New Thermo Fisher Scientific facility to make COVID-19 testing kits in India for India
Applied Biosystems CoviPath COVID-19 RT-PCR Kit is approved for in vitro diagnostic use by ICMR and DCGI
The new state-of-the-art Thermo Fisher Scientific manufacturing facility in Bengaluru will produce COVID-19 testing kits and diagnostic solutions that are made in India for use in India.
CoviPath COVID-19 RT-PCR Kit, which contains the assays and controls for Thermo Fisher’s gold standard RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19. The kit is for use in India only, as per a company note.
The CoviPath COVID-19 RT-PCR Kit has been approved under MDR 2017 rules for in vitro diagnostic use by the Indian Council for Medical Research (ICMR) and Drug Control General of India (DCGI) in all authorised laboratories. Testing with the kit can be done on Applied Biosystems real-time PCR instruments with FAM dye, VIC dye, and JUN dye or any RT-PCR platform with 3 dye channels in molecular biology laboratories approved for testing. Samples are collected from nasopharyngeal swab, nasopharyngeal aspirate and bronchoalveolar lavage (BAL) specimens.
“Thermo Fisher has been playing a central role in the fight against COVID-19 pandemic. The introduction of this kit and the new facility strengthens our commitment towards the COVID-19 response in India. The new facility is equipped with the capacity to manufacture up to 10 million tests every month. This facility will be instrumental in ensuring access to affordable testing kits while maintaining global quality standards,” said Amit Chopra, managing director, India and South Asia, Thermo Fisher Scientific.
The CoviPath COVID-19 RT-PCR Kit is designed to detect viral targets with low mutations and offers more than 99.5 per cent sensitivity and 99.5 per cent specificity. The kit is packaged in a user- friendly and convenient pack size of 200 reactions. The company will make these kits available across the country leveraging its strong distribution network.
“As the country is racing to normalcy, it is imperative to have reliable, affordable and quick-to deliver testing kits. Thermo Fisher’s local production facility will augment accessibility of testing kits across the country. We are thankful to all our stakeholders and customers in extending their support,” said Kapil Sood, senior director, life sciences solutions, Thermo Fisher Scientific, India.