Thermo Fisher Scientific Inc. TMO recently launched its Applied Biosystems HIV-1 Genotyping Kit with Integrase. This research only evaluates positive human immunodeficiency virus (HIV) samples to detect genetic variants that resist common antiretrovial therapeutics.
The improved research assay is compatible with the company’s Applied Biosystems MagMAX Viral/Pathogen Nucleic Acid Isolation Kit for HIV-1 Blood Spots. It equips laboratories with a standardized tool for drug resistance surveillance of HIV mutations to antiretroviral therapeutic inhibitors, which can help identify global areas of need.
More on the New Assay
The Applied Biosystems HIV-1 Genotyping Kit will analyze HIV RNA extracted from EDTA plasma or dried blood spots to measure genomic mutations in the protease, reverse transcriptase and integrase regions of the pol gene. The findings from these tests will help inform global epidemiologic and genetic surveillance studies to monitor the continued evolution of the virus.
The Applied Biosystems HIV-1 Genotyping Kit has been designed to support the identification of the Joint United Nations Programme on HIV/AIDS (UNAIDS) 2030 95-95-95 HIV targets. Per management, the knowledge of the viral resistance genotypes that exists in a given population is critical to identifying new public health treatment strategies. The monitoring for treatment-resistant strains of HIV can improve the global understanding of the virus.
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The Applied Biosystems HIV-1 Genotyping Kit will analyze expanded targets associated with HIV drug resistance, including mutations in the integrase region of the pol gene on Applied Biosystems Sanger sequencing CE instrumentation. It has been designed to offer broad Group M subtype coverage to address regions of the world with the greatest need, such as Africa, Latin America, India and portions of Asia, where global health access pricing is available.
Per a report published in GlobeNewswire, the HIV diagnostics industry is expected to see a CAGR of 0.8% between 2022 and 2028. Factors such as the high prevalence rate of HIV in low- and middle-income countries, growing awareness regarding regular antibody tests and favorable government initiatives can be attributable to market growth.
Given the market prospects, Thermo Fisher’s new launch seems strategic.
Other Notable Developments
In July 2022, Thermo Fisher launched the Applied Biosystems TaqPath Respiratory Viral Select Panel, which can detect five common viruses within three hours. This CE-IVD-marked molecular assay panel leverages highly-accurate PCR technology to test for Adenovirus, Human Metapneumovirus, Rhinovirus/Enterovirus, and Parainfluenza virus. It also consists of RNase P and positive controls to offer sample-to-result reliability.
In June 2022, the company gained FDA approval for the Thermo Scientific EliA RNA Pol III and EliA Rib-P tests to aid in the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE). The EliA portfolio now offers a more robust clinical offering through a comprehensive menu of automated connective tissue disease tests, with the addition of these two new blood tests. The two novel tests are intended to improve the differentiation of SSc and SLE from other connective tissue diseases.
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The HIV diagnostics market is competitive with the presence of prominent MedTech players.
In this regard, we may note that Hologic, Inc.’s HOLX Aptima HIV-1 Quant Dx assay which gained additional FDA approval for use as an aid in the diagnosis of HIV infection. This molecular diagnostic test runs on Hologic’s fully automated, sample-to-result Panther system. It is the first dual-claim assay for diagnosis and viral load monitoring in the United States.
The dual-claim benefits HOLX’s clinical laboratory customers who continuously seek to consolidate their testing into one automated platform.
Another notable player, Abbott Laboratories ABT offers the first viral load point-of-care test, m-PIMA HIV-1/2 VL, for HIV management, especially in remote and underserved communities. The m-PIMA HIV-1/2 VL test by Abbott provides viral load test results in less than 70 minutes. This life-changing technology enables patients to get tested and treated in the same visit.
ABT’s m-PIMA HIV-1/2 VL test is commercially available in select countries and has gained CE-IVD marking and WHO prequalification.
To aid in HIV diagnosis, Bio-Rad Laboratories, Inc. BIO offers the FDA-approved BioPlex 2200 HIV Ag-Ab assay, the company's 5th generation HIV diagnostic test. This assay facilitates the early detection of HIV by detecting HIV antigens and HIV antibodies. It also provides more information by specifically identifying which individual HIV-1 or HIV-2 marker is positive.
The BioPlex 2200 HIV Ag-Ab assay is part of Bio-Rad’s growing infectious disease menu of the BioPlex 2200 system.
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