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May 21, 2021

Mylab secures approval for first Covid-19 self-test in India

The ICMR approves Mylab Discovery Solutions’ self-use rapid antigen Covid-19 test, CoviSelf, in India.

The Indian Council of Medical Research (ICMR) has approved domestic molecular biology company, Mylab Discovery Solutions’ rapid antigen Covid-19 test, CoviSelf, for self-use.

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This is the first Covid-19 self-test approved in the country. According to the ICMR guidelines, CoviSelf can be used to test symptomatic people and direct contacts of confirmed cases.

Each kit will consist of testing materials, a leaflet with usage instructions and a biohazard bag for safe disposal.

The test can be used with a nasal swab, which is expected to lessen the discomfort in comparison to the deep nasopharyngeal swab. Furthermore, the sample can be self-collected without needing the assistance of a healthcare expert.

The test, which is priced at $3.43 (Rs250) in the Indian market, can provide the result in 15 minutes. It is available for over-the-counter use and does not require a prescription.

Mylab Discovery Solutions director Sujit Jain said: “This easy-to-use test combines with Myab’s AI-powered mobile app so that a user can know his/her positive status, submit the result to ICMR directly for traceability and know what to do next in either case of result.”

Currently, the company has a production capacity of seven million tests a week and it intends to scale up the capacity to ten million tests per week in 14 days.

In a separate development, Indian company Cipla has launched a real-time polymerase chain reaction (RT-PCR) test called ViraGen for Covid-19 testing in the country.

The test is indicated for qualitative identification of nucleic acid from SARS-CoV-2 in the upper and lower respiratory samples obtained from people suspected of having Covid-19.

Based on multiplex PCR technology, ViraGen can detect the SARS CoV-2 N gene and open reading frame (ORF) lab gene.

It has received approval from the ICMR and has 98.6% sensitivity and 98.8% specificity as against a traditional ICMR test.

Cipla noted that Ubio Biotechnology Systems will produce the test, which will be commercialised and distributed by Cipla using its distribution network in the country.

Cipla managing director and global CEO Umang Vohra said: “Cipla has been working relentlessly to ensure accessibility to treatments in this fight against Covid-19.

“Guided by our core purpose of ‘Caring for Life’, this partnership will enable us to reach out to more people across the country at a crucial time like now.”

The supply of the Covid-19 test kit will start next week, the company noted.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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