Virologist Minal Dakhave Bhosale from Pune had headed the designing team for the corona virus testing kit called ‘Mylab PathoDetect COVID-19 Qualitative PCR kit’.She is the research and development chief of Mylab Discovery Solutions in Pune, the first Indian company has received full approval to make and sell Covid-19 testing kits.Key Points:
i.Mylab Discovery Solutions , Pune-based molecular diagnostics company had created a history by developing the first made in India for Covid-19 diagnostic test kits (also known as the Reverse transcription polymerase chain reaction (RT-PCR) tests) in a six weeks of time period.
ii.This became the first kit which obtained a commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is named as’ Mylab PathoDetect COVID-19 Qualitative PCR kit’. Also Germany’s Altona Diagnostics is other company to get the approval for same.
iii.Mylab has received clearance from Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit. The Mylab COVID-19 kit has been evaluated at Indian Council of Medical Research (ICMR).
iv.‘Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to 7+ hours taken by current protocols and Mylab could manufacture up to 1 lakh test kits in a week.
v.Minal Dakhave Bhosale submitted the complete design of the kit a day before giving birth to her daughter.
Motive behind the invention:
India is currently testing 6.8 per million populations which considered as lowest compared to other countries in this difficult circumstance. Indian government is receiving millions of testing kits from Germany to diagnose Corona virus patients.
Additional Info about Mylab
Mylab has an experience of several years in 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. Mylab currently manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits.