FDA Approves Roche’s HIV Qualitative Test

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #cobas #fda #hiv #hiv-1 #hiv-2 #qualitative #roche #test


PRICENTRIC BRIEF:
  • Roche announced the U.S. Food and Drug Administration (FDA) approval for the cobas HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas 6800/8800 Systems in the U.S.
  • 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 and to prevent “further community transmission”
  • Current serology-based testing methods rely on the ability to detect an antibody or antigen response and thus work too slowly at times since it can take multiple weeks for a detectable antibody or antigen response to generate—The cobas HIV-1/HIV-2 Qualitative Test’s higher sensitivity of PCR technology can reduce this time-to-detection period by one week or more

THE DETAILS

BASEL, Switzerland — Roche announced the U.S. Food and Drug Administration (FDA) approval for the cobas HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas 6800/8800 Systems in the U.S.

The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2. It is important to distinguish between HIV-2 infections and HIV-1 infections because they require different clinical management.

“Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, CEO 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 healthcare providers in preventing further community transmission and selecting an individual’s best treatment options.”

Studies show that 50% of new HIV infections may be transmitted during the acute period, between three days and three weeks from the time of infection.

However, current serology-based testing methods rely on the ability to detect an antibody or antigen response and thus work too slowly at times. They can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate.

The higher sensitivity of PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by one week or more.

The U.S. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 million people were living with HIV in the United States. Among them, more than 160,000 people did not know their HIV status, and only 53 percent were virally suppressed having low amounts of virus circulating in their blood. During this same year, 37,968 people became newly infected with HIV2.

Worldwide, most HIV infections are HIV-1, whereas HIV-2 largely has been confined to persons in or from West Africa. However, HIV-2 has been steadily increasing in the U.S. due to immigration.

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