The U.S. FDA has given the green light to Roche Group for its Cobas HIV-1/HIV-2 Qualitative test for use on Cobas 6800 and 8800 systems. The test is the first FDA-approved, fully automated polymerase chain reaction (PCR) test that detects and differentiates between human immunodeficiency virus type 1 (HIV-1) and HIV-2, as well including claims for pregnant women and children.

“Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, CEO of Roche Diagnostics. “Being able to reliably determine a person’s HIV status and accurately diagnose which HIV type they may have is crucial for patients and health care providers in preventing further community transmission and selecting an individual’s best treatment options.”

Need for earlier detection

In 2018, roughly 1.2 million people in the U.S. were living with human immunodeficiency virus, the virus that causes autoimmune deficiency syndrome (AIDS), according to the CDC. Of those, more than 160,000 were unaware of their HIV status and just over half (53%) were virally suppressed, meaning there were low levels of virus circulating in their blood. That same year, nearly 38,000 people contracted HIV in the U.S.

Studies suggest that about half of all new HIV infections are transmitted between three days and three weeks of when a person becomes infected. However, identifying individuals in the acute period of HIV infection is hampered by current serology-based testing methods, which depend on the ability to detect an antigen or antibody response. Because it can take several weeks for a detectable antibody or antigen response to develop, individuals who are tested sooner may not generate a positive result.

By contrast, the PCR technology used in the Cobas HIV-1/HIV-2 Qualitative test is more sensitive and can narrow the time to detection by a week or more, Basel, Switzerland-based Roche said.

The test is an in vitro nucleic acid amplification test that that qualitatively detects and differentiates HIV type 1 and type 2 RNA in human serum and plasma. It is designed as an aid in diagnosing HIV-1/HIV-2 infection, as well as to confirm infection in individuals with specimens reactive for HIV-1 and HIV-2 antibodies or antigens.

Detects people in acute period of transmission

The assay could be especially helpful in identifying people in the acute stage of HIV infection by detecting HIV-1 or HIV-2 nucleic acid in plasma or serum without corresponding antibodies. It also differentiates between HIV-1, the most prevalent form of the virus worldwide, and HIV-2, which is primarily seen in West Africa. Cases of HIV-2 have been growing in the U.S., however, and distinguishing which type a person has is key to managing their disease.

The test is expected to be broadly available in the U.S. in 2021, a Roche spokesperson told BioWorld. It has been available in markets accepting the CE mark since 2017.

Last year, London-based Mologic Ltd. reported that it had completed development of an ultrasensitive lateral flow diagnostic with sensitivity of 1pg/ml. The diagnostic, which can be visually read at the point of care, is being utilized in the development of low-cost, high-performance devices for detecting HIV infections and malaria.

The HIV-1/HIV-2 Qualitative test is the latest Roche test approved for use on Cobas 6800 and 8800 high-throughput analyzers. In April, the FDA approved a test to identify women at risk for cervical cancer by detecting the presence of high-risk human papilloma (HPV) DNA in cervical samples. And the agency recently granted de novo class II authorization for the quantitative, in vitro detection of Epstein-Barr virus in DNA.

Roche also scored an emergency use authorization (EUA) from the FDA in March for its SARS-CoV-2 real-time PCR test that runs on the 6800/8800 systems.

Separately, Roche reported late Tuesday that it will launch a SARS-CoV-2 rapid antigen test later this month in countries accepting the CE mark. The point-of-care test is for use with both symptomatic and asymptomatic people, providing results in 15 minutes with 96.52% sensitivity and 99.68% specificity.

The company said it plans to apply to the FDA for an EUA for the test.

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