Coviself
M/s Mylab Discovery Solutions Private Limited, Pune Maharashtra

Technology Development Board (TDB) has entered into an agreement with M/s Mylab Discovery Solutions Pvt Ltd for the project on 'Manufacturing of Testing Kits to detect COVID Corona Virus' and received a grant assistance of Rs. 4 crore against the total project cost of Rs. 13.6 crore.

About the Technology
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Currently, most pandemic-prone diseases, including coronavirus, are diagnosed accurately by polymerase chain reaction (PCR) only, a molecular technique that is the gold standard in diagnostics, and is also recommended by CDC. The PathoDetectTM COVID-19 detection kit has been developed and deployed implementing a robust diagnostic methodology for use in public health laboratory settings for the screening and detection of COVID-19. The company has developed a validated diagnostic workflow for the same. The workflow reliably detects COVID-19, and further discriminates COVID-19 simultaneously within 2.5 hours compared to 7 hours+ required by other protocols. PathoCatch COVID-19 Ag Card test is used for in vitro qualitative detection of the antigen of novel Coronavirus in human throat swabs or nasal swabs. This rapid kit for testing COVID-19 virus can be used with samples from throat or nasal swabs and gives results in 20 minutes. The test is a Point of Care test and has the best performance characteristics in ICMR evaluation. The company has recently developed a home testing kit called “COVISELF”, India’s first self-test kit that has been approved by ICMR and the production of the same is being ramped up for commercialization.

 

Commercialisation of the Product
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This project was undertaken in Lonavala, Maharashtra. The company offers a broad range of complete high quality, CE-IVD marked real-time PCR kits with ISO13485 manufacturing standards, produced in WHO – cGMP compliant facility. Each reagent represents the level of quality required when developing tests for the clinical market. The company mainly uses in-house technology. The products were commercialised in 2020. A total revenue of Rs. 8.4 crore has been generated in the year of commercialization and subsequent year itself. A total of 39 lakh RT-PCR tests have been sold till date.

Impact of funding
success
Coviself / RT-PCR & Antigen developed by Mylab Discovery Solutions have outreach in almost all Indian states, and also got international recognition, including in Africa.