CoSara Diagnostics Oligonucleotide Synthesis Facility Grand Opening
On December 11, 2024, Co-Dx and CoSara Diagnostics Pvt Ltd, our joint venture in India, were pleased to officially inaugurate CoSara’s oligonucleotide synthesis facility in Ranoli, India, designed to manufacture our patented Co-Primers® oligos in-house. This facility is the first of its kind in the state of Gujarat, and will support the “Make in India” initiative. Qualifying under this initiative is anticipated to facilitate access to India’s large and growing healthcare marketplace as we prepare to seek regulatory approval and a commercial launch of the Co-Dx PCR Pro™ instrument and test cups for illnesses including tuberculosis (TB) and human papillomavirus (HPV). Co-Primers provide the “molecular miracle” that powers the test cups for the new platform, as well as the centralized lab-based tests manufactured and sold by Co-Dx and CoSara. The event was well-attended by representatives from NGOs, district TB officials, and healthcare key opinion leaders.
Make in India and the Indian Healthcare Marketplace
In 2014, India found itself on the brink of severe economic crisis. In response to a falling growth rate and concerns of global investors whether India was an investment risk rather than an opportunity, the Make in India initiative was launched in September 2014 to galvanize the country’s citizens and leaders and to turn around the Indian economy. It represented a shift in the government’s mindset, from issuing authority to business partner, as obstructive frameworks were replaced with more transparent, user-friendly systems.
The call to “Come, Make in India!” extended an invitation to potential partners and investors around the world to make India an integral part of the global supply chain, and the preferred global manufacturing destination. These changes included incentives for investments into manufacturing, and for companies to develop, manufacture and assemble products in India, as opposed to importing them. Participating in the Make in India initiative using dedicated manufacturing facilities built to suit for Co-Dx chemistry (and ultimately the Co-Dx PCR platform itself) not only helps to support the revitalized Indian economy, it also carries cost-saving advantages over exporting to India.
CoSara Diagnostics Pvt Ltd
The Indian healthcare market is advanced, sophisticated, and has grown along with the population. Introducing state-of-the-art technology into this high-tech marketplace can be a complex endeavor. This was a driving reason for partnering with Synbiotics, Ltd to form CoSara in 2017. Synbiotics is a group company of Asence Inc., a U.S. incorporated company that specializes in supplying pharmaceutical products to international markets across 35 countries. Both Asence and Synbiotics are subsidiaries of Ambalal Sarabhai Enterprises Ltd., a continuation of one of the oldest and most respected Indian manufacturing institutions in operation today.
The first CoSara facility was designed to manufacture high-throughput clinical laboratory PCR tests built on the Co-Primers platform and sold under the Saragene™ brand. The facility was inaugurated in April 2019, with IVD clearances for the first 5 PCR tests received from the Indian Central Drug Standard Control Organization (“CDSCO”) later that year. Since that time, clearances have been granted for 10 more PCR tests for a total of 15 to date as CoSara has expanded its footprint and recognition and completed the build-out of the new facility inaugurated on December 11.
We anticipate that the first tests on the new platform to be introduced to the Indian market will be tests for TB and HPV. The WHO reported that 10.8 million people fell ill from TB in 2023—26% of which were in India. The estimated 1.25 million deaths worldwide in 2023 indicate that TB has likely replaced COVID-19 as the world’s leading cause of death from a single infectious agent.
Management’s Remarks
“We are greatly pleased with the results of this growth stage as we look towards the future, which is expected to include additional facility expansion for manufacturing the Co-Dx PCR Pro instrument and the test cups for illnesses like TB, HPV and more, as we scale to meet the needs of the most populous country in the world,” remarked Mohal Sarabhai, CEO of CoSara. “India is home to some of the world’s best and brightest scientists, researchers and medical professionals who we believe will recognize the value of the Co-Primers PCR technology and of the forthcoming testing platform.”
Co-Dx CEO Dwight Egan added “This event is an important milestone in our Company’s journey to close the infectious disease diagnostics gap worldwide, and in our story coming full circle. The new facility and the grantors who helped to fund it provide tangible evidence of the Company’s foresight that partnering with Synbiotics Ltd in 2017 to form CoSara would help lay the groundwork for introducing state-of-the-art Co-Dx technology to India’s high-tech healthcare marketplace. We believe that synthesizing Co-Primers in-house will play a vital role in enhancing manufacturing efficiency and removing barriers as we move towards regulatory approval and commercialization of our new PCR testing platform in India. We are grateful for our invaluable partners in these efforts, whose hard work has helped to bring this facility online.”
