Mylab Collaborates With Syngene
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Mylab Collaborates With Syngene

In order to further India’s self-reliance in testing and in a bid to scale up production and escalate faster delivery of Covid-19 testing kits, Mylab Discovery Solutions, the Pune-based molecular diagnostics company, has collaborated with the research arm of India’s leading bio-pharmaceuticals firm Biocon, Syngene International.

The company took to Twitter to make this announcement,

Adar Poonawalla, Serum Institute India’s CEO expressed his view, commenting on the development.

For the expansion of molecular diagnostic solutions and to scale up production of COVID-19 testing kits, Mylab Solutions had inked a deal with Serum earlier this month.

In a record time of six weeks, the first company to develop Made-in-India test kits for Covid-19 was Mylab. Indian FDA/Central Drugs Standard Control Organisation (CDSCO) approved their kit, the Mylab PathoDetect COVID-19 Qualitative PCR kit, and this is the first kit to get commercial approval from the organization. Moreover, 100 percent sensitivity and specificity in the ICMR evaluation was achieved, and Mylab is the

only Indian company to have achieved this.

In producing Real-Time PCR kits, Mylab has several years of experience. A wide range of kits is manufactured by them. For manufacturing medical devices of Class C and D, the most stringent and regulated products by the government, it is compliant with MDR 2017 regulation and the facility is approved by Indian FDA/CDSCO. Currently, ID-NAT screening kits are being manufactured by Mylab for blood banks/hospitals, also manufactures Quantitative HCV, HBV, and HIV kits. In the same facility,  the Drugs Controller General of India (DCGI) has given clearance to Mylab to manufacture the COVID-19 Qualitative kit.

Source

Mylab Collaborates With Syngene

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