INDIA – The Central Drugs Standard Control Organisation (CDSCO) has cleared Thermo Fisher Scientific’s real-time PCR kits for the detection of infectious diseases in India.
The license allows Thermo Fisher Scientific and Mylab Discovery Solutions to design, develop and market the Applied Biosystems TaqPath PCR kits for infectious diseases across the country.
The Applied Biosystems TaqPath PCR kits are designed to deliver confidence and reliability for the diagnostic development and testing of specific antiviral antibodies.
“The Applied Biosystems TaqPath PCR kits have been analytically- and clinically-validated for use in patient care for disease screening and diagnosis, monitoring of therapeutic response and disease progression, and identification of genetic risk factors,” Thermo Fisher Scientific said in a release.
The real-time PCR kits can be used for the qualitative detection of Multi-Drug Resistant Tuberculosis (MTB MDR), M. Tuberculosis complex (MTB), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV), and for genetic analysis (HLA B27).
Key features of the Applied Biosystems TaqPath PCR kits include high sensitivity to detect low-copy targets, wide dynamic range compatible with multiplexing applications, excellent manufacturing quality, exceptional data quality, and tolerance to inhibitors.
“At Thermo Fisher Scientific, we are committed to offering new innovations and workflows to advance research and diagnosis of infectious diseases,” stated Jagjit Singh Anthak, Director of Genetic Sciences Group and Specialty Diagnostics Group at Thermo Fisher Scientific.
Jagjit Singh outlined that the launch of the Applied Biosystems TaqPath PCR kits aligns with the company’s mission to enable its customers to make the world healthier, cleaner, and safer, adding that India has made significant progress in addressing infectious diseases.
With the launch of the Applied Biosystems TaqPath PCR kits, Thermo Fisher Scientific will expand its product portfolio, which includes the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System and upcoming QuantStudio 7 Pro Dx Real-Time PCR Systems.
The American supplier also offers a broad portfolio of master mixes and PCR plastics, RNA/DNA for sample preparation, along with biosafety cabinets, centrifuges, cold storage, pipettes, and tips to support the entire end-to-end workflow of any diagnostic lab.
On his part, Hasmukh Rawal, Managing Director at Mylab Discovery Solutions, said: “We are proud to be associated with Thermo Fisher to develop world-class molecular diagnostics kits.”
Rawal pointed out that laboratories in India and worldwide heavily rely on Thermo Fisher’s innovative molecular diagnostic products from Thermo Fisher, noting that the Pune-based biotechnology company will benefit from the wider range of quality diagnostic tests.
“We will produce tools for analysis of data to help labs make accurate results for their customers. This is a milestone moment in Indian diagnostics,” he added.
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