HQ Team
March 29, 2023: India’s Technology Development Board has signed a pact with Huwel Lifesciences for the validation and commercialisation of rapid real-time PCR reagents for storage and transport at room temperature.
The body, which comes under the government’s Department of Science and Technology, has cleared INR 50 million in financial support for the project, which is estimated to cost INR 400 million, according to a government statement.
The COVID-19 pandemic has changed the perspective of molecular testing, according to a government statement. RT-PCR has been the gold standard for COVID-19 testing globally, and the RT-PCR machine has reached district-level hospitals in India.
As a load of COVID-19 testing has come down significantly, these machines can now be put to use in screening various infections, cancers and genetic diseases other than COVID-19.
“However, current RT-PCR reagents need to be transported and stored at sub-zero (-20) temperatures. Owing to the varied climatic and socio-economic conditions (in India), it is a challenging task for shipping and storage in tier 2 & tier 3 towns.
High transportation costs
The cost of dry ice shipping and improper storage has been hampering the implementation of RT-PCR testing for disease diagnosis,” according to the statement.
To overcome the above difficulty, TDB has extended financial assistance to the company Huwel Lifesciences, which has developed room-temperature stable RT-PCR reagents with rapid RT-PCR completed in about 35 minutes.
Polymerase chain reaction tests or PCR tests are a type of nucleic test used to detect the presence of the genetic material of the SARS-CoV-2 virus that causes COVID-19. Reagents are substances used to carry out laboratory tests or can be used in a chemical reaction to detect, measure or make other substances.
Huwel Lifesciences Pvt. Ltd. was established in February 2015 and develops molecular diagnostics kits which enable reference labs and hospitals to provide reliable and high-quality diagnostics services.
The company’s facility, situated in Telangana state in southern India, makes PCR, real-time PCR kits and rapid real-time PCR machines with reagents. Real-time RT-PCR is a platform technology used in the amplification of DNA and RNA and its detection on a real-time basis.
FDA, CE compliant
The facility is CE or meets European standards in the European Economic Area, USFDA and is EU’s MDR-compliant. It has a manufacturing capacity of over 100 million PCR tests per annum and scale-up capabilities.
Huwel has an in-vitro diagnostic device manufacturing licence for manufacturing and marketing a wide range of molecular diagnostic kits covering infectious diseases, cancer markers and genetic disorders.
The company has catered for the highest number of COVID kits for most of the states in India through government tenders, and its products are approved in UAE and the Philippines.
The reagents can be transported and stored at room temperature and are economical and easy to use. It is suitable for field testing and can test multiple diseases on any open platform RT-PCR machines, according to the government.
“Moreover, the kit holds great market potential, as it may open up a large segment of markets in tier 2 and tier 3 towns and reduce shipment costs significantly.”
CGMP facility
Huwel aims to set up a CGMP manufacturing facility (to follow FDA regulations) to produce PCR reagents stabilised at room temperature and also RT-PCR kits using such reagents both for the domestic and international markets.
“Our approach at Technology Development Board has always been to support technologies that have the ability to improve upon the existing process in a cost-effective way thereby making it more accessible to the common man,” said Rajesh Kumar Pathak, Secretary of the board.
“Huwel Lifesciences has come up with a similar innovation that has the ability to transform the existing practice of transporting and storage of current RT-PCR reagents at sub-zero (-20 degrees) temperature to room temperature, thereby making it reasonable, cost-effective and accessible to the masses in tier 2 and 3 cities,” he said.
