Co-Diagnostics (NASDAQ:CODX) reported second-quarter 2026 revenue of $166,000, little changed from $163,000 a year earlier, as the molecular diagnostics developer continued to invest in regulatory submissions, clinical programs and international commercialization efforts.
The company posted a net loss of $6.3 million, or $1.46 per basic and diluted share, compared with a net loss of $7.7 million, or $7.00 per share, in the prior-year period. Chief Financial Officer Brian Brown said the narrower loss primarily reflected lower operating expenses, partly offset by lower other income.
FDA Submission Marks Respiratory Program Milestone
Chief Executive Officer Dwight Egan said the company completed the analytical and clinical performance studies supporting its regulatory submission for the upper respiratory multiplex assay. Co-Diagnostics subsequently submitted a Dual 510(k) and CLIA Waiver by Application to the FDA for the Flu A/B & RSV assay on the Co-Dx PCR platform.
The analytical validation program included 27 individual studies and more than 10,000 upper respiratory PCR test runs on the PCR Pro instrument, including multicenter reproducibility studies across operators, sites and instruments, Egan said. The clinical study enrolled more than 1,400 symptomatic patients at nine geographically diverse U.S. clinical sites.
Egan called the FDA submission “a major milestone” resulting from years of development, validation and regulatory preparation. He said influenza and RSV testing panels are major drivers of the seasonal respiratory testing market and have an established reimbursement code, which the company expects to support its strategy for near-patient and point-of-care settings.
Co-Diagnostics also appointed Dr. Wes Lindsey as chief scientific officer. Egan said Lindsey has more than 20 years of molecular diagnostics experience, including work on FDA submissions and commercial launches, and was recruited to strengthen the company’s scientific organization as it pursues multiple regulatory pathways and expands its product portfolio.
Tuberculosis Program Advances in India
The company said clinical studies are advancing in India for its CoSara PCR Pro instrument and CoSara PCR MTB tuberculosis test. Egan said Co-Diagnostics is targeting additional regulatory milestones later in 2026, including planned submissions to India’s Central Drugs Standard Control Organization and, subject to eligibility requirements and timing, the World Health Organization’s Expert Review Panel for Diagnostics, or ERPD.
During the question-and-answer session, Egan confirmed that the company expects to submit the tuberculosis test for ERPD assessment later this year.
The company said its CoSara joint venture in India has established manufacturing, regulatory and commercial capabilities over nearly a decade. Egan described India as one of the largest single-country tuberculosis markets. He also said that a favorable ERPD assessment could facilitate procurement in high-burden countries because the assessment can indicate eligibility for the Global Fund’s list of eligible in vitro diagnostics.
Certain costs associated with analytical and clinical validation studies needed for an ERPD assessment are largely supported by the company’s non-governmental organization partner relationships, according to Egan.
Ebola Development and Digital Infrastructure
Beyond respiratory and tuberculosis testing, Co-Diagnostics said it advanced work on an Ebola assay after the World Health Organization declared a public health emergency for Ebola. The company completed a proof-of-concept study for an assay detecting Ebola directly from plasma samples on the Co-Dx PCR Pro instrument.
Egan said it is the first blood-based assay designed for the Co-Dx PCR Pro, demonstrating potential applications beyond swab-based infectious disease testing. CoSara also continued development of Bundibugyo virus and pan-Ebola tests for centralized laboratories, and received a request through its relationship with the India Centre for Cellular and Molecular Platforms, or CCAMP, for 200 Bundibugyo tests to be evaluated by a third-party laboratory.
Asked about the Ebola development timeline, Egan said the company’s strategy is to be prepared if the test is needed. He did not provide a timeline for further development or commercialization.
The company also said it is building a connected ecosystem combining molecular diagnostics, mobile applications and cloud-based infrastructure. Egan said the platform is intended to support secure reporting, remote system management and real-time access to diagnostic data. Co-Diagnostics expects to expand the cloud infrastructure to regulatory regions where its instruments operate, including India and Saudi Arabia.
Expenses Decline as Cash Balance Falls
Second-quarter cost of revenue totaled $45,000, resulting in gross profit of about $121,000, compared with $131,000 a year earlier. Brown said current revenue remains limited and cost variability can affect gross-margin performance at this stage.
- Operating expenses declined to $6.3 million from $8.2 million a year earlier.
- Research and development expense fell to $4.2 million from $4.7 million, reflecting lower personnel and stock-based compensation costs following a completed headcount reduction.
- Sales and marketing expense decreased to $467,000 from $610,000.
- General and administrative expense declined to $1.5 million from $2.6 million, driven primarily by lower stock-based compensation and legal costs.
- Adjusted EBITDA loss narrowed to $5.8 million from $7.2 million in the prior-year quarter.
Co-Diagnostics ended June with $3.6 million in cash and cash equivalents, down from $11.9 million at the end of 2025. Total assets were $16.6 million, compared with $24.7 million at year-end, while total liabilities were $3.9 million, compared with $4.1 million.
Brown said the company expects continued operating losses in the near term as it advances clinical programs and regulatory submissions. He said Co-Diagnostics will continue evaluating potential capital sources, including equity or debt financings, strategic transactions and partnerships, while also pursuing non-dilutive funding such as grants where appropriate.
About Co-Diagnostics (NASDAQ:CODX)
Co-Diagnostics, Inc is a molecular diagnostics company headquartered in Salt Lake City, Utah, known for its proprietary CoPrimer™ technology. Founded in 2016, the company focuses on the design, development and distribution of molecular diagnostic test kits for the detection of infectious diseases, genetic mutations and other health-relevant biomarkers. Its core platform leverages patented cooperative primers, which are engineered to enhance specificity, sensitivity and cost-effectiveness compared to conventional PCR-based assays.
Through its in-house manufacturing and global supply chain partnerships, Co-Diagnostics produces a range of real-time polymerase chain reaction (qPCR) kits, reagents and customized assay development services.
