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