Kits For Asymptomatic Patients

Seagull BioSolutions, a startup working on new biological technologies, may become the first government-funded company to begin work on a vaccine for Covid-19, as the Department of Science and Technology has confirmed that the firm is being funded to undertake development of vaccine based on its Active Virosome (AV) platform.The firm is producing two types of AV agents — an AV expressing S-Protein of the SARS-CoV-2, which is called AV-S; and another one expressing structural proteins of the virus, called AV-SPs.Vishwas D Joshi, MD, Seagull BioSolutions told TOI: “This is a proprietary technology developed indigenously. It is basically nano molecules that can be customised to express any protein. We’ve tested it to produce proteins in other kinds of viruses in the past and are now working on SARS-CoV-2.”The company is currently amplifying the synthesis of both these agents upto 5mg levels so that their immunogenicity can be tested. “This test will first be performed in wild type mice to ascertain the ability of AV-S and AV-SPs to induce anti-Covid-19 T-cells and antibodies (including neutralizing antibodies),” the DST said.Once this is proven, they will undertake efficacy studies in a specific type of mice which are used as a model for SARS disease. In parallel, a bioprocess for production of AV-agent will be established and the AV-agent produced in large scale, about 1 lakh vaccine doses.“A detailed toxicity, safety and pharmacokinetic study will be performed in mice and another small animal species or monkeys and then the AV-vaccine agent will be prepared for Phase I clinical trials,” the DST said, adding that given the emergency situation, the firm aims to complete the proof of concept in 80 days and finish preclinical development and start Phase I trial by the end of 18-20 months.Further, the firm, based out of Entrepreneurship Development Center (Venture Center), Pune and supported by the National Science and Technology Entrepreneurship Development Board (NSTEDB) of DST is also developing special diagnostic kits for Covid-19.“The AV expressing S-Protein will be used as an antigen for this purpose. IgM capture ELISA kits, IgG type antibody detection ELISA kits and Lateral flow (LFA) immunodiagnostic kits are three types of assays the firm will be producing. LFA tests will empower individuals to test themselves easily and ensure that they remain disease free,” the DST said.Polymerase chain reaction (PCR)-based diagnostic kits which are currently available in India are rapid and enable detection of active infection but cannot identify asymptomatic infections or those people who were exposed to or infected with Covid-19 in the past and did not suffer from the disease or have recovered from it and may still be spreading the virus.“...In contrast, immunodiagnostic kits can help detection of these infections also. Therefore, the firm has initiated efforts to produce Immunodiagnostic kits for Covid-19. These tests will enable healthcare researchers to monitor the spread of Covid-19 more accurately,” DST added.The firm expects the Immunodiagnostic kits to be ready for field trials by the end of August 2020 and approved by the end of 10-11 months.