Pune based company develop coronavirus test kit

A Pune-based company, Mylab Discovery Solutions Pvt Lab, has developed India's first COVID-19 detection kit.

The molecular diagnostic company achieved the feat last week.

"At present, Mylab can produce kits to test 20,000 samples per day, but it can ramp up capacity to 20,000 kits," said Rahul Patil, Executive Director and Operations Head, Mylab Discovery Solutions.

Virologist Minal Dakhave Bhosale, Research & Development Head, Mylab Discovery Solutions, played a key role in the development of the kit.

In fact, she submitted the kit on 18 March, to the Pune-based National Institute of Virologist (NIV), for evaluation and clearance.

"It was like giving birth to two babies....it was an emergency and I took it up as a challenge," Bhosale was quoted saying. The kit has been approved by the Indian Council of Medical Research (ICMR).

For latest updates on coronavirus outbreak, click here

Niti Aayog CEO Amitabh Kant said it was a big achievement. "Inspirational! Delivered test kit before delivering her baby. Meet Minal Dakhave Bhosale, the R&D Chief of Mylab. She led the team that designed India's first indigenous #COVID19 testing kit. Who said women can't do well in #STEM," he tweeted.

Captains of India Inc like Anand Mahindra and Kiran Mazumdar-Shaw praised her on the achievement.

"Ms. Bhosale, you delivered not just the test kit and your baby, but you also delivered a ray of hope to the country. We stand and salute you," tweeted Mahindra.

"Coronavirus: The woman behind India's first testing kit - God bless you Minal Bhosale ⁦@MylabSolutions⁩," Shaw tweeted.

The kit is the first one to receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit. Mylab is the only Indian company to have achieved 100% sensitivity and 100% specificity in the ICMR evaluation.

Hasmukh Rawal, Managing Director, Mylab Discovery Solutions, said, “With an emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kit, has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time”. He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.

Mylab has an experience of several years in the manufacturing of RTPCR kits and manufactures a range of kits at the facility approved by Indian FDA/CDSCO and compliant with MDR 2017 regulation for manufacturing medical devices of Class C and D, the most stringent and regulated products by the government, Mylabcurrently manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits.

Apart from this, Mylab has received clearance from Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit, in the same facility.

The Mylab COVID-19 kit has been evaluated at the Indian Council of Medical Research (ICMR).

“We have been trying hard to make cutting edge technology available to our country at a reasonable and affordable price. Since this test is based on sensitive PCR technology, even early-stage infection can be detected, with the highest accuracy as has been seen during tests at ICMR.

The ICMR tested, CDSCO approved kit makes detection faster too”, said Mr. Shailendra Kawade, Executive Director, Mylab Discovery Solutions.