that neutralized a broader range of O virus subtypes than did a conventional FMDV O killed virus vaccine. The UBI vaccine is a synthetic chemically-defined product that holds no danger of residual infectivity. Unlike killed virus vaccines, it can be safely stored and used in an FMD-free environment. For added vaccine safety, the UBI non-structural immunoassay very readily distinguishes animals given the UBI synthetic vaccine from infected animals. 

The UBI FMDV O vaccine is being registered for use in Taiwan. It will become generally available pending further trials and regulatory registrations. The UBI FMD vaccine program is the subject of a strategic alliance with a major animal healthcare company. The UBI peptide-based products have the potential to revolutionize FMD practice. UBI's peptide-based products are absolutely safe to manufacture, store, and use because there is no involvement of infectious virus in the manufacturing process. 

The easy-to-use UBI non-structural immunoassay is safe for mass screening even in FMD-free countries. The test can define the boundaries of an outbreak, measure the progress of an eradication campaign, and minimize the mass slaughter used to stop an outbreak. Because the synthetic peptide immunoassay distinguishes vaccination from infection, the presence of vaccinated animals presents little danger. Thus, vaccination can become an acceptable component of an eradication program even in countries seeking FMD-free status. In the near future, the safety of vaccination will be assured by use of a chemically defined UBI vaccine. 

Pairing immunosurveillance by the UBI synthetic peptide immunoassays with vaccination by the new UBI peptide-based vaccines will provide for rapid and safe eradication programs, with minimum destruction of animals. United Biomedical, Inc., headquartered in Hauppauge, NY on Long Island, is a privately held international biopharmaceutical company developing immunotherapeutic, and immunodiagnostic products for human and veterinary use. The company manufactures immunodiagnostic kits for the blood screening market, including tests for HIV, hepatitis C, and syphilis, and manufactures a wide variety of pharmaceuticals through "UBI Asia," a joint venture with major investors from the Republic of China on Taiwan.

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