GEN Exclusives

More »

GEN News Highlights

More »
Jul 2, 2012

FDA Approves Roche's HIV Test

  • Roche’s COBAS® TaqMan® HIV-1 Test, v2.0, has been approved by the FDA. The test will be commercially available in the U.S. later this year.

    This HIV viral-load test targets two highly conserved regions of the HIV-1 genome and avoids any regions that are current drug targets. Roche says that this approach provides increased reliability as compared to other single-target assays should a mutation occur.

    “The approval of the Roche HIV test expands the availability to more laboratories, clinicians, and patients,” says Paul Brown, Ph.D., head of Roche Molecular Diagnostics. “Roche is committed to developing new diagnostic tools such as this HIV ‘dual target’ test to help improve the ability of physicians to monitor viral load and properly treat people living with HIV.”

    The COBAS TaqMan HIV-1 Test, v2.0 utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 analyzer for automated amplification and detection.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Alzheimer's Therapies

Do you think an effective treatment for Alzheimer’s will be found within the next 10–15 years?