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Co-Diagnostics Inc. CODX on Wednesday said CoSara Diagnostics Pvt. Ltd, its joint venture in India, is initiating clinical studies for the tuberculosis test on the CoSara PCR Pro instrument.
The molecular diagnostics company said the initiation of these clinical studies marks another critical milestone for the Co-Dx PCR platform, following the company’s previously announced shipment of PCR Pro instruments, mycobacterium tuberculosis (TB or MTB) test kits and proprietary sample preparation instruments to CoSara.
PCR Platform Delivers Results In About 30 Minutes
The decentralized point-of-care platform leverages patented Co-Primers technology to deliver rapid, gold-standard real-time PCR results in roughly 30 minutes via a mobile application.
CoSara is currently deploying the CoSara PCR Pro instrument, the CoSara-branded version of the Co-Dx PCR Pro point-of-care instrument, in select labs across India for TB testing evaluation.
CoSara expects to manufacture and distribute Co-Dx PCR platform products, including PCR test kits and the sample lysis instrument, in India under the CoSara brand.
India Represents Key Market For TB Testing
India accounts for a significant share of the global tuberculosis burden, 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, especially in decentralized settings.
In March, Co-Diagnostics shipped PCR Pro instruments, Co-Dx PCR MTB test kits for tuberculosis, and proprietary sample preparation instruments to begin clinical performance studies of the TB test on the PCR platform.
On March 9, the World Health Organization (WHO) issued recommendations for the first time on near-point-of-care (NPOC) molecular diagnostics and easy-to-collect tongue swabs for patients who cannot produce sputum samples, to expand access to TB testing.
The company already aligns its PCR testing platform and NPOC TB test kit with this new guidance.
CODX Price Action: Co-Diagnostics shares were up 1.69% at $2.40 during premarket trading on Wednesday. The stock is trading near its 52-week low of $1.26, according to Benzinga Pro data.
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This article EXCLUSIVE: Co-Diagnostics Marks New Milestone as India TB Test Clinical Studies Begin originally appeared on Benzinga.com.
