The ID Pipeline: HIV Differentiation, SARS-CoV-2, and Influenza A/B Testing

The following is a quick review of the week’s top FDA approvals and authorizations:

FDA Approves Combination HIV-1/HIV-2 Test

The US Food and Drug Administration (FDA) has approved a Roche polymerase chain reaction diagnostic (PCR) which allows both qualitative detection and differentiation for HIV diagnosis.

The HIV-1/HIV-2 Qualitative will be available for use on the existing cobas 6800/8800 Systems.

It is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.

"The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options," a Roche statement reads.

50% of new HIV infections may be transmitted during what is known as the "acute period," 3 days to 3 weeks from the time of infection, according to data cited in the Roche statement.

This makes rapid diagnosis and connection to correct care essential in the fight against HIV/AIDS.

Regulators may have been motivated to go forward with approval by the fact that predominant serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection early on.

If a person is tested prior to having a detectable antibody or antigen response, a false sense of security and thus further HIV transmission is possible.

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Roche Receives EUA for its SARS-CoV-2 and Influenza A/B Test

Roche announced today it had received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 & Influenza A/B Test.

This test offers the ability to detect and differentiate between SARS-CoV-2, influenza A and B.

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” Thomas Schinecker, CEO of Roche Diagnostics, said.

The company’s fully-automated cobas 6800/8800 Systems can provide up to 96 results in about 3 hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour period.

The test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the detection of the aforementioned viruses in nasal or nasopharyngeal swab samples.

This test is also available in Europe.

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