FDA Approval for APTIMA® HIV-1 RNA Qualitative Assay for Clinical Diagnostic Use

The FDA has granted marketing approval for the APTIMA® HIV-1 RNA qualitative assay. The assay may be used as an aid in the diagnosis of acute and primary HIV-1 infection, and to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive (positive) for HIV-1 antibodies.

The assay is the first FDA-approved qualitative nucleic acid test (NAT) for these intended uses.

Gen-Probe expects to launch the assay in November in conjunction with the APTIMA HCV (hepatitis C virus) RNA qualitative assay. Detection of HCV RNA is evidence of active HCV infection. The APTIMA HCV assay may be used to detect HCV RNA in individuals with antibody evidence of HCV infection and evidence of liver disease, individuals suspected to be actively infected with HCV with antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.

Qualitative assays detect the presence of viral genetic material and give a "yes-no" answer as to whether the target virus is present. In contrast, quantitative assays are used to estimate the amount of genetic material present in a sample. Gen-Probe's new viral products are not approved for quantitative use.

In September, the U.S. Centers for Disease Control and Prevention (CDC) published new recommendations for health care providers that are designed to make voluntary HIV screening a routine part of medical care for all patients aged 13 to 64. The CDC estimated that more than 250,000 Americans are HIV-positive but unaware of their condition, and said that early diagnosis is critical in order for people with HIV to receive life-extending therapy.

A recent article in the journal Hepatology (Vol. 44, No. 2, 2006) illustrated the value of monitoring patients with chronic hepatitis C infection with a highly sensitive nucleic acid test. In the study, independent academic researchers retrospectively tested stored blood samples with an assay identical to the APTIMA HCV RNA qualitative assay. The authors concluded that negative results with this assay were more predictive of sustained virological response (SVR) than were negative results achieved with a less sensitive polymerase chain reaction (PCR)-based assay. According to the authors, SVR is an important endpoint associated with durable eradication of HCV infection and long-term remission, if not cure, of disease.