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Biosearch Wins Phase II SBIR from DoD to Develop RT-qPCR Tests for Exotic Pathogens

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Biosearch Technologies said yesterday that it has been awarded an $800,000 Small Business Innovation Research grant from the US Department of Defense to design and develop reverse transcriptase quantitative PCR assays to test for pathogens of military importance.

Under the Phase II SBIR grant, Novato, Calif.-based Biosearch will modify the assays for field deployment in overseas military operations, the company said.

Biosearch will use the funds to develop rapid assays for six arbovirus pathogens that are part of the top 20 pathogens in the Global Risk Severity Index compiled by the Armed Forces Medical Intelligence Center. Several of the agents are also listed as Category A or B priority pathogens by the National Institute of Allergy and Infectious Diseases.

According to an abstract for Phase I of the project, for which Biosearch received $100,000 last year, the company is specifically developing multiple combinations of qRT-PCR primers and probes for the pathogens that cause dengue fever, Rift Valley fever, Chikungunya disease, Crimean-Congo hemorrhagic fever, sandfly fever, and tick-borne encephalitis.

"Expected probe formats include hydrolysis probes, Scorpions, and molecular beacons," the abstract states.

In addition, as part of the project Biosearch was to design, synthesize, and sequence-verify positive control plasmids containing target amplicon sequences; and optimize assays for cycle profile, magnesium concentration, presence of competing nucleic acids, melting temperature, and gels to verify predicted amplicon length.

The abstract also states that "acceptable probes and primers will be manufactured under cGMP, and a minimum of 100 vials of at least one analyte assay provided to the military for testing; if successful, the expectation is assays for three of the six diseases by the end of [the] Phase I option."

The grant also covers the development of analyte-specific reagents for use in the tests, Biosearch said.

"Field-deployable assays for the rapid and specific detection of highly infectious and often lethal diseases in the field of operations are of paramount importance to military personnel," Jerry Ruth, director of research and development at Biosearch Technologies and principal investigator on the grant, said in a statement.

Ruth added that such assays may also be used to monitor the environmental source of such pathogens.

In August, Biosearch said that it had expanded a license with Qiagen giving Biosearch broad commercialization rights to Qiagen's Scorpions primer assays (PCR Insider, 8/12/10).

Earlier this year, the company also expanded a license with Roche Molecular Systems giving it the right to manufacture and sell validated PCR-based kits to the IVD marketplace as licensed products covered by multiple patents assigned to Roche (PCR Insider, 3/10/10).

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