Co-Diagnostics Inc. (NASDAQ:CODX) on Wednesday announced that it has commenced shipments of PCR Pro instruments, Co-Dx PCR MTB test kits for tuberculosis, and proprietary sample preparation instruments to its joint venture CoSara Diagnostics Pvt. Ltd. in India.

Co-Diagnostics Begins Shipments To Support India TB Studies

These materials are necessary to begin clinical performance studies of the TB test on the PCR platform, as the company completes final steps toward initiating those studies in the near term.

Last week, Co-Diagnostics signed an agreement for CoSara Diagnostics Pvt. Ltd, to expand its commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka.

WHO Guidance Aligns With Company's TB Testing Approach

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's PCR testing platform and NPOC TB test kit are already aligned with this new guidance.

Co-Diagnostics CEO Dwight Egan remarked, "We are pleased that our foresight in designing the Co-Dx PCR testing platform and TB test for broad accessibility in point-of-care and near-point-of-care settings, and to be operated with either sputum or tongue swab samples, is consistent with the direction of the WHO's recommendation."

Mr. Egan continued, "The Co-Dx PCR MTB test has continued to generate encouraging third-party preclinical results, supporting further clinical evaluation."

Regulatory Progress In India For PCR Pro Instrument

The company recently announced that the PCR Pro instrument received a license from the CDSCO to be manufactured and sold as a medical device instrument, and expects to announce the commencement of clinical performance studies in India in the near future as we prepare for a submission to the Indian regulatory authorities for clearance.

In October, Co-Diagnostics signed a definitive agreement with Arabian Eagle to establish CoMira Diagnostics, a Saudi joint venture that will manufacture, assemble, and distribute Co-Dx technologies, including the company's next-generation PCR platform.

The partnership supports Saudi Vision 2030 by focusing on healthcare innovation, industrial diversification, and localization of technology.

CODX Stock Price Activity: Co-Diagnostics shares were up 7.93% at $2.45 during premarket trading on Wednesday, according to Benzinga Pro data.

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