The first batch of 150 kits was rolled out to diagnostic labs in Pune, Mumbai, Delhi, Goa and Bengaluru. (Representational Photo)
Minal Dakhave Bhosale, a 33-year-old virologist who worked at the National Institute of Virology during the 2009 H1N1 pandemic, now heads the research and development section at the Pune-based Mylab Discovery Solutions the first Indian firm to have obtained approval from the ICMR and Indian FDA/Central Drugs Standard Control Organisation to make and sell test kits for COVID-19. She spoke to The Indian Express.
Please explain what the PathoDetect COVID-19 test is?
This is an in-vitro diagnostic test based on real time PCR technology for the detection of 2019- novel coronavirus nucleic acid in the respiratory symptoms and sera. The test follows the WHO/CDC guidelines of development. Detection is based on the amplification of gene-specific conserved RNA sequences of coronavirus and detection by hydrolysis probe based chemistry.
How long did it take to design primers and from where were the materials obtained?
Considering the emergency situation, the test design was completed in a day or two... The major effort for COVID-19 test development was put in by our lab team in Pune Our team was working for 14-16 hours to ensure fast receipt. There was no shortage of raw material and manufacturers have been identified domestically. Kit development was completed in a record time of 6 weeks with required government approvals. It was submitted for evaluation on March 18 at NIV and we got the license on March 23. The government-run Indian Council for Medical Research (ICMR), under which NIV operates, approved the testing kit, confirming that Mylab was the only Indian company to achieve 100 per cent results at that time. Since it is a national emergency, FDA/CDSCO took our application on a fast-track mode.
What is the manufacturing capacity and how soon can you scale it up?
Our R&D facility is at Baner in Pune while the manufacturing facility is at Lonavala. We want to bring technology in a simple way. The PathoDetect COVID19 test will accelerate the coronavirus diagnosis speed and clinical management. We can manufacture around 1-1.5 lakh tests in a week which can be further scaled up twofold in a week’s time if needed.
Testing time is 2.5 hours. What is the cost?
The first batch of 150 kits was rolled out to diagnostic labs in Pune, Mumbai, Delhi, Goa and Bengaluru. We are committed to providing reliable and easy-to-use solutions, services, and support to meet the needs of molecular diagnostics laboratories. Our focus is to bring up quality diagnostic tests to reduce testing time and with a cost-effective manner. The current government protocol involves screening and confirmation of samples which takes 6-7 hours whereas our COVID-19 test includes a single test for both screening and confirmation along with unique reagent formulations, thus reducing the time of detection to 2.5 hours. The made in India test kit will cost Rs 1,200.
What are the other tests designed and manufactured?
Mylab currently manufactures RT PCR based kits for ID-NAT screening for blood banks/hospitals, Quantitative HIV, HBV and HCV. Mylab is the first company in Asia and second in the world to manufacture RT PCR-based ID-NAT kits.