Bio-Rad Laboratories, Inc., a global provider of life science research and clinical diagnostic products, has received Premarket Application approval from the U.S. Food and Drug Administration (FDA) for Bio-Rad's Geenius HIV 1/2 Supplemental Assay.
The Geenius HIV 1/2 Supplemental Assay is a single-use immunochromatographic assay intended for use as an additional, more specific, test to confirm the presence of and differentiate antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) for specimens found to be repeatedly reactive by diagnostic screening procedures. The assay may also be used to confirm the presence of antibodies to HIV-1 and/or HIV-2 in pediatric subjects as young as two years old.
The company is promoting the product as a faster and easier alternative to Western blot, and an objective alternative to Bio-Rad’s Multispot HIV-1/HIV-2 Rapid Test. Company spokespersons say that the Geenius HIV 1/2 Supplemental Assay offers a three-step procedure that produces clear, onscreen results in 30 minutes with full traceability. The Geenius Reader can then analyze and interpret reaction results for HIV-1 (p31 HIV-1 polymerase peptide, gp160 HIV-1 recombinant protein envelope, p24 HIV-1 recombinant protein core, and gp41 Group M and O HIV-1 peptide envelope) and for HIV-2 (gp36 and gp140 HIV-2 peptide envelope).
In designing the Geenius HIV 1/2 Supplemental Assay, Bio-Rad developers worked closely with the Centers for Disease Control and Prevention (CDC) to ensure the assay would align with the second step of the HIV testing algorithm that the CDC recommended in June 2014. Company representatives stress that this assay has moved confirmatory testing fromsubjective reading and interpretation to objective reading and interpretation by using a reader and proprietary software.
“Bio-Rad is pleased to offer its Geenius HIV 1/2 Supplemental Assay,” says John Hertia, Bio-Rad Executive Vice President, President, Clinical Diagnostics Group. “Using the assay, clinicians are able to help HIV-infected individuals get the correct treatment they need more quickly.”Read more from the FDA