Co-Diagnostics's India JV CoSara Diagnostics Completes Its Clinical Performance Study Of The CoSara PCR Mycobacterium Tuberculosis Test On CoSara PCR Pro Instrument; Has Submitted Test To India's Central Drugs Standard Control Organization For Regulatory Clearance

The submission follows the Company's July 22, 2026 announcement that CoSara had initiated clinical studies for the CoSara PCR MTB test across select laboratories in India. The clinical study assessed 676 clinical samples, including 233 paired with MGIT testing that formed the basis of the reported comparative performance results. The evaluation represents an important milestone supporting CoSara's CDSCO submission and advancing the CoSara PCR MTB test toward potential commercial launch in India.

The clinical evaluation was conducted in India in accordance with the applicable study requirements and resulting documentation forms part of the regulatory submission. The application is now subject to review by CDSCO, including any additional requirements that may arise during the regulatory process. Across three test batches evaluated during the clinical study, the CoSara PCR MTB test demonstrated an average sensitivity of 97.3% and an average specificity of 96.0% against the reference standard for TB detection, with highly consistent performance across batches.

India accounts for approximately one quarter of the world's tuberculosis cases, the highest burden of any country, according to the World Health Organization's Global Tuberculosis Report 2025, making it one of the most strategically important markets for the Company's mission of closing critical gaps in access to high-quality PCR testing. The CoSara PCR Pro instrument, the CoSara-branded version of the Co-Dx™ PCR Pro point-of-care instrument, leverages the Company's patented Co-Primers® technology to deliver rapid real-time PCR results in roughly 30 minutes via a mobile application, without the need for centralized laboratory infrastructure.

Supporting the platform's anticipated commercial launch, Co-Dx has also deployed its integrated mobile and cloud infrastructure in India, establishing a localized system for test analysis and secure data management. The architecture enables the platform's mobile application to generate test results in decentralized settings without continuous internet connectivity, with test data synchronized to the cloud when connectivity is restored.

"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," said 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."

Mr. Egan continued, "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."

The Company and CoSara currently expect regulatory approval of the CoSara PCR MTB test in the fourth quarter of 2026, which would position CoSara to begin commercial sales of the test in India before year-end. CoSara has been actively preparing for the commercial launch of the test through extensive planning and market development efforts, positioning the joint venture to move quickly upon regulatory clearance. Upon receipt of CDSCO clearance, CoSara plans to initiate sales activities across India and parts of South Asia, supported by CoSara's direct sales team, distributors, product demonstrations and customer outreach in targeted markets.