US Market News
1月前
Co-Diagnostics Joint Venture CoMira Finalizes Lease Agreement for Manufacturing Facility in Saudi Arabia's Sudair Industrial CityMay 8, 2026 9:00 AM
PR Newswire (US) Lease execution highlights transition from approval to development and advances localized manufacturing strategy in the Kingdom of Saudi Arabia in accordance with Vision 2030SALT LAKE CITY, May 8, 2026 /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 its joint venture, CoMira Diagnostics LLC ("CoMira"), has finalized a lease agreement for its planned manufacturing facility in Sudair Industrial City in the Kingdom of Saudi Arabia ("KSA"). The lease execution represents a key milestone as CoMira advances domestic manufacturing capabilities within the KSA and follows the Company's previously announced approval for an industrial land allocation in Sudair Industrial City by the Saudi Authority for Industrial Cities and Technology Zones ("MODON")."Co-Dx continues to advance our CoMira joint venture, with today's lease finalization marking an important milestone in expanding our presence in the KSA," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Executing the lease moves us from planning into the execution phase of development and reflects ongoing progress in localizing our platform within Saudi Arabia. We believe this initiative supports the Kingdom's Vision 2030 goals related to healthcare infrastructure, domestic manufacturing, and supply-chain resilience."The lease covers an industrial facility of approximately 14,400 square feet in Sudair Industrial City, one of Saudi Arabia's leading industrial hubs. The facility is designated for approved manufacturing activities, including diagnostic instruments, laboratory testing equipment, and medical consumables, and is intended to support CoMira's planned manufacturing activities related to the Co-Dx PCR platform* and other Co-Dx technology, subject to applicable regulatory approvals and operational requirements.The turnkey nature of the facility is expected to support a more efficient transition to operational readiness compared to traditional ground-up development, aligning with the Company's focus on capital-efficient expansion.Ihssan Rjoob, CEO of CoMira Diagnostics, remarked "Sudair Industrial City is intended to play a central role in Saudi Arabia's Vision 2030 initiative to diversify the economy and expand local manufacturing capabilities. We believe that establishing a presence within this industrial ecosystem aligns CoMira with national priorities around healthcare localization and industrial development."CoMira is focused on establishing localized manufacturing and distribution capabilities across Saudi Arabia and the broader Middle East and North Africa (MENA) region. The Company believes that domestic production of molecular diagnostics within the Kingdom may offer strategic advantages, particularly in government procurement processes that prioritize locally manufactured healthcare solutions.In addition, the Company believes that as relevant regulatory clearances are obtained by the U.S. FDA, the Co-Dx PCR platform may be introduced into the Saudi market through a more streamlined regulatory pathway compared to other international jurisdictions, potentially supporting earlier commercial activity as the facility is developed.This announcement represents the latest step in Co-Diagnostics' broader strategy to deploy its platform globally through localized partnerships, including its CoSara joint venture in India, and reflects the Company's continued focus on scalable, capital-efficient international expansion.*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. 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) and 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 can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding: (i) the planned development, timing, scope, and operationalization of a manufacturing facility by CoMira Diagnostics; (ii) the ability of such facility to support manufacturing of molecular diagnostic instruments and assays; (iii) expectations regarding CoMira's positioning as an early domestic manufacturer within the Kingdom of Saudi Arabia; (iv) the potential benefits of local manufacturing, including participation in government procurement programs and contribution to Saudi Arabia's Vision 2030 objectives; and (v) the Company's broader international expansion strategy across the Middle East and North Africa. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management as of the date of this release. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks associated with satisfying infrastructure requirements and other conditions precedent; risks related to the design, financing, construction, and timely completion of the contemplated manufacturing facility; risks associated with operating through a joint venture, including governance, funding, and partner-related risks; risks related to obtaining and maintaining required regulatory approvals in the Kingdom of Saudi Arabia and other jurisdictions; risks that anticipated benefits of localization and participation in government procurement programs are not realized; uncertainties associated with market acceptance and adoption of the Company's products; competitive dynamics in the global molecular diagnostics market; execution risks associated with international expansion; and general economic, geopolitical, and public health conditions in the regions in which the Company operates or intends to operate. Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-joint-venture-comira-finalizes-lease-agreement-for-manufacturing-facility-in-saudi-arabias-sudair-industrial-city-302766568.htmlSOURCE Co-Diagnostics Original: Co-Diagnostics Joint Venture CoMira Finalizes Lease Agreement for Manufacturing Facility in Saudi Arabia's Sudair Industrial City
US Market News
2月前
Co-Diagnostics Reports Full Year 2025 Financial ResultsMarch 31, 2026 4:01 PM
PR Newswire (US)
Advancing Global Commercialization Strategy Through CoSara and CoMira Joint VenturesProgressing Clinical Pipeline and Regulatory Pathways for PCR PlatformStrengthening Technology Leadership with AI Integration and Expanding IP PortfolioSALT LAKE CITY, March 31, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX) ("Co-Diagnostics," "Co-Dx," or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the full year ended December 31, 2025.
Full Year 2025 Financial Results:Revenue of $0.6 million, compared to $3.9 million in 2024, primarily due to lower grant revenueOperating expenses of $50.6 million, compared to $43.0 million in 2024, driven by a non-cash impairment charge of $18.9 million from revaluation of intangible assetsOperating loss of $50.2 million, compared to $40.1 million in 2024Net loss of $46.9 million, or $35.25 per share, compared to net loss of $37.6 million, or $37.22 per share in 2024, primarily due to intangible asset impairment charges and lower grant revenue, partially offset by decreases in operating expenses and a benefit from income taxesAdjusted EBITDA loss of $28.0 million, compared to a loss of $33.5 million in 2024Cash, cash equivalents, and marketable investment securities totaled $11.9 million as of December 31, 2025, compared to $29.7 million as of December 31, 2024Full Year 2025 Business Highlights:Closed $3.8 million offering of 9.62 million shares of common stock at an offering price of $0.40 per share on a pre-reverse split basisClosed $7.0 million offering of 12.7 million shares of common stock at an offering price of $0.55 per share on a pre-reverse split basisContinued advancement of CoSara Diagnostics joint venture in India, including regulatory progress and manufacturing readiness for PCR Pro® instrument*Signed definitive agreement with Arabian Eagle to establish CoMira Diagnostics joint venture in Saudi Arabia; currently progressing on execution and finalizing lease for manufacturing facilityInitiated and advanced clinical evaluations of upper respiratory multiplex testFurther progressed development across pipeline programs, including tuberculosis (TB) and HPV testsExpanded the AI business unit, integrating machine learning capabilities into the Co-Dx™ Primer Ai™ platformStrengthened the intellectual property portfolio with a new international patent granted in AustraliaEngaged Maxim Group to pursue SPAC transaction for CoSara DiagnosticsReceived recognition from Utah Governor's Office and BioUtah for the formation of CoMira DiagnosticsRecent Developments:Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, representing a key regulatory milestone and enabling commercialization readinessSigned an agreement to expand CoSara Diagnostics' commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the regional addressable market to approximately $13 billionInitiated shipments of PCR Pro® instruments and tuberculosis (TB) test* materials to India to support upcoming clinical performance studies, with the instrument and test kits being aligned with new WHO guidance on TB testingStrengthened the intellectual property portfolio with a new international patent granted in Japan"Over the past year, we made meaningful progress across multiple initiatives that have positioned the Company for its next phase of growth, including advancing our clinical pipeline, expanding our global footprint, and preparing for commercialization of the platform in 2026," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Importantly, we have remained focused on execution and continued to build momentum across the business. Our strategy is centered on four key pillars: advancing CoSara and our broader opportunity in India, executing on our CoMira joint venture in the Middle East and Northern Africa, progressing our clinical programs toward key regulatory milestones, and expanding our AI-driven capabilities. Together, these initiatives support our scalable, globally deployable diagnostics platform and reinforce our focus on long-term value creation."Mr. Egan continued, "Based on dramatically reduced rates of COVID prevalence in our clinical study locations, we are currently planning on an initial FDA 510(k) submission for our upper respiratory test focused on flu A, flu B, and RSV. As we move forward, we remain committed to disciplined performance as we advance toward commercialization, and we anticipate that this modified approach will allow us to accelerate regulatory and commercialization timelines while retaining the flexibility to incorporate COVID into the test at a later stage if conditions change."We believe the progress we've made in our clinical studies and on all other initiatives are creating a clear path to unlock the full potential of our platform as we enter the next phase of execution in 2026."Conference Call and Webcast:Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:Webcast: ir.co-dx.com on the Events & Webcasts page, or accessible directly hereConference Call: 1-888-880-3330 (Toll Free) or 1-646-357-8766 (Toll)The call will be recorded and later made available on the Company's website.*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.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) and to identify genetic markers for use in applications other than infectious disease.Non-GAAP Financial Measures:
This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net loss excluding depreciation, amortization, (gain) loss on disposition of assets, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, impairment charges and realized gain (loss) on investments. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company's management uses this non-GAAP measure to compare the Company's performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company's financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company's financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company's business.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. 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 in this release include statements regarding (i) advancement into clinical evaluations and continued development and regulatory submissions for the Co-Dx PCR platform and (ii) our belief that the platform will play a key role in transforming the global accessibility of diagnostic testing solutions. 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 31, 2026, 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. CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS
December 31,
2025
December 31,
2024
Assets
Current assets
Cash and cash equivalents
$11,884,607
$2,936,544
Marketable investment securities
-
26,811,098
Accounts receivable, net
190,375
132,570
Inventory, net
992,397
1,072,724
Income taxes receivable
44,559
-
Prepaid expenses and other current assets
581,527
1,338,762
Total current assets
13,693,465
32,291,698
Property and equipment, net
2,272,098
2,761,280
Operating lease right-of-use asset
1,207,453
2,114,876
Intangible assets, net
7,219,000
26,101,000
Investment in joint ventures
350,569
294,304
Total assets
$24,742,585
$63,563,158
Liabilities and stockholders' equity
Current liabilities
Accounts payable
$1,878,225
$3,294,254
Accrued expenses
865,301
2,562,169
Operating lease liability, current
662,258
915,619
Contingent consideration liabilities, current
119,036
502,819
Deferred revenue
14,800
40,857
Total current liabilities
3,539,620
7,315,718
Long-term liabilities
Income taxes payable
-
713,643
Operating lease liability
574,301
1,236,560
Contingent consideration liabilities
-
422,080
Total long-term liabilities
574,301
2,372,283
Total liabilities
4,113,921
9,688,001
Commitments and contingencies (Note 13)
Stockholders' equity
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively
-
-
Common stock, $0.001 par value; 100,000,000 shares authorized; 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 and 1,263,408 shares issued and 1,101,785 shares outstanding as of December 31, 2024
67,700
37,902
Treasury stock, at cost; 161,623 shares held as of December 31, 2025 and December 31, 2024, respectively
(15,575,795)
(15,575,795)
Additional paid-in capital
116,510,298
102,472,210
Accumulated other comprehensive income
-
418,443
Accumulated deficit
(80,373,539)
(33,477,603)
Total stockholders' equity
20,628,664
53,875,157
Total liabilities and stockholders' equity
$24,742,585
$63,563,158
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Years Ended December 31,
2025
2024
Product revenue
$418,205
$770,048
Grant revenue
204,284
3,145,112
Total revenue
622,489
3,915,160
Cost of revenue
222,377
999,124
Gross profit
400,112
2,916,036
Operating expenses
Sales and marketing
2,381,131
4,483,339
General and administrative
9,058,283
16,157,152
Research and development
19,137,242
20,979,589
Depreciation and amortization
1,106,808
1,377,266
Impairment charges
18,882,000
-
Total operating expenses
50,565,464
42,997,346
Loss from operations
(50,165,352)
(40,081,310)
Other income, net
Interest income, net
292,932
1,091,825
Realized gain on investments
683,365
870,745
Gain (loss) on disposition of assets
(82,421)
8,291
Gain on remeasurement of acquisition contingencies
805,863
714,876
Loss on equity method investment in joint ventures
(46,301)
(186,067)
Total other income, net
1,653,438
2,499,670
Loss before income taxes
(48,511,914)
(37,581,640)
Income tax provision (benefit)
(1,615,978)
57,368
Net loss
$(46,895,936)
$(37,639,008)
Other comprehensive income (loss)
Change in net unrealized gains (losses) on marketable securities, net of tax
(418,443)
271,743
Total other comprehensive income (loss)
$(418,443)
$271,743
Comprehensive loss
$(47,314,379)
$(37,367,265)
Loss per common share:
Basic and Diluted
$(35.25)
$(37.22)
Weighted average shares outstanding:
Basic and Diluted
1,330,200
1,011,179
CO-DIAGNOSTICS, INC. AND SUBSIDIARIESGAAP AND NON-GAAP MEASURES Reconciliation of net loss to adjusted EBITDA:
Years Ended December 31,
2025
2024
Net loss
$(46,895,936)
$(37,639,008)
Interest income, net
(292,932)
(1,091,825)
Realized gain on investments
(683,365)
(870,745)
Depreciation and amortization
1,106,808
1,377,266
(Gain) loss on disposition of assets
82,421
(8,291)
Change in fair value of contingent consideration
(805,863)
(714,876)
Stock-based compensation expense
2,248,053
5,434,904
Income tax provision
(1,615,978)
57,368
Impairment charges
18,882,000
-
Adjusted EBITDA
$(27,974,792)
$(33,455,207)
Reconciliation of net loss to adjusted net loss:
Net loss
$(46,895,936)
$(37,639,008)
Impairment charges
18,882,000
-
Adjusted net loss
$(28,013,936)
$(37,639,008)
View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-reports-full-year-2025-financial-results-302730537.htmlSOURCE Co-Diagnostics
Original: Co-Diagnostics Reports Full Year 2025 Financial Results
US Market News
3月前
Co-Diagnostics Signs Agreement to Significantly Expand Commercial and Distribution Territory Across South AsiaMarch 20, 2026 8:00 AM
PR Newswire (US)
Expansion into Bangladesh, Pakistan, Nepal, and Sri Lanka increases TAM in region to $13 billion and supports commercialization strategy for the PCR Pro® and SARAGENE® product lineSALT LAKE CITY, March 20, 2026 /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 Company has signed an agreement for CoSara Diagnostics Pvt. Ltd. ("CoSara"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group"), to significantly expand its commercial and distribution territory across South Asia to now include Bangladesh, Pakistan, Nepal, and Sri Lanka.
The expansion significantly increases CoSara's addressable market across South Asia, bringing the total regional opportunity to an estimated $13.0 billion based on internal analyses and third-party market data. It also supports CoSara's plans to commercialize the CoSara PCR Pro® point-of-care instrument and tests as well as the SARAGENE® product line across the region, subject to applicable regulatory approvals in each jurisdiction. As part of this expansion, CoSara is working to establish distribution channels in these newly added markets, including evaluating regulatory pathways, identifying priority customer segments, and engaging regional distribution partners.Mohal Sarabhai, CEO of CoSara, commented, "South Asia represents a large and rapidly growing market for molecular diagnostics, with significant need for easily accessible, non-invasive, quick and reliable testing solutions. Expanding our territory allows us to begin building relationships with regional partners and positions us to support the future commercialization of the point-of-care PCR platform across these markets, increasing access to molecular tests for tuberculosis, HPV, and upper respiratory infections."Co-Diagnostics CEO Dwight Egan added, "This expansion reflects our broader strategy of establishing regional infrastructure ahead of product commercialization. By building local manufacturing and distribution capabilities in key regions, including the United States, South Asia, and the Middle East and North Africa, we are positioning Co-Dx to support scalable, global deployment of our PCR point-of-care platform and drive long-term growth."To support these efforts, CoSara plans to host a virtual distributor information session in Q2 2026, followed by an in-person distributor meeting and training event later this summer. Distributors interested in participating may contact the Company at info@co-dx.com for more information.*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. 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) and 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 can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding: the expected benefits of CoSara's expansion into additional South Asian markets, including the size and potential of the addressable market; plans to establish and develop distribution channels and partnerships in newly added territories; the timing, scope, and success of commercialization efforts for the Co-Dx PCR Pro® instrument, SARAGENE® product line, and related tests; anticipated regulatory pathways, submissions, approvals, and requirements in India and other jurisdictions; the Company's ability to build regional manufacturing and distribution infrastructure; planned distributor engagement activities and their expected outcomes; and the Company's broader strategy for global deployment and adoption of its PCR platform. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management as of the date of this release. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks related to the Company's ability to obtain necessary regulatory approvals in multiple jurisdictions; uncertainties associated with market acceptance and adoption of the Company's products; the ability to successfully establish and manage distribution relationships; competitive dynamics in the global molecular diagnostics market; execution risks associated with international expansion; and general economic, geopolitical, and public health conditions in the regions in which the Company operates or intends to operate. Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 27, 2025, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-signs-agreement-to-significantly-expand-commercial-and-distribution-territory-across-south-asia-302719339.htmlSOURCE Co-Diagnostics
Original: Co-Diagnostics Signs Agreement to Significantly Expand Commercial and Distribution Territory Across South Asia
US Market News
3月前
Co-Diagnostics Receives Japanese Patent Covering Co-Dx PCR Platform TechnologiesMarch 12, 2026 9:00 AM
PR Newswire (US)
SALT LAKE CITY, March 12, 2026 /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 Japan Patent Office ("JPO") has granted Japanese Patent No. 7797537, titled "Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis." The patent further strengthens Co-Dx's intellectual property portfolio and supports the innovativeness of its novel Co-Dx PCR Pro® instrument, test cups, and other aspects of the point-of-care platform*.
Initially registered on December 26, 2025, the patent includes 34 claims and was filed under the Patent Cooperation Treaty (PCT) to allow the Company to pursue coordinated international protection in countries around the world with a single application."The Japan Patent Office is considered one of the world's most rigorous and meticulous in its review process," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "We believe that receiving such a comprehensive patent by the JPO illustrates the uniqueness and innovation of the Co-Dx platform, and its potential for transforming how and where infectious diseases are diagnosed. This patent reinforces the global protection of our platform technologies and supports our strategy to expand access to affordable, high-performance point-of-care PCR testing solutions worldwide."The issuance follows the patent granted by the Australian Patent Office in 2025 and further expands the Company's growing patent portfolio, which is designed to protect the Co-Dx PCR platform and associated technologies in key international markets. By securing intellectual property rights in Japan, Co-Diagnostics strengthens its competitive positioning and enhances its ability to pursue commercial opportunities, partnerships, and regulatory initiatives in the region.Co-Diagnostics' Co-Dx PCR point-of-care system 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 aims to enable rapid, sensitive, and specific molecular diagnostics across a broad range of applications.The 34 claims in the patent cover the fundamental systems, methods, and apparatus for automated, self-contained biological analysis performed by Co-Dx's PCR platform, and encompasses both the Co-Dx instrument and its proprietary test cups designed for use with the system.*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. 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 cleared for sale) and 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 be identified by words such as "believes," "expects," "anticipates," "intends," "plans," "may," "will," "potential," "could," and similar expressions, or the negative of these terms. These statements include, but are not limited to, statements regarding the potential applications, capabilities, regulatory status, commercialization prospects, and market opportunities for the Company's Co-Dx PCR platform, including the Co-Dx PCR Pro® instrument and related technologies, as well as the potential impact of the Company's intellectual property portfolio, including recently issued patents. Forward-looking statements are based on management's current expectations and assumptions as of the date of this press release and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to regulatory review and approvals, product development and validation, intellectual property protection, market acceptance of new diagnostic technologies, commercialization efforts, competition, and other risks described in the Company's filings with the Securities and Exchange Commission, including the Risk Factors section of the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 27, 2025, and subsequent reports filed with the SEC. Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances after the date of this press release.
View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-receives-japanese-patent-covering-co-dx-pcr-platform-technologies-302711784.htmlSOURCE Co-Diagnostics
Original: Co-Diagnostics Receives Japanese Patent Covering Co-Dx PCR Platform Technologies
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