Co-Diagnostics (NASDAQ: CODX) 2025 revenue plunges as cash declines

Rhea-AI Filing Summary

Co-Diagnostics reported sharply weaker 2025 results. Revenue fell to $0.6 million from $3.9 million in 2024, mainly from lower grant revenue, while an $18.9 million intangible impairment helped drive an operating loss of $50.2 million and a net loss of $46.9 million, or $35.25 per share.

Adjusted EBITDA loss improved to $28.0 million from $33.5 million, but cash, cash equivalents and marketable securities dropped to $11.9 million from $29.7 million, reducing financial flexibility. Management highlighted progress on its PCR platform, AI-enabled Primer Ai platform, and joint ventures CoSara in India and CoMira in Saudi Arabia, including new patents and regional expansion agreements.

Positive

• None.

Negative

• Revenue collapse and larger loss: 2025 revenue fell to $0.6 million from $3.9 million and net loss widened to $46.9 million, driven by lower grant revenue and an $18.9 million impairment.
• Cash position weakened: Cash, cash equivalents and marketable securities declined to $11.9 million at December 31, 2025 from $29.7 million a year earlier, indicating substantial cash burn and reduced balance sheet strength.

Insights

Equity analyst

Revenue collapsed and cash burned, partially offset by pipeline and JV progress.

Co-Diagnostics saw 2025 revenue drop to $0.6 million from $3.9 million, largely from lower grant revenue, while operating expenses reached $50.6 million including $18.9 million of impairment charges. This produced a net loss of $46.9 million, widening from $37.6 million in 2024.

Cash, cash equivalents and marketable securities declined to $11.9 million at December 31, 2025 from $29.7 million a year earlier, signaling significant cash burn. Adjusted EBITDA loss narrowed to $28.0 million from $33.5 million, reflecting cost actions once non-cash items are excluded.

Strategically, the company advanced its PCR platform and global footprint via the CoSara and CoMira joint ventures, obtained CDSCO approval for the PCR Pro instrument in India, and expanded South Asia distribution to a roughly $13 billion addressable market. Management is planning an initial FDA 510(k) submission for an upper respiratory test focusing on flu A, flu B and RSV, framing 2026 as a key commercialization phase.

8-K Event Classification

3 items: 2.02, 7.01, 9.01

3 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Revenue 2025: $0.6 million Net loss 2025: $46.9 million Adjusted EBITDA 2025: $28.0 million loss +5 more

8 metrics

Revenue 2025 $0.6 million Full year 2025 total revenue vs. $3.9 million in 2024

Net loss 2025 $46.9 million Full year 2025 net loss vs. $37.6 million in 2024

Adjusted EBITDA 2025 $28.0 million loss Non-GAAP adjusted EBITDA loss vs. $33.5 million loss in 2024

Impairment charges $18.9 million 2025 impairment from revaluation of intangible assets

Cash and securities $11.9 million Cash, cash equivalents and marketable securities at December 31, 2025 vs. $29.7 million in 2024

Total assets $24.7 million Total assets at December 31, 2025 vs. $63.6 million in 2024

Expanded South Asia market $13 billion Approximate diagnostics addressable market after CoSara territory expansion

Weighted average shares 1,330,200 shares 2025 basic and diluted weighted average shares outstanding

Key Terms

Adjusted EBITDA, impairment charges, non-GAAP financial measure, joint venture, +2 more

6 terms

Adjusted EBITDA financial

"This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net loss excluding depreciation, amortization..."

Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.

impairment charges financial

"driven by a non-cash impairment charge of $18.9 million from revaluation of intangible assets"

Impairment charges are one-time accounting write-downs taken when a company decides an asset — like a factory, brand, patent, or investment — is worth less than it was recorded for. Like marking down the price of a damaged item on a store shelf, they reduce reported profits and the asset’s book value; investors watch them because they can signal lasting business problems or change future earnings and balance-sheet strength.

non-GAAP financial measure financial

"the press release, which includes information regarding the Company’s use of a non-GAAP financial measure, is furnished as Exhibit 99.1"

A non-GAAP financial measure is a way companies present their financial results that excludes certain expenses or income to show how they believe their core business is performing. It matters because it can give a clearer picture of how the company is really doing, but it can also be used to make results look better than they actually are.

joint venture financial

"Continued advancement of CoSara Diagnostics joint venture in India, including regulatory progress and manufacturing readiness"

A joint venture is when two or more companies team up to work on a specific project or business idea, sharing both the risks and the rewards. It’s like friends starting a lemonade stand together—each contributes resources and they split the profits, making it easier to succeed than going alone.

510(k) submission regulatory

"we are currently planning on an initial FDA 510(k) submission for our upper respiratory test focused on flu A, flu B, and RSV"

A 510(k) submission is a regulatory packet sent to the U.S. Food and Drug Administration showing a medical device is substantially similar to an already-allowed device so it can be marketed without a full, new safety review. For investors, clearance via 510(k) cuts time and cost to bring a device to market and reduces regulatory risk—think of it as proving a new model is close enough to a trusted one to sell it more quickly.

contingent consideration financial

"Change in fair value of contingent consideration | | | (805,863)"

Contingent consideration is an additional payment agreed when one company buys another that will be paid later only if specific future targets are met, such as revenue, profit, or regulatory milestones. It matters to investors because it shifts risk between buyer and seller and affects the acquiring company's future cash flow and reported value — like promising a bonus after results are proven.

Earnings Snapshot

Revenue: $0.6 million

Full year 2025

Revenue $0.6 million

Net loss $46.9 million

Adjusted EBITDA $28.0 million loss

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 31, 2026

CO-DIAGNOSTICS, INC.

(Exact name of small business issuer as specified in its charter)

Utah		1-38148		46-2609363
(State or other jurisdiction of		(Commission		(IRS Employer
incorporation or organization)		File Number)		Identification Number)

2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109

(Address of principal executive offices)

(801) 438-1036

(Issuer’s telephone number)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		CODX		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On March 31, 2026, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its year ended December 31, 2025. The full text of the press release, which includes information regarding the Company’s use of a non-GAAP financial measure, is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore, the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

Item 7.01. Regulation FD. Disclosure.

The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.:		Description:
99.1		Press Release, dated March 31, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

	CO-DIAGNOSTICS, INC.
Date: March 31, 2026	By:	/s/ Brian Brown
	Name:	Brian Brown
	Title:	Chief Financial Officer
		(Principal Financial and Accounting Officer)

Exhibit 99.1

Co-Diagnostics Reports Full Year 2025 Financial Results

Advancing Global Commercialization Strategy Through CoSara and CoMira Joint Ventures

Progressing Clinical Pipeline and Regulatory Pathways for PCR Platform

Strengthening Technology Leadership with AI Integration and Expanding IP Portfolio

Salt Lake City, UT – March 31, 2026 – 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 revenue
	●	Operating 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 assets
	●	Operating loss of $50.2 million, compared to $40.1 million in 2024
	●	Net 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 taxes
	●	Adjusted EBITDA loss of $28.0 million, compared to a loss of $33.5 million in 2024
	●	Cash, cash equivalents, and marketable investment securities totaled $11.9 million as of December 31, 2025, compared to $29.7 million as of December 31, 2024

Full 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 basis
	●	Closed $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 basis
	●	Continued 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 facility
	●	Initiated and advanced clinical evaluations of upper respiratory multiplex test
	●	Further progressed development across pipeline programs, including tuberculosis (TB) and HPV tests
	●	Expanded the AI business unit, integrating machine learning capabilities into the Co-Dx™ Primer Ai™ platform
	●	Strengthened the intellectual property portfolio with a new international patent granted in Australia
	●	Engaged Maxim Group to pursue SPAC transaction for CoSara Diagnostics
	●	Received recognition from Utah Governor’s Office and BioUtah for the formation of CoMira Diagnostics

Recent Developments:

	●	Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, representing a key regulatory milestone and enabling commercialization readiness
	●	Signed 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 billion
	●	Initiated 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 testing
	●	Strengthened 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 here

Conference 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.

Company Contact:

Andrew Benson

Head of Investor Relations

+1 801-438-1036

investors@codiagnostics.com

Investor Contact:

Valter Pinto, Managing Director

KCSA Strategic Communications

+1 212.896.1254

CODX@KCSA.com

Media Contact:

Jennifer Webb

ColtrinMethod PR

jcoltrin@coltrinmethodpr.com

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 SUBSIDIARIES

GAAP 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	)

FAQ

How did Co-Diagnostics (CODX) perform financially in 2025?

Co-Diagnostics reported 2025 revenue of $0.6 million, down from $3.9 million in 2024, and a net loss of $46.9 million versus $37.6 million. Results reflected sharply lower grant revenue and an $18.9 million intangible asset impairment charge, partly offset by lower operating expenses.

What happened to Co-Diagnostics’ cash and investments by year-end 2025?

Cash, cash equivalents and marketable investment securities totaled $11.9 million at December 31, 2025, down from $29.7 million a year earlier. The decline shows significant cash use to fund operations, even as the company continues investing in R&D, joint ventures, and its PCR diagnostic platform.

How did Co-Diagnostics’ 2025 adjusted EBITDA compare to 2024?

Adjusted EBITDA loss improved to $28.0 million in 2025 from a $33.5 million loss in 2024. This non-GAAP measure excludes items like depreciation, stock-based compensation, impairment, and investment gains, and is used by management to assess underlying operating performance trends over time.

What major non-cash charges did Co-Diagnostics record in 2025?

Co-Diagnostics recorded $18.9 million of impairment charges in 2025 related to revaluation of intangible assets. These non-cash charges significantly increased operating expenses and contributed to the wider operating and net losses, while not directly affecting the company’s cash balance that year.

What strategic initiatives did Co-Diagnostics pursue in India and South Asia?

Through its CoSara joint venture, Co-Diagnostics obtained a CDSCO license to manufacture and sell the PCR Pro instrument in India and expanded CoSara’s commercial territory across South Asia. The expanded region, including Bangladesh, Pakistan, Nepal and Sri Lanka, represents an estimated $13 billion addressable diagnostics market.

What are Co-Diagnostics’ plans for its upper respiratory multiplex test?

Co-Diagnostics advanced clinical evaluations of an upper respiratory multiplex test and now plans an initial FDA 510(k) submission focused on flu A, flu B and RSV. Management believes this modified approach could accelerate regulatory and commercialization timelines while preserving flexibility to add COVID later if needed.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 107.0 KB

Other Documents

• EX-101 XBRL SCHEMA FILE 2.9 KB
• EX-101 XBRL LABEL FILE 33.4 KB
• EX-101 XBRL PRESENTATION FILE 21.8 KB