Co-Diagnostics' Joint Venture CoSara Diagnostics Completes Clinical Study and Regulatory Submission for Point-of-Care Tuberculosis Test, Sets Stage for Commercial Launch in India

Dwight Egan, Chief Executive Officer of Co-Diagnostics

“Completing this clinical study and submitting to the CDSCO is a defining milestone for our India program and a significant execution achievement for Co-Diagnostics,”

Dwight Egan, Chief Executive Officer of Co-Diagnostics

“Since forming CoSara in 2017, we have invested in building the manufacturing, regulatory and commercial infrastructure needed to bring affordable, decentralized molecular TB testing to the country with the largest tuberculosis burden in the world. With our integrated mobile and cloud infrastructure now deployed in India, we have also established the digital foundation needed to support testing, secure data management and future commercial operations across decentralized healthcare settings.”

Dwight Egan, Chief Executive Officer of Co-Diagnostics

“We are extremely pleased with the results of this study. The strength and consistency of the test's clinical performance reflects both the capabilities of our Co-Primers® technology and the readiness of CoSara's manufacturing operations as we prepare for launch. Our team has spent more than three years preparing to bring this test to market, and with this submission complete, we are entering the next phase of our India strategy and are positioned to move quickly from regulatory review to commercial launch, which we expect to begin in India before the end of this year. Together with our FDA 510(k) submission in August, we now have two major regulatory submissions under review in two of the most important markets for our platform.”