Bio Spectrum|May 2020
The unprecedented COVID-19 pandemic has thrown a new set of challenges and opportunities to the entire world. This pandemic is a wakeup call on how fast a contagion can spread in a globalised world and the damage it could do to a civilization. The spillover effects of COVID-19 are seeping into a multitude of industries, by disrupting supply chains and crippling many business sectors globally.
It has not only posed a risk to the health of people but has also brought forward an imminent threat to the health of economies across the globe. Although the number of cases in India are far less than some of the majorly affected countries, India is no exception to the current exigency.
The government along with the industry is exploring every other possibility to combat this pandemic whether in the form of vaccines, drugs, diagnostic tests, medical equipment or therapeutic interventions. The major objective is to develop a long term solution by pooling proper resources, sharing knowledge and collaboration.
“The Central Government has provisioned Rs 15000 crore for treating coronavirus patients and strengthening the medical infrastructure of the country. This will allow for rapidly ramping up the number of corona testing facilities, Personal Protective Equipment (PPE), isolation beds, ICU beds, ventilators and other essential equipment. Simultaneously, training of medical and paramedical manpower will also be undertaken. I have requested the State Governments to ensure that only healthcare is treated as their first and topmost priority now,” states Prime Minister Narendra Modi.
In response to the growing COVID-19 pandemic, the scientific community and the industry are developing rapid and easy-to-use diagnostic devices. One such example is of ChitraGeneLAMP-N test developed by Thiruvananthapuram based Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST). The confirmatory diagnostic test, which detects the N Gene of SARS- CoV-2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP), is one of the world’s first few if not the first of its kinds in the world.
The test kit, funded by the Department of Science & Technology (DST) is highly specific for SARS-CoV-2 N-gene and can detect two regions of the gene, which will ensure that the test does not fail even if one region of the viral gene undergoes mutation during its current spread. The detection time is 10 minutes, and the sample to result time is less than 2 hours.
Similarly, Pune based startup FastSense Diagnostics has rolled out a modified polymerase chain reaction (PCR) based detection kit for confirmatory analysis in lesser time compared to existing detection methods. The kit can test approximately 50 samples in an hour. The startup has also developed a portable chip-based module for rapid screening of target population based on the on-chip sensing technology that can provide on the spot results in less than 15 minutes per sample. The sample size for confirmatory tests can also be increased in the future to 100 samples/ hour.
Now although Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) based assay is a highly sensitive test for detecting SARS-CoV-2, it has its limitations. The test can be used for early diagnosis of the disease but the situation today demands surveillance along with diagnosis.
As a result, the attention has now shifted to serological immunoassays that detect viral-specific antibodies (IgM and IgG) or antigens. These serological assays can be tested on seemingly healthy people who may have been infected with COVID-19 in the past but recovered without showing any symptoms. This is done by measuring the amount of antibodies from their blood samples.
Till date, 16 antibody-based rapid tests for COVID-19 have been validated at the Indian Council of Medical Research- National Institute of Virology (NIV) Pune, and 13 have been found to be satisfactory.
Understanding this need of the hour, Module Innovations, based in Pune, is currently developing a testing device called nCoVSENSe for detection of antibodies that have been generated against the COVID-19 in the human body. The test is aimed at detecting the IgG and IgM antibodies generated in the human body upon the onset of viral infection and is targeted against the spike proteins making it specific for COVID-19. The startup is planning to deploy the test in a time of 2 months after due validation with national agencies.
“Upon infection with the SARS-CoV-2 virus, the patient’s immune system tries to fight the virus by producing blood-circulating molecules known as antibodies. IgM is a class of antibodies that appears early after an infection (as early as 3-5 days). IgG is another class of antibodies that appears later and gradually replaces the IgM antibodies. Usually, IgG antibodies appear in the blood circulation after 7-10 days of the exposure. The presence of SARS-CoV-2- specific IgM and/or IgG antibodies in the blood of a patient is a strong indication that the patient has been infected with the SARS-CoV-2 virus”, explains Sachin Dubey, CEO & Co-Founder, Module Innovations, Pune.
Another startup in Pune, Seagull BioSolutions based out of Entrepreneurship Development Center (Venture Center) and supported under the Seed Support System of the Technology Development Board (TDB), DST, is developing immunodiagnostic kits- IgM capturing ELISA kits, IgG type antibody detecting ELISA kits, and a Lateral flow (LFA) immunodiagnostic test, for COVID-19 detection. The startup expects the immunodiagnostic kits to be ready for field trials by the end of August 2020.
Amongst the many other attempts being made by the industry in the diagnostic space, Bengaluru based startup Bione has developed a rapid COVID-19 at-home screening test kit which is an IgG & IgM based tool which takes 5-10 minutes to deliver the results. The kit is approved by the Indian Council of Medical Research(ICMR) and will be deployed in the market after proper quality checks and assurance.
More than 60 candidate vaccines are currently in development, worldwide, and several have entered early clinical trials in human volunteers, according to the World Health Organization (WHO). Few Indian companies have also joined this fight by opting for innovative approaches.
Pune based Serum Institute of India (SII) and Ahmedabad based ZydusCadila were the first to announce their plans for developing vaccine candidates against COVID-19. At present, the Department of Biotechnology (DBT) is providing funding support to SII to carry out Phase III human clinical trials study of recombinant BCG vaccine (VPM1002) for COVID-19 treatment. Cadila Healthcare has also received support from DBT for advancing the development of its DNA Vaccine candidate.
A recent announcement in this space came from Hyderabad based company Bharat Biotech for the development of a novel nasal vaccine. The unique intranasal vaccine called CoroFlu is under development with an international collaboration of virologists at the University of Wisconsin–Madison and the vaccine company FluGen in the US.
“We will manufacture the vaccine, conduct clinical trials, and prepare to produce almost 300 million doses of vaccine for global distribution. Under the collaboration agreement, FluGen will transfer its existing manufacturing processes to Bharat Biotech to enable the company to scale up production and produce the vaccine for clinical trials”, shares Dr Raches Ella, Head of Business Development, Bharat Biotech, Hyderabad.
In collaboration with US-based Akers Biosciences, Gurugram based Premas Biotech has also stepped into the process of vaccine development to tackle this outbreak. Premas is utilizing its D-Crypt platform to recombinantly express the major structural proteins of the coronavirus. Based on genetically engineered baker’s yeast S. cerevisiae, D-Crypt is highly scalable into commercial production quantities.
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