Co-Diagnostics, Inc. and CoSara Diagnostics to Inaugurate New Oligo Facility

Rhea-AI Summary

Co-Diagnostics (NASDAQ: CODX) announced the inauguration of CoSara Diagnostics' new oligonucleotide synthesis facility on December 11, 2024, in Ranoli, India. The facility will manufacture Co-Primers® chemistry for PCR diagnostic tests and test cups for Co-Dx's PCR testing platform, supporting the 'Make in India' initiative.

The facility aims to enhance manufacturing efficiency and facilitate access to India's healthcare market. CoSara, a joint venture between Ambalal Sarabhai Enterprises and Co-Diagnostics, plans future expansion for manufacturing the Co-Dx PCR Pro instrument and test cups for diseases like TB and HPV. The WHO reported 10.8 million TB cases in 2023, with 1.25 million deaths, making it likely the world's leading cause of death from a single infectious agent.

Positive

• New facility enables in-house Co-Primers® manufacturing, potentially reducing production costs
• Expansion supports entry into India's large healthcare market through 'Make in India' initiative
• Plans for additional facility expansion to manufacture PCR instruments and test cups

Negative

• Co-Dx PCR platform still pending FDA and regulatory approvals
• Products not yet available for sale

Insights

Market Research Analyst

The inauguration of CoSara's oligonucleotide facility in India represents a strategic move to penetrate the world's most populous market. By aligning with India's "Make in India" initiative, Co-Diagnostics gains preferential access to a massive healthcare marketplace. The facility's focus on in-house Co-Primers® synthesis is particularly significant given India's high TB burden, with 10.8 million cases and 1.25 million deaths reported in 2023.

The vertical integration through local manufacturing should improve margins and operational efficiency while reducing dependency on external suppliers. However, the company's $27.5M market cap suggests investors remain cautious about near-term prospects, likely due to pending FDA approvals for their PCR platform and associated tests.

Medical Research Analyst

The strategic importance of this facility extends beyond mere manufacturing capabilities. With TB now surpassing COVID-19 as the leading cause of death from a single infectious agent globally, Co-Diagnostics' positioning in India's diagnostic market is well-timed. The facility's ability to produce diagnostic tests for TB and HPV addresses critical healthcare needs in the region.

The planned expansion to manufacture the Co-Dx PCR Pro instrument and test cups demonstrates a comprehensive approach to diagnostic testing. However, the regulatory hurdles, particularly FDA approval for their PCR platform, remain a important milestone before full commercialization can begin.

New oligonucleotide facility is designed to support "Make in India" initiative by synthesizing Co-Primers^® in-house. Attendees of new ribbon-cutting event expected to include representatives from NGOs and government leaders

SALT LAKE CITY, Dec. 10, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that the inauguration of CoSara Diagnostics Pvt. Ltd.'s oligonucleotide synthesis facility will take place December 11, 2024, in Ranoli, India.

In support of the "Make in India" initiative, the new facility is designed to manufacture the Company's patented Co-Primers^® chemistry, which underpins Co-Dx's and CoSara's lab-based PCR diagnostic tests and which powers the test cups for the new Co-Dx PCR at-home and point-of-care testing platform*. Qualifying under this initiative is anticipated to facilitate access to India's large and robust healthcare marketplace.

"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, the joint venture between Ambalal Sarabhai Enterprises Limited (ASE group) and Co-Diagnostics, Inc. "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."

The WHO reported that 10.8 million people fell ill from tuberculosis, or TB, in 2023, causing an estimated 1.25 million deaths. These numbers indicate that TB has likely replaced COVID-19 as the world's leading cause of death from a single infectious agent.

Co-Diagnostics' 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. (an ASE group company) 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."

Invitations to the event may be requested via info@cosara.in. 

*The Co-Dx PCR platform (including the PCR Home^™, PCR Pro^™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.

About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.

Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Forward-looking statements include statements made with respect to accessing the Indian healthcare market, to reducing overheads and to our Co-Dx PCR platform and forthcoming tests. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

Please note that we disclaim any responsibility for the content of external links provided in this press release. These links are provided solely for the reader's convenience and do not constitute an endorsement by the Company.

 

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SOURCE Co-Diagnostics

FAQ

When will CoSara Diagnostics' new oligonucleotide facility open in India?

The facility inauguration is scheduled for December 11, 2024, in Ranoli, India.

What will the new CODX facility in India manufacture?

The facility will manufacture Co-Primers® chemistry for PCR diagnostic tests and test cups for Co-Dx's PCR testing platform.

Has the FDA approved Co-Dx PCR platform (CODX)?

No, the Co-Dx PCR platform, including PCR Home™, PCR Pro™, mobile app, and associated tests, is still under FDA review and not yet available for sale.