More than 1,400 patients enrolled across 9 clinical sites; analytical performance testing included 27 individual studies and over 10,000 PCR test cup runs
Analytical data to support concurrent 510(k) submission with CLIA Waiver by Application for point-of-care settings, with submission targeted for Q3 2026
SALT LAKE CITY, July 1, 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 the completion of clinical and analytical performance studies for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument* that the Company currently expects to include in its planned submission package. Completion of these studies represents a significant milestone in preparation of a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food and Drug Administration ("FDA"), targeted for Q3 2026.
"Completing both the analytical and clinical performance studies for the upper respiratory test is a significant execution milestone for Co-Diagnostics," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "The FDA 510(k) and CLIA Waiver by Application processes require substantial analytical and clinical evidence, and the depth of the work our team has completed, including 27 individual analytical studies, over 10,000 PCR test cup runs, and a clinical study enrolling more than 1,400 symptomatic patients across 9 geographically distinct US clinical sites, reflects the quality of the submission we are preparing to make. We are targeting submission in Q3 2026 and remain confident in our path to clearance."
Prior to IVD test submission to the FDA for review, medical device manufacturers are required to complete extensive analytical and clinical validation studies to demonstrate that the test performs reliably under both controlled laboratory conditions and its intended real-world use. Analytical validation of the Co-Dx PCR test included over 10,000 PCR test cup runs across 27 individual studies, including studies supporting the CLIA Waiver by Application to allow the test to be used in waived point-of-care settings. This also included a rigorous external multicenter reproducibility study demonstrating consistent performance when operated by untrained operators across multiple sites and instruments.
Mr. Egan continued, "The reproducibility study was designed to evaluate whether performance observed in clinical settings could be replicated across different operators, sites and instruments, and the results support inclusion of those data in our planned FDA submission. That consistency is central to what a CLIA Waiver requires and to our broader vision of bringing accurate, near-patient PCR diagnostics to decentralized settings. This platform was designed to perform at that standard."
*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) an expected submission to the FDA for 510(k) clearance of the test and platform; (ii) an expected CLIA Waiver submission to the FDA; (iii) the Company's ability to obtain 510(k) clearance and CLIA Waiver for the Co-Dx PCR ABR test on the PCR Pro instrument; (iv) the Company's ability to successfully commercialize the Co-Dx PCR platform upon receiving applicable regulatory clearances; and (v) the performance, reliability, and market acceptance of the Co-Dx PCR platform in point-of-care and near-patient settings. Such statements are subject to a number of risks and uncertainties, including, without limitation: FDA may not accept or clear the 510(k), may not grant the CLIA Waiver by Application, may request additional clinical or analytical data, may require labeling or intended-use changes, risks that market demand or public health conditions may change; risks related to the Company's ability to successfully complete a submission to the FDA; risks related to the Company's ability to commercialize the platform in a strategically important market, including risks that distribution partners may not successfully market, promote, or sell the Company's products; risks associated with international operations, including changing regulatory requirements, economic conditions, reimbursement environments, import/export restrictions, and foreign currency fluctuations; risks related to regulatory review by the FDA or other regulatory authorities that would be required to achieve a successful commercial launch; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technology; risks associated with dependence on third parties, suppliers, collaborators, and distribution partners; risks related to competition, technological change, and intellectual property protection; and other risks described from time to time in the Company's filings with the Securities and Exchange Commission ("SEC"). 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.
SOURCE Co-Diagnostics
