Co-Diagnostics Announces Development of Proprietary Sample Prep Instrument for PoC Testing

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) announced development of a proprietary sample preparation instrument for its point-of-care Co-Dx PCR MTB test, designed for low-cost, user-friendly sample processing in resource-limited settings. The device supports sputum and a novel tongue swab method, uses single-button operation with no measuring tools, and includes a built-in safety feature to inactivate live organisms. Clinical evaluations in India for the MTB test are expected to begin before year-end 2025. Manufacturing is anticipated with Systronics under India’s "Make in India" initiative.

Insights

Diagnostics Product Strategist

New low-cost sample prep instrument targets decentralizing PCR for TB testing in India; key milestones: clinical evaluation and local manufacturing.

Co-Diagnostics built a simple, single-button instrument to prepare sputum and tongue swab samples for its PoC Co-Dx PCR MTB Test. The device claims operator safety via an inactivation step and aims for low production cost through a manufacturing tie-up with Systronics, enabling "Make in India" benefits.

The outcome depends on three concrete items. First, initiation and results of clinical evaluations in India before year-end will determine clinical usability. Second, qualification of Systronics as the manufacturing partner and scale-up under the "Make in India" framework will affect unit cost and supply. Third, regulatory reviews noted for the broader Co-Dx PCR platform may influence market access outside India. Watch these items over the next 3–12 months for practical validation and supply signals.

New device has the potential to help empower decentralized PCR testing in nearly 30,000 primary health centers across India, advancing efforts to improve availability of life-saving TB diagnostics

SALT LAKE CITY, Oct. 16, 2025 /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, announced today the development of a proprietary sample preparation instrument designed to streamline and simplify the workflow for its point-of-care (PoC) Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test*.

The new instrument has been engineered to deliver a low-cost, user-friendly solution for sample processing in resource-limited PoC and near-PoC settings, supporting both sputum and the novel tongue swab sample collection used in the Company's upcoming MTB test, which is expected to begin clinical evaluations in India before year-end. The single-button operation and no need for measurement or dispensing tools enable rapid sample prep with minimal training, while incorporating a built-in safety feature to inactivate live organisms in the sample and help protect test operators.

"While tuberculosis ranks as the deadliest infectious disease in the world, it is treatable and curable if diagnosed. Decentralizing PCR out of the roughly 1,000 district hospitals and making the technology available to the nearly 30,000 primary health centers currently performing microscopy is among the most significant transitions for the tuberculosis testing landscape in India," explained Dwight Egan, CEO of Co-Diagnostics. "As we have previously discussed, a limiting factor for real-time PCR TB diagnostics at the point-of-care has been preparing the patient's sample for the PCR process, making the genetic material of the TB bacterium accessible to PCR primers, while ensuring workflow simplicity and operator safety. Sample extraction performed in centralized labs for higher-throughput PCR tests has historically also been costly and time-consuming."

Mr. Egan continued, "The new instrument will allow us to meet our high standards for performance, cost-efficiency, safety, and ease-of-use, all while keeping production costs low and strengthening our ties with our existing manufacturing partnerships in India. We believe that the new device is also a step towards affordable preparation of other sample types at the point-of-care, creating opportunities to expand into blood-borne pathogens and representing a major step forward in our mission to make PCR testing more accessible worldwide, especially in challenging environments with the most pressing need for affordable life-saving diagnostics."

Systronics, a subsidiary of Ambalal Sarabhai Enterprises Limited (ASE Group) and sister company of Synbiotics Ltd (the Company's partner in its Indian JV CoSara Diagnostics Pvt. Ltd.), is anticipated to be the Company's manufacturing partner for the instrument, allowing the device to qualify for the advantages of goods manufactured under the "Make in India" initiative. 

*The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.

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 to detect and/or analyze 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 (subject to regulatory review and not currently for sale) to identify genetic markers for use in applications other than infectious disease.

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to, statements regarding planned manufacturing arrangements and the sample preparation instrument's ability to meet Co-Diagnostics' high standards for performance, cost-efficiency, safety and ease-of-use, while strengthening ties with existing Indian partnerships. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these statements, including but not limited to risks related to successfully completing the development of an instrument that has the potential to help empower decentralized PCR testing in nearly 30,000 primary health centers across India, that it is a step towards affordable preparation of other sample types at the point-of-care, creating opportunities to expand into blood-borne pathogens, that it can be manufactured at scale to meet customer demands while qualifying under the "Make in India" initiative, and other risks described in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. All forward-looking statements are based on current expectations and assumptions, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

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SOURCE Co-Diagnostics

FAQ

What did Co-Diagnostics (CODX) announce about a new sample prep instrument on October 16, 2025?

Co-Diagnostics announced development of a low-cost, single-button sample preparation instrument for its PoC Co-Dx PCR MTB test, supporting sputum and tongue swab samples.

When will Co-Diagnostics (CODX) begin clinical evaluations of the MTB test in India?

Clinical evaluations of the Co-Dx PCR MTB test in India are expected to begin before year-end 2025.

How does the new Co-Diagnostics (CODX) instrument improve point-of-care TB testing workflow?

The instrument simplifies workflow with single-button operation, no measuring/dispensing tools, rapid prep with minimal training, and a built-in organism inactivation safety feature.

Will Co-Diagnostics (CODX) manufacture the new instrument in India?

Co-Diagnostics anticipates Systronics to be the manufacturing partner, allowing qualification under the "Make in India" initiative.

Which sample types will Co-Diagnostics (CODX) support with the new preparation device?

The device is engineered to support both traditional sputum samples and a novel tongue swab sample collection for the MTB test.

What potential impact did Co-Diagnostics (CODX) cite for decentralizing PCR TB testing in India?

The company highlighted decentralizing PCR from ~1,000 district hospitals to nearly 30,000 primary health centers currently performing microscopy as a major transition for TB testing access.