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A generic step-wise isothermal nucleic acid-based testing technology for the rapid diagnostics of pathogenic infections including but not limited to SARS-CoV-2 in individuals.
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Nasal Swab/ Saliva to result from integration in about 45 minutes in a highly affordable pre-programmable portable device developed by the team, without requiring any separate facility for RNA extraction.
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Kit supplemented with a free smartphone app to facilitate unambiguous results interpretation and automated dissemination to the patients. The test may be performed by unskilled personnel outside the controlled lab with no intermediate manual intervention between sample loading and result dissemination.
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Patents filed in the India, USA, several other countries, and the foreign filing license has been granted recently.
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The unique trade-off between the high scientific standards of advanced molecular diagnostics with the elegance of common rapid tests for underserved community care.
Kharagpur, India, IIT Kharagpur has successfully commercialized its flagship healthcare product – COVIRAP – the novel diagnostic technology for infectious diseases including COVID-19 and beyond. The product developed by lead researchers Professor Suman Chakraborty, Dr. Arindam Mondal and their research group has been licensed for commercialization to the Rapid Diagnostic Group of Companies, India and Bramerton Holdings LLC, USA.
Bramerton Holdings has signed a record deal for securing global rights for commercially disseminating the COVIRAP technology developed at IIT Kharagpur in various geographical locations outside the territory of the Indian subcontinent. Rapid Diagnostic has also initiated adapting the COVIRAP technology platform for COVID-19 and tuberculosis, in collaboration with IIT Kharagpur.
The research team has now developed a more advanced version of COVIRAP using a step-wise isothermal nucleic acid testing technology for the rapid diagnostics of pathogenic infections including SARS-CoV-2 in individuals. The COVID-19 diagnostic test can be conducted directly from human swab samples in the portable device developed by the team, without requiring any separate facility for RNA extraction. The results can be made available within 45 minutes of obtaining the patient sample. The kit has also been also supplemented with a free smartphone app to facilitate unambiguous results interpretation and automated dissemination to the patients.
Recognizing the impact of the COVIRAP technology in meeting the long-standing demands of high-quality community-level testing, IIT Kharagpur has further initiated the procedure of deploying this product for on-campus use to detect possible novel coronavirus infection.
“The above move has taken place at a critical juncture when the recent spurt in COVID-19 infection, commonly known as the second wave, has been threatening to spread more rapidly than ever before. Moreover, the commercialization of COVIRAP will initiate complete indigenization and availability of a large range of affordable healthcare products in the Indian market as well as deep trenches of a large global market that is literally starving for the need of such technology. COVIRAP promises its reach to the grass-root level in catering to the needs of the last person of the society,” opined Director Prof. V K Tewari.
For use of the test, the nasal, as well as oral swab samples, are diluted in a solution and tested in the portable device by mixing with reagents that are supplied in a pre-mixed form. The test runs automatically in the device without intermediate manual intervention.
“We have conducted field trials for running the tests with the help of unskilled personnel outside controlled laboratory ambiance, with no compromise in quality of the test outcome. The entire sample-to-result procedure may be conducted in the portable device, virtually anywhere and with minimal training thus making the process of testing more effective for community-level screening and early detection of any emerging infection outbreak. This may act as a key to arrest community level spreading of the infection,” remarked Prof. Suman Chakraborty.
Nucleic acid-based point-of-care tests such as COVIRAP usher great promises as viable alternatives for rapid testing of pathogenic infections at low cost in resource-limited settings.
“The COVIRAP test overcomes several potential bottlenecks faced by similar other tests in the past, for instance, poor performance outside highly controlled laboratory and lack of simple, affordable, yet generic and universal instrument that may be used for home-based testing and community healthcare for a wide variety of infectious and non-infectious diseases,” he explained.
Patents centered around this innovation have been filed in the India, USA, several other countries, in the name of IIT Kharagpur. The foreign filing license has been granted recently. Commercialization and use in the USA and Europe under the Emergency Use Authorization (EUA) process are currently underway. Both the Rapid Diagnostic Group in India and Bramerton Holdings in the USA, in association with IIT Kharagpur, have already identified the key resources towards establishing the reagent supply chain, kit and device manufacturing in entirety under a ‘Make in India’ initiative with complete import substitution. In addition to licensing COVIRAP to these companies, the inventors at IIT Kharagpur will receive further support via industrial consultancy project mode for further advancement of the product.
The envisaged trade-off between the high scientific standards of advanced molecular diagnostics with the elegance of common rapid tests appears to be the future of infectious disease detection and management. A platform technology capable to be inclusive of all such disease detections where nucleic acid-based tests may be deployed, COVIRAP is not just a one-time solution targeted specifically to COVID-19 but will remain imperative in global disease management overall years to come.
About COVIRAP Commercial Partners:
Rapid Diagnostic Group of Companies: Founded by Dr. Bharat Jindal, a medical doctor by profession, the companies were established in 1995 with the sole aim of providing quality and leading-edge products and services to the Indian Healthcare ecosystem. By now, they have established an extensive national network of 22 offices and 4,000 distributors, enabling outreach to customers at under-resourced locations where the infrastructure of high-end diagnostic tests remains non-existent. In response to the pandemic situation, they came into the production of COVID IgG ELISA kits with a joint venture of ICMR/NIV, Rapid tests, PPE kits, Masks and few more products which can help the Nation. Boosted by their own manufacturing facility of diagnostic tests based in Delhi, they envision bringing the COVIRAP technology to the Indian Market at the earliest. As a pioneer in the industry, their mission is to provide timely, high-quality diagnostic kits, diagnostic instruments, point of care and critical care instruments at an affordable price. They have also initiated adapting the COVIRAP technology platform for TB diagnostics, in collaboration with IIT Kharagpur.
Bramerton Holdings: Bramerton Holdings is a subsidiary of Riverfort Global Capital (ww.riverfort.com). The Riverfort Group comprises a London-based investment advisor regulated by the UK Financial Conduct Authority and a number of regulated investment funds and investment companies. In addition, the Riverfort group is an investor in the Sure Vally Ventures (SVV) venture capital fund which invests in early-stage technology companies and includes both private sector and governmental investors. The Riverfort Group and its founders have arranged and advised the funding of over 100 companies deploying over 500 million USD in capital. Bramerton Holdings is launching the special purpose vehicle for the global development and distribution of the COVIRAP technology via its subsidiary called VeenaNxt
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