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antibody-based diagnostics

The foundation will provide funding of no more than $20 million over the four-year term of the deal, and no more than $6 million each year. 

The fourth-generation assay is for the in vitro qualitative assessment of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 in human serum and plasma.

Recent action from the FDA to reclassify certain point-of-care flu diagnostics means the agency will keep a closer eye on the tests' sensitivity and specificity.

The updated guidance comes on the heels of new data suggesting that for some individuals, antibodies to the Zika virus may stay in the body for months after infection. 

Israel-based Best Medical Opinion and South Korea-based Dow Biomedica/Biodiscovery will distribute Oncimmune's EarlyCDTLung cancer test in those countries.

MBL will use the technology primarily for its diagnostic reagents business. 

The test addresses a major challenge of using an immunoassay for diagnosing Zika — the inability to differentiate it from other flaviviruses. 

The firm is building an antibody-based immune system-related protein biomarker test for stroke diagnosis in both community and academic hospitals.

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