Qiagen receives CDSCO approval for NeuMoDx HIV-1, HBV and HCV quant assays in India for blood-borne virus testing

Qiagen, a Netherlands-based holding company, announced that its NeuMoDx human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) quantitative assays for blood-borne virus (BBV) testing has received Central Drugs Standard Control Organization (CDSCO) approval in India. These blood-borne virus assays are the first to be registered in India with additional NeuMoDx infectious disease assays to follow.

Every day, millions of patients infected with blood borne viruses such as HIV, HCV and HBV require routine testing to quantify their viral load in order to help assess the need to start, modify or stop antiviral therapy. These assays make use of Qiagen’s fully automated NeuMoDx molecular PCR platform that extracts and purifies DNA or RNA from blood to isolate the target nucleic acids and then conduct a real-time polymerase chain reaction (RT-PCR).

The NeuMoDx HIV-1 Quant Assay is designed for the quantitation and detection of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma. It can be used as an aid in the clinical management of HIV-1 infected patients and monitoring the effects of anti-retroviral treatment, as measured by changes in plasma HIV-1 RNA levels, and as an aid in the diagnosis of HIV-1 infection, including acute or primary infection.

The NeuMoDx HBV Quant Assay is designed for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum specimens for HBV genotypes A through H of HBV-infected individuals. It is intended to be used as an aid for determining proper course of treatment for patients with HBV infection.

The NeuMoDx HCV Quant Assay is designed for the quantitation of hepatitis C virus (HCV) RNA genotypes 1 through 6 in human plasma and serum specimens from HCV antibody positive individuals. It is intended to be used as an aid in the management of patients with HCV infections.

NeuMoDx has a simple and intuitive 3-step workflow. Room temperature stable Test strips, universal reagents and consumables are ready-to-use and can remain on board for a minimum of 7 days. The NeuMoDx system is always ready to run with minimal maintenance and waste generation it offers true random access testing capabilities and up to 8 hours walkaway time. The system can run up to 30 different assays and offers the versatility to run in-vitro diagnostics (IVD) certified assays, self-developed tests (SDTs) and RUO assays.

“India is one of the most populous countries in the world and still has high burden of communicable disease. The launch of NeuMoDx HIV-1, HBV, and HCV assays will provide significant benefits for patients with accurate and timely results. The test will play a vital role in controlling the spread of these diseases, addressing major needs for clinical testing in infectious diseases,” said Manoj Jagathmohan, director & head, India and South Asia at Qiagen.

With 16 EU-certified in-vitro diagnostics (CE-IVD) tests available, the NeuMoDx systems already offer one the broadest selections of tests on the market. The assays cover blood-borne viruses, transplant-associated viruses, sexual and reproductive health as well as respiratory diseases.

Qiagen N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life.

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