CRISPR Based Diagnostic Kit for Detection of Covid-19

Case Studies >>

Regulatory and Market Authorization Support for CRISPR Based Diagnostic Kit for Detection of Covid-19

During the height of the COVID-19 pandemic, a Premier CSIR Research Institute in India developed a unique diagnostic kit that utilized components of the bacterial CRISPR system to rapidly identify the presence of SARS-CoV-2 sequences in a patient’s sample. This innovative approach aimed to address the challenges posed by the widely used quantitative real-time PCR system, which requires expensive equipment and a skilled technical workforce to perform testing.

The CRISPR-based diagnostic kit offered a more accessible and cost-effective alternative, with the potential to expand testing capabilities and reach a wider population. However, bringing this novel technology to market posed challenges, particularly in navigating the regulatory landscape and ensuring swift approval and deployment.

The Research Institute partnered with an established company to commercialize the technology and sought Nextvel’s expertise in navigating the Indian regulatory landscape.

Nextvel prepared the entire dossier for regulatory submission and facilitated the rapid and expedited commercialization of the kit. Nextvel’s in-depth knowledge of the Indian regulatory system allowed us to identify and address potential hurdles proactively, minimizing delays in the approval process.

This swift action enabled the timely deployment of the kit, contributing to the country’s efforts to contain the spread of COVID-19. The successful commercialization of this novel diagnostic kit strengthened India’s response to the pandemic and showcased the country’s innovation and resilience in the face of a global health crisis.

By overcoming the challenges associated with traditional testing methods and navigating the complex regulatory landscape, this CRISPR-based diagnostic kit has the potential to revolutionize COVID-19 testing, making it more accessible, affordable, and widely available to communities in need.