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HIV

The test detects genomic drug resistance mutations in HIV-1 that can lead to treatment failure and is validated on the firm's automated Sentosa workflow. 

Abbott said that the MDx platform offers a number of initial assays, including tests for HIV-1, HBV, and HCV, among others.

Omega said that the technical file supporting its CE mark will form the basis for seeking additional regulatory approvals.

The agreement gives Inside Diagnósticos the right to sell Sienna’s hTERT test to pathology labs in Brazil for use as an adjunct to urine cytology.

The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.

The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.

The firm said net product revenues fell 11 percent year over year in the fourth quarter.

Researchers showed that the test had equivalent results to a lab-based assay and has the potential for a faster turnaround time. 

The test is a lateral flow, in vitro qualitative immunoassay that detects human antibodies to HIV virus type 1 and type 2 in whole blood.

The firm received approval for expanded use of its HIV Combo test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen, on its Vitros ECi/ECiQ Immunodiagnostic System.

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