Co-Diagnostics Receives Grant of Australian Patent Covering Co-Dx PCR Platform Technologies

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) announced that the Australian Patent Office granted Australian Patent No. AU2022270084A1, strengthening IP around its Co-Dx PCR platform.

The patent, filed in May 2022 and granted in June 2025, covers the design and operation of the Co-Dx PCR Pro instrument and test cups and protects the company’s Co-Primers® approach for nucleic acid detection. The grant provides regional protection in Australia as the company advances a Co-Dx PCR Flu A/B, COVID, RSV multiplex test currently in clinical performance testing. The platform remains under FDA/other regulatory review and is not yet for sale.

Positive

• Australian patent AU2022270084A1 granted in June 2025
• Patent covers Co-Dx PCR Pro instrument and test cups
• Protects Co-Primers technology for nucleic acid detection
• Patent strengthens commercial defenses in Australia

Negative

• Patent protection limited to Australia (regional scope)
• Co-Dx PCR platform is under regulatory review and not for sale
• Key multiplex test is in clinical performance testing, not commercial

Key Figures

Patent number AU2022270084A1 Australian patent covering Co-Dx PCR platform technologies

Initial filing date May 2022 Australian patent application filing date for Co-Dx PCR platform

Market Reality Check

$6.12 Last Close

Volume Volume 1,227,167 vs 20-day average 1,558,055 (0.79x typical activity ahead of this news). normal

Technical Shares at $0.235 trade below the $0.34 200-day MA and only 6.33% above the 52-week low.

Peers on Argus 1 Up 1 Down

Peer moves appear mixed: scanner shows NXL up 7.94% while ALUR is down 5.22%. Broader medical-device peers in the affinity list also show both gains and losses, suggesting this CODX move is more company-specific than sector-driven.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 18	TB workshop invite	Positive	+5.3%	CoSara invited to advanced TB diagnostics course in Chennai, India.
Dec 17	Flu assay analysis	Positive	+6.5%	In silico analysis supports maintained reactivity of Logix Smart ABC test.
Dec 09	POC AI presentation	Positive	+4.5%	Presentation on portable Co-Dx PCR platform and AI integration at conference.
Dec 08	TB/HPV preclinical data	Positive	-7.4%	CoSara participation at VIROCON and Phase I/II MTB and HPV data update.
Nov 20	TB test address	Positive	-5.8%	Address on MTB test adoption and POC plans plus possible CoSara SPAC deal.

Pattern Detected

Recent platform- and TB-related announcements often saw positive reactions, but some clinically focused updates triggered negative moves, indicating inconsistent response to similar news.

Recent Company History

Over the past months, Co-Diagnostics highlighted its Co-Dx PCR platform across multiple settings. On Nov 20, 2025, it discussed MTB adoption and a potential SPAC-related transaction for CoSara, followed by TB and HPV preclinical data on Dec 8. Subsequent AI and point-of-care presentations on Dec 9 and influenza Co-Primers® analysis on Dec 17 produced gains, as did CoSara’s TB course participation on Dec 18. Today’s Australian patent further extends that IP-focused platform narrative.

Market Pulse Summary

This announcement highlights a newly granted Australian patent for the Co-Dx PCR platform, the first patent for this point-of-care system and its associated instruments and test cups. It builds on months of platform-focused communications, including TB, HPV and influenza initiatives and AI-enabled point-of-care diagnostics. Investors may watch for future regulatory clearances, additional IP grants in other regions, and progress converting this patent protection into commercial deployments once the platform clears required reviews.

Key Terms

polymerase chain reaction medical

"its approach to performing high-quality polymerase chain reaction (PCR) testing outside"

A polymerase chain reaction (PCR) is a laboratory method that makes many copies of a tiny piece of genetic material, like using a photocopier to turn one page into thousands so it can be read and analyzed. Investors care because PCR underlies many diagnostic tests, research tools and quality control processes; changes in demand, costs, accuracy or regulation of PCR can affect revenue, competitive positions and the speed at which medical products reach the market.

pcr medical

"Co-Dx PCR Pro™ instrument and test cups, including its approach to performing high-quality polymerase chain reaction (PCR) testing"

PCR (polymerase chain reaction) is a laboratory method that makes many copies of a tiny piece of genetic material (DNA or RNA) so scientists can detect and study it reliably — think of photocopying a faint, tiny note until the words are easy to read. For investors, PCR matters because it underpins diagnostic tests, drug development, and biotech tools whose sales, regulatory approvals, and real-world use can materially affect company revenues and market perceptions during health events or product launches.

nucleic acid medical

"used for nucleic acid detection and analysis. The claims specifically cover the design"

Large biological molecules—DNA and RNA—that store and carry the genetic instructions for living things, like an instruction manual that tells cells what to build and how to behave. Investors pay attention because many diagnostics, therapies and vaccines are based on reading or manipulating these molecules; successes or setbacks in those products, manufacturing, patents or regulatory approval can materially affect a company’s prospects and valuation.

point-of-care testing medical

"first patent granted for the Company's new point-of-care testing platform"

Medical tests performed at or near the site of patient care that produce rapid results without sending samples to a distant laboratory — like using a point-of-care glucose meter instead of waiting for lab work. Investors care because these tests speed treatment decisions, can lower care costs and expand the number of tests performed, creating demand for devices, supplies and software; sales hinge on accuracy, insurance coverage and regulatory approval.

multiplex test medical

"including the Co-Dx PCR Flu A/B, COVID, RSV multiplex test (currently in clinical performance testing)"

A multiplex test is a laboratory diagnostic that checks one patient sample for several different targets at the same time — for example multiple viruses, bacteria, or biological markers — like a Swiss Army knife that does several jobs at once. For investors, multiplex tests matter because they can lower costs, speed up diagnosis, increase lab throughput, and open larger sales or reimbursement opportunities, while also bringing regulatory and manufacturing complexity that can affect commercial success.

clinical performance testing medical

"RSV multiplex test (currently in clinical performance testing). Co-Diagnostics' Co-Dx PCR platform"

Clinical performance testing measures how a medical product, device, or diagnostic performs when used on real patients or in routine clinical settings, checking whether it works as intended and is safe and reliable. For investors, these results matter because they influence regulatory approval, market adoption, and the timeline and cost to bring a product to customers—similar to a road test that shows whether a new car is ready for everyday driving.

co-primers medical

"The platform leverages the Company's patented Co-Primers® technology and is intended"

Co-primers are two short DNA pieces used together to start and control copying of a specific genetic target in laboratory tests; one binds next to the other so the copying enzyme begins at the correct spot. For investors, co-primers matter because they can make diagnostic tests more accurate and faster—like using a keyed pair instead of a single key to reduce false alarms—affecting a test’s clinical reliability, regulatory approval, and market competitiveness.

fda regulatory

"subject to review by the FDA and/or other regulatory bodies and is not available for sale"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

The Australian patent represents the first patent granted for the Company's new point-of-care testing platform

SALT LAKE CITY, Dec. 29, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that the Australian Patent Office has granted Australian Patent No. AU2022270084A1, strengthening Co-Dx's intellectual property portfolio surrounding its novel Co-Dx PCR platform*.

Initially filed in May 2022 before being granted in June of this year, the patent is the first granted for the new platform and provides broad protection in Australia for the Company's proprietary system and methods used for nucleic acid detection and analysis. The claims specifically cover the design and operation of the Co-Dx PCR Pro™ instrument and test cups, including its approach to performing high-quality polymerase chain reaction (PCR) testing outside of traditional laboratory environments.

"This patent represents another significant milestone in securing global protection for our technology as we continue expanding the potential applications of the point-of-care PCR platform," said Dwight Egan, CEO of Co-Dx. "From the beginning, Co-Dx's goal has been to make accurate, accessible PCR testing available where it is needed most, and strengthening our global IP portfolio is essential to that mission."

The patent grant in Australia also provides strategic protection in a region where Co-Dx and potential commercial partners may choose to introduce or distribute the Co-Dx PCR platform in the future. Australia recently experienced a record-breaking flu season, and securing patent coverage in the market serves as a key defensive measure to protect the commercial potential of the platform, including the Co-Dx PCR Flu A/B, COVID, RSV multiplex test (currently in clinical performance testing).

Co-Diagnostics' Co-Dx PCR platform is designed to deliver gold-standard PCR accuracy in a compact, user-friendly device suitable for decentralized testing environments. The platform leverages the Company's patented Co-Primers® technology and is intended to enable rapid, sensitive, and specific molecular diagnostics across a broad range of infectious disease applications.

*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 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 (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. 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, but are not limited to, statements regarding the anticipated benefits of the Australian patent grant, the potential applications, performance, commercialization, and market opportunities of the Co-Dx PCR platform and related tests, the progress and outcomes of clinical performance testing, the prospects for regulatory review or approval by the FDA or other regulatory authorities, and the Company's ability to introduce or distribute its products in Australia or other markets, whether independently or with commercial partners. 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 27, 2025, 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.

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SOURCE Co-Diagnostics

FAQ

What did Co-Diagnostics (CODX) announce on December 29, 2025?

Co-Diagnostics announced the grant of Australian Patent AU2022270084A1 covering its Co-Dx PCR platform.

When was the Australian patent for CODX filed and granted?

The patent was filed in May 2022 and granted in June 2025.

What parts of the Co-Dx PCR system does the Australian patent cover?

The claims cover the Co-Dx PCR Pro instrument, test cups, and the company’s nucleic acid detection methods including Co-Primers.

Does the Australian patent mean CODX can sell the Co-Dx PCR platform in Australia now?

No; the platform is subject to FDA and other regulatory review and is not available for sale.

How does the patent affect CODX’s multiplex Flu A/B, COVID, RSV test?

The patent provides defensive IP protection in Australia while the multiplex test undergoes clinical performance testing.

What investor risks remain after CODX’s Australian patent grant?

Risks include regional IP limits, ongoing regulatory clearance needs, and that key tests remain in clinical testing.