03 April 2020 | News
The company has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for its TaqPathCOVID-19 Combo Kit
Source: getty images
Thermo Fisher Scientific is accelerating its efforts with diagnostic testing and vaccine development technologies to effectively manage COVID-19 outbreak in the country.
In India, Thermo Fisher is working closely with the relevant government organizations as well as private testing laboratories to support scale up of testing. Thermo Fisher has been supplying reagents and other personal protective equipments to several government approved testing laboratories across the country.
These tests are performed on Real Time PCR instruments and can be conducted on other supplier instruments. The company has ramped up its efforts to produce these reagents and is well-positioned to cater to the growing requirement of conducting more tests as situation evolves.
Thermo Fisher Scientific has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for its TaqPathCOVID-19 Combo Kit for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL).
The company also received the CE mark in the European Union (EU) for its diagnostic test to detect COVID-19
The move comes in synchronization with utilizing Thermo Fisher’s Applied Biosystems Taq Path assay designed to provide patient results within four hours of a sample being received by a laboratory. The estimated time-to-result includes time for sample preparation and analysis. In addition to receiving the designated approvals in the U.S. and E.U., Thermo Fisher's diagnostic test has received the designated approvals in India, Canada, Singapore, Australia and New Zealand.
Amit Chopra, Managing Director, India and Middle East, Thermo Fisher Scientific said, “Thermo Fisher Scientific in India is geared to support COVID-19 testing initiatives to ensure priority access to instruments, consumables, safety supplies and other products to rapidly and efficiently respond to the outbreak. We are carefully managing our inventory, production and supply chains to ensure we continue to manufacture and deliver the products and services our customers rely on. It is times like these that reinforce our commitment to our mission which is to enable our customers to make the world healthier, cleaner and safer.”
Thermo Fisher has created an online resource to make it easier to find up-to-date information about its response to the COVID-19 pandemic, including availability of its diagnostic test kits.