The company has received licensing rights from Central Drugs Standard Control Organisation (CDSCO) and will be manufactured in India in association with Mylab Discovery Solutions
Designed to deliver confidence and reliability for diagnostic development and testing, the Applied Biosystems TaqPath PCR kits by Thermo Fisher Scientific for infectious diseases such as Multi-Drug Resistant Tuberculosis (MTB MDR), M Tuberculosis complex (MTB), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), and for genetic analysis (HLA B27), have received licensing rights by the Central Drugs Standard Control Organisation (CDSCO) and will be manufactured in India in association with Mylab Discovery Solutions.
The Applied Biosystems TaqPath PCR kits have been analytical- 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 offers a complete qPCR ecosystem, which includes the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System and upcoming QuantStudio 7 Pro Dx Real-Time PCR Systems designed to simplify workflows, a broad portfolio of master mixes and PCR plastics, RNA/DNA for sample preparation and biosafety cabinets, centrifuges, cold storage, pipettes and tips to support the entire end-to-end workflow of any diagnostic lab.
“Over the years, India has made significant progress in addressing infectious diseases such as Hepatitis B and C, HIV, and Tuberculosis. The country has implemented large-scale vaccination and treatment programs, as well as invested in research to better understand the epidemiology of these diseases and develop new diagnostic tools. However, India still faces challenges in controlling the spread of these diseases. At Thermo Fisher Scientific, we are committed to offering new innovations and workflows to advance research and diagnosis of these infections while actioning our mission, to enable our customers to make the world healthier, cleaner and safer”, said Jagjit Singh Anthak, Director, Genetic Sciences Group and Specialty Diagnostics Group, Thermo Fisher Scientific.
Feature are:
- High sensitivity to detect low-copy targets with reproducible Ct results
- Wide dynamic range compatible with multiplexing applications
- Tolerant of inhibitors commonly found in clinical samples
- Manufactured in an ISO-13485 facility to help ensure excellent manufacturing consistency
- Exceptional data quality- high specificity, dynamic range*, and reproducibility for genotyping and copy number determination
- Tolerance to inhibitors- compatible with samples prepared from human or animal sources (buccal swabs, blood, and card punches)
- Multiplexing breadth—detect up to 4 targets per reaction
- Excellent manufacturing quality—manufactured in an ISO 13485–certified facility
“We are proud to be associated with Thermo Fisher and develop world-class molecular diagnostics kits,” said Hasmukh Rawal, MD, Mylab Discovery Solutions. “Laboratories in India and globally rely on the innovative products from Thermo Fisher, and will now also benefit with a much wider range of quality diagnostic tests. Also, we would be assisting in tools for the analysis of data to help labs make accurate results for their customers. This is a milestone moment in Indian diagnostics.”
