Thermo Fisher Scientific launches RT-PCR test kits designed and made in India

Thermo Fisher Scientific, the US-based maker of laboratory equipment said it has opened new manufacturing facility in Bengaluru to produce COVID-19 RT-PCR test kits under brand name CoviPath developed in India, to meet local cold chain conditions and testing laboratory requirements.

The company said the RT-PCR test kit is designed to detect viral targets with low mutations and offers more than 99.5 percent sensitivity and specificity.

RT-PCR (Real-time reverse transcription polymerase chain reaction) kits are considered the gold standard for COVID-19 tests due to its high sensitivity, compared to the rapid antigen tests that throw more false results.

Thermo Fisher said CoviPath RT-PCR Kit has been approved by the Indian Council for Medical Research (ICMR) and Drug Control General of India (DCGI), and can be used on any RT-PCR platform with 3 dye channels in laboratories approved for COVID-19 testing.

The RT-PCR test kits doesn't need ultra cold storage freezers with low temperatures of minus 80 degrees Centrigrade, but can be kept in minus 20 degress Centigrade using dry ice, making it more convenient for laboratories conducting testing in semi-urban and rural areas.

"This facility will be instrumental in ensuring access to affordable testing kits while maintaining global quality standards,” Chopra said.

Chopra declined to disclose the price of the test kit, but said it is priced competitively. The kits are packaged in a user- friendly and convenient pack size of 200 reactions. The company said it will make these kits available across the country leveraging its strong distribution network.

Surplus capacities
The prices of RT-PCR test kits, which were sold at retail market price of Rs 1,200 in March-April of 2020, have crashed to around Rs 200, with rise in competition and huge expansion of capacities undertaken by global raw material suppliers that led to drop in prices of enzymes and reagents

On the question of whether there is enough demand for RT-PCR test kits in India, with the declining trend of COVID-19 cases. Chopra said the pandemic is far from over.

"When we look at the experience in other markets and other countries, as we go forward, as we start bringing our population back to work, asymptomatic testing will become increasingly important part of protocols, we do believe that testing will remain with for sometime to come.

"When we make investment, these are long term investments, our capabilities are in molecular diagnostics so, while we are starting with COVID-19 test kit, as you look at the future, there would be many more technologies and innovations that we will bring to India, which will serve the needs of the country for other infectious diseases as well, this will be the capability that we have invested keep long term in mind," Chopra said.

Chopra said the Bengaluru facility will cater to the India market, but at a later stage the company may evaluate possibilities of exporting the kits. Currently, Thermo Fisher imports test kits from its manufacturing facilities in US.

Chopra said the company is planning to bring India - saliva based RT-PCR test kit, which is already in use in US.

With global sales of exceeding $30 billion, Thermo Fisher considers India as an important market. The company that has product and services catering to the entire gamut of lifesciences and medical value chain, invested about $125 million over last one decade for setting up manufacturing, distribution and back-end infrastructure in India.