New Avian influenza assays developed by VLA expected to expand upon the existing Applied Biosystems Avian Influenza A/H5 detection kits

Applied Biosystems, an Applera Corporation business, and the Veterinary Laboratories Agency (VLA), a UK government agency specializing in animal disease surveillance and veterinary research, today announced a strategic collaboration to manufacture and commercialize the VLA’s molecular avian influenza and Newcastle disease environmental detection kits.

These kits are expected to be broadly available in Europe and other parts of the world, such as Asia and Africa. This collaboration is intended to help early detection of these harmful bird diseases, which is a critical step in managing the threat posed by these diseases.

The VLA has used these tests to confirm that the avian flu strain that recently killed 2,600 turkeys in Suffolk, England was the H5N1 virus. It was the first reported case of H5N1 on a UK commercial farm. The agency said that early detection enabled immediate response to contain the outbreak. These tests have also been used in a follow-up enhanced survey of the wild bird population.

The goal of the VLA and Applied Biosystems agreement is to make these types of tests - known as assays - more readily available for the same type of early warning detection in various countries. In addition to the Influenza A virus and its H5 subtype, the assays are also expected to address the H7 subtype and Newcastle disease. The new assays are designed to rapidly and reliably detect a broad range of avian influenza strains in laboratory samples.

“This collaboration agreement between Veterinary Laboratories Agency and Applied Biosystems is an ideal opportunity to combine both VLA’s experience and expertise of these two very important avian diseases and Applied Biosystems’ expertise and manufacturing skills,” said

Professor Steve Edwards, chief executive of VLA. “As with any notifiable disease, rapid
confirmation is essential for control measures to be implemented quickly and to minimise the impact. These molecular detection methods should help to improve, sensitivity, specificity and turnaround time. We look forward to a long and successful partnership.”

Under the terms of the agreement, Applied Biosystems will commercialize the VLA real-time PCR assays. Real-time PCR is a laboratory method used to simultaneously detect and determine the amount of nucleic acids present in samples. Applied Biosystems was chosen due to its expertise in the area of avian influenza detection, its broad portfolio of avian flu kits based on TaqMan^® real-time PCR technology, its commercial manufacturing scalability and its specialty in producing reliable tests that require fewer processing steps.

The VLA assays are veterinary molecular tests that are used in a laboratory. Applied Biosystems intends to further develop these assays in a new dry format designed to render more reliable results by consolidating steps in the testing process and minimizing manual procedures. The VLA will perform the validation prior to the release of the tests, which are intended for use in animal health laboratories around the world outside the United States.

Applied Biosystems currently has an installed base of over 1,400 real-time PCR platforms in public health laboratories across Europe, Asia, and Africa capable of running avian influenza TaqMan^® assays. Applied Biosystems’ current TaqMan^® Influenza A/H5 Detection Kits are manufactured in Warrington, UK. Today’s announcement extends the Applied Biosystems international initiative to ensure that detection kits and up-to-date genomic data are available for priority infectious disease threats.

“Laboratories responsible for disease surveillance in many different countries continue to increase preparations for any possible outbreak of avian influenza and other infectious diseases,” said Lars Holmkvist, president of Applied Biosystems, Europe. “Providing animal health laboratories with the tools for a reliable early warning system demonstrates Applied Biosystems’ commitment to support a global network of laboratories and to partner with leading agencies, such as the VLA, to bring reliable tests to market as quickly as possible.”

Avian influenza is an infectious disease of birds caused by the type A strains of the influenza virus. The H5N1 subtype has evolved into a virus that has the potential to infect humans. If contracted, it has the capability to cause serious illness or death in extreme cases. Certain strains of influenza A virus also have the ability to mutate into strains with differing pathogenic profiles. Newcastle disease virus is a highly contagious, notifiable disease caused by a Paramyxovirus, type 1, that affects domestic poultry and many species of wild birds. The clinical signs include depression, lack of appetite, respiratory distress, coughing and sneezing.