In a bid to scale up production and escalate faster delivery of COVID-19 testing kits, Pune-based molecular diagnostics company Mylab Discovery Solutions has partnered with Syngene International, the research arm of India's leading bio-pharmaceuticals firm Biocon.
"India has led by example in its response to the COVID-19. To further India's self-reliance in testing, Mylab Solutions collaborates with Syngene International for Make in India raw materials," the company took to Twitter to announce today.
Commenting on the development, Serum Institute India's CEO Adar Poonawalla said, "Happy to have a partnership with Syngene, to make Mylab's COVID-19 test kit more indigenous; reducing its dependency on international raw materials and to further strengthen India's self-reliance in response to COVID-19."
India has led by example in its response to the #Covid_19. To further India's self-reliance in testing, @MylabSolutions collaborates with @SyngeneIntl for #MakeinIndia raw materials. @kiranshaw@adarpoonawallahttps://t.co/MN5CbtvuHf- Mylab Discovery Solutions (@MylabSolutions) April 24, 2020
Earlier this month, Mylab Solutions had inked a deal with Serum to scale up production of COVID-19 testing kits and expansion of molecular diagnostic solutions.
Mylab was the first company to develop Made-in-India test kits for COVID-19 in a record time of six weeks. The kit -- Mylab PathoDetect COVID-19 Qualitative PCR kit -- was the first one to receive commercial approval from the Indian FDA/Central Drugs Standard Control Organisation (CDSCO). Besides, Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation.
Mylab has several years of experience in manufacturing Real-Time PCR kits. It manufactures a range of kits at the facility approved by Indian FDA/CDSCO and is 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. Mylab has also received clearance from the Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit, in the same facility.