LabCorp Launches Latest HIV Assay

Laboratory Corp. of America Holdings (LH) recently declared the availability of a 4th generation HIV antigen/antibody combination assay. A new diagnostic algorithm was also introduced to offer effective screening for HIV infection. Following the announcement, the company’s stock price rose 1.13%, and closed at $104.33 on Nov 7.

The New 4th generation HIV assays are equipped to simultaneously detect both the HIV antibodies (IgG and IgM) and the HIV p24 antigen prior to seroconversion. It is estimated that on an average, the 4th generation assay helps to detect HIV infection in acutely infected individuals, seven days earlier than results obtained using 3rd generation assays. The assay is an important addition to LabCorp’s test menu, which the company seeks to expand across multiple disease states.

In addition, the new diagnostic algorithm unveiled by LabCorp is expected to complement the findings of the assay and improve the screening and diagnosis of HIV infection. The Clinical Laboratory Standards Institute (CLSI) and the New York State Department of Health have also recommended the use of the enhanced algorithm for HIV screening.

The algorithm uses the 4th generation test as a first step. It subsequently confirms the initial HIV-positive result using an FDA-approved sensitive and specific immunoassay. This assay differentiates between HIV-1 and HIV-2 infections. Inconsistencies in results are further subjected to extensive nucleic acid testing to identify acute infection, if any, at an early stage.

At the moment, HIV infection has reached epidemic levels all around the globe. The Centre of Disease Control and Prevention (:CDC) recently estimated that around 1.14 million people in the U.S. are currently infected with HIV, with about 207,600 infections remaining undiagnosed. It is believed that the availability of such enhanced tests will help to break the infection cycle of the HIV virus and bring considerable improvement in diagnosis, treatment and control of this fatal disease.

Per management, the 4th generation HIV screening and associated supplemental testing will benefit HIV treatment by improving early-stage intervention and containment of virus transmission rates.

The Centers for Disease Control and Prevention (:CDC) has recently issued two positive evaluations of the new HIV diagnostic testing algorithm on its online Morbidity and Mortality Weekly Report. Both the assay and the algorithm promise to be cost-effective without compromising on quality. The usage of these comprehensive diagnostic products will provide physicians as well as patients with vital information necessary for screening, diagnosis and treatment of critical disease conditions.

Currently, the stock carries a Zacks Rank #3 (Hold). Other stocks that are worth a look in the medical/dental supplies industry include Align Technology Inc. (ALGN), McKesson Corp. (MCK), and Merit Medical Systems, Inc. (MMSI). All of them carry a Zacks Rank #1 (Strong Buy).

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