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
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.
Read the full story.
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.
Read the full story.
To stay informed on the latest in infectious disease news and developments, please sign up for our weekly newsletter.