hepatitis

The test is the second infectious disease assay from Bioneer to be CE marked, and the South Korean company has a third test in the pipeline.

Fresenius was alleged to have unnecessarily tested some dialysis patients for hepatitis B surface antigen and billing Medicare for the tests.

The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.

The program started in 2014, originally to increase access to HIV diagnostics, and provides special pricing to qualifying organizations in eligible countries.

The two organizations will seek to engage stakeholders worldwide in order to increase demand for and access to HCV diagnostics.

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

The firm said that the test provides results of HBV status in 15 minutes with high analytical sensitivity, and that testing can be completed while the patient is present.

Deck: Increases in denials from insurers, uncollectible patient balances, and reimbursement pressures negatively affected company revenues.