Agappe Diagnostics Ltd, a Kochi-based pharma company, entered into an agreement with SCTIMST to commercially manufacture RNA extraction kits. The launch of the kit at the national level will be held at a function in Delhi next week, the sources said.
“Lack of RNA extraction kits was a major reason for the low number of Covid-19 tests in the country. Currently, RNA extraction kits are imported. When competent agencies approve commercial production of the kits, it will solve the RNA extraction kits shortage problem,” sources said close to SCTIMST. “Since all components of the kit are originally manufactured, it will facilitate rapid production of RNA extraction kits on a large scale,” sources added.
“We are ready to produce large-scale RNA extraction kits as we have received all the approvals required for commercial manufacturing. We have already received inquiries from all over the country, ”said sources with Agappe Diagnostics.
The company plans to produce at least 1 lakh sets this month. From June onwards, 3 lakh sets will be produced every month, sources with the company said. “Currently, the cost of imported RNA extraction kits is around Rs 300 per day. PCS. When we start production, we will be able to deliver the kit at half the speed, ”the sources said.
Meanwhile, SCTIMST researchers are modifying LAMP-N, a kit developed by the institute as a cheaper, faster, and more accurate alternative to existing sets for RT-PCR testing. The technology has been transferred to Agappe Diagnostics and the company is ready for its commercial production. The Indian Council for Medical Research (ICMR), which is authorized to approve the production of the kits, proposed certain changes after the initial validation rounds. Once the kits produced by the private company have approved validation, the company can apply for a license from the Drugs Controller General of India, which is the final hub for commercial production of medicines and diagnostic kits.
When Chitra Gene LAMP-N is marketed, it can reduce the time and cost of diagonizing Covid-19. Currently, an RT-PCR test kit costs around Rs 4,500. Chitra Gen LAMP-N can be sold for around Rs 1,000 per day. Set, say sources with Agappe. The time required to generate results can also be significantly reduced.