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Case Study: A molecular diagnostic system that allows safe collection, transportation and identification of infectious agents.

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The history

longhornTraditionally, the diagnoses of infectious diseases relied on the safe freezing and transportation of a sample to a laboratory where it underwent testing—a process known as culture based testing. However, there are obvious practical difficulties associated with providing suitable refrigeration and storage conditions, particularly in remote areas. For disease management, initial safe sample collection and cold chain transport conditions are crucial to the rapid and accurate diagnosis of diseases such as tuberculosis, HIV and influenza.

Molecular diagnostic testing soon began to appear as an alternative testing method, one which relies on preserving the integrity of the DNA/RNA sample and which addresses some of the disadvantages of culture based testing, namely the requirement for specimen freezing. With molecular diagnosis, a sample of DNA/RNA is obtained from a sample, transported to a laboratory and identified using PCR analysis.

The invention

Longhorn Vaccines & Diagnostics LLC, a private biotech company located in Bethesda, Maryland, USA.. developed a novel molecular diagnostic system that allows infectious agents to be safely collected, transported and accurately identified. The collection system, known as PrimeStore, inactivates microbes from clinical and environmental specimens and prevents nucleic acid degradation during shipping and storage. DNA/RNA is preserved at ambient temperature without the need for refrigeration or freezing. Longhorn further developed a pathogen specific detection system, known as PrimeMix, which is an all inclusive, one-step PCR reagent mix for point of collection detection. PrimeMix is also temperature stable, and can be field deployed.

The intellectual property protection requirement

IP Gateway provided a consolidated and proactive approach to prosecution of patent applications for the PrimeStore and PrimeMix technology before the Australian and New Zealand Patent Offices. Australian Patents have been granted, with the New Zealand patent applications proceeding to grant in the near future.

The outcome

IP Gateway is pleased to have been able to provide a proactive and consolidated approach to provide patent protection for an invention of this calibre, which has already demonstrated the potential to make a real difference in the treatment of infectious diseases. This can be witnessed with the Longhorn A/H1N1-09 Prime RRT-PCR Assay employed as the first collection to detection assay for the 2009 H1N1 Influenza virus (swine flu). In response to the public health emergency declared in 2010 by the US Secretary of Health and Human Services during the swine flu outbreak, the US Food and Drug Administration (FDA) authorised emergency use of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay to test for the presence of swine flu virus in clinical respiratory specimens.