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Rapid Virus Detection

PositiveID’s rapid virus detection system is a non-invasive, point-of-care test to test patient samples and identify various forms of influenza within minutes. PositiveID’s virus triage diagnostic system, based on PositiveID’s development partner RECEPTORS' patented AFFINITY by DESIGN CARA platform exclusively licensed to PositiveID, will use a multiplexed read-out (multiple end-points that can be read in a single scan) to produce a fingerprint that will both detect the presence of influenza virus and identify the specific influenza sub-type (e.g. pandemic H1N1 versus seasonal sub-types).

Moreover, this test will be in a simple test tube or strip device format, in combination with a nasopharyngeal swab, which can provide a quick test result, ideally in less than 10 minutes. It will also act to alert the user to the presence of pandemic threat viruses .

.In February 2010, PositiveID announced the successful completion of Phase I development of the virus detection system. In Phase I development of the system, the company successfully achieved proof-of-concept. CARA support and complementary competitor agents were developed to detect the presence of influenza in a model nasal wash matrix. The fluorescently labeled competitor agents compete for binding to the CARA support surface. When competitor agents are displaced from the CARA surface by virus, a fluorescent signal is produced. Model nasal wash samples that contain influenza are distinguished from samples that do not contain influenza.

Phase II development, which the Company expects to complete by the end of 2010, is now underway. Using multiplexed specificity, the goal of Phase II is to classify the sub-type of influenza that is present in a sample, such as H3N2 (seasonal flu), H1N1 (swine flu), etc. Rapid sub-type classification of influenza strains at the point of care will allow for improved treatment, thereby discouraging antibiotic overuse, preventing central lab overloading and improving overall health outcomes. Furthermore, the rapid virus sub-type test will give an early warning of the rise of new sub-types of influenza so that containment measures can be implemented and pandemic proportions can be avoided.

The current gold standard for influenza sub-type identification relies on either a polymerase chain reaction test or culture approach, neither of which is a quick (or inexpensive) test. The current crop of quick test products on the market is only capable, due to limitations in their technology platform, of providing a yes/no answer to the presence of influenza. The development partners published a white paper in May 2009 entitled, "An Integrated Sensor System for the Detection of Bio-Threats from Pandemics to Emerging Diseases to Bioterrorism.”

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