Co-Diagnostics' Joint Venture CoSara Diagnostics Announces Publication of Peer-Reviewed HPV Screening Study Using CoSara's SARAGENE® Test

Follow-up biopsies found high-grade lesions or cervical cancer in 12 of 20 HPV-positive women, in a cohort with predominantly negative cytology.

Rhea-AI Summary

Co-Diagnostics (CODX) announced publication of a peer-reviewed HPV screening study using the SARAGENE test manufactured by its Indian joint venture, CoSara Diagnostics.

Investigators screened 625 women aged 30 to 60 in Central Gujarat, India; 20 tested positive for high-risk HPV. Among those women, 18 had negative cytology results and two had low-grade abnormalities. Follow-up biopsies identified high-grade cervical lesions in nine women and invasive cervical cancer in three. Published in Infectious Agents and Cancer, the findings are preliminary because of the study design and limited HPV-positive sample; larger studies are needed for confirmation.

SARAGENE is authorized for testing in India and unavailable for sale in the United States. Co-Diagnostics is developing a separate HPV test for its Co-Dx PCR Pro platform; neither that platform nor its HPV test was evaluated in this study.

Positive

• Minor pointPublished peer-reviewed research evaluated CoSara's SARAGENE HPV-HR test in 625 women.
• Minor pointFollow-up biopsies identified high-grade lesions in nine women and invasive cancer in three among 20 HPV-positive participants.
• Minor pointSARAGENE HPV-HR is authorized for testing in India.
• Minor pointCoSara's commercial and distribution territory expanded to Bangladesh, Pakistan, Nepal and Sri Lanka beyond India.
• Minor point. Forward-looking: it has not happened yet and may not happen.Co-Diagnostics is developing a separate HPV test for its Co-Dx PCR Pro platform.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Study findings are preliminary, limited by study design and few HPV-positive participants; larger studies are needed.
• Minor pointSARAGENE HPV-HR is not available for sale in the United States.
• Minor point. Forward-looking: it has not happened yet and may not happen.SARAGENE commercialization in the expanded territory remains subject to applicable regulatory approvals.

Key Figures

Women screened: 625 women High-risk HPV-positive: 20 women Negative cytology among HPV-positive women: 18 of 20 women +1 more

Women screened

625 women

SARAGENE HPV-HR study in Central Gujarat

High-risk HPV-positive

20 women

Among the 625 women screened

Negative cytology among HPV-positive women

18 of 20 women

Study cohort

High-grade lesions or cervical cancer on follow-up biopsy

12 of 20 women

Among the HPV-positive women

Key Terms

colposcopy, low-grade squamous intraepithelial lesions, multiplex real-time PCR assay, invasive cervical carcinoma

4 terms

colposcopy medical

"Subsequent colposcopy and directed biopsy identified high-grade cervical lesions"

A colposcopy is a medical diagnostic procedure that uses a magnifying lighted instrument (a colposcope) to closely examine the cervix, vagina and vulva for abnormal tissue. During the exam the clinician may apply acetic acid or iodine to highlight suspicious areas and can take small tissue samples (biopsies) for laboratory testing; the procedure inspects and samples visible lesions but is not itself a definitive treatment and can miss lesions that lie out of view (for example, inside the cervical canal).

low-grade squamous intraepithelial lesions medical

"two had low-grade squamous intraepithelial lesions (LSIL)"

A cytology or pathology diagnosis of mildly abnormal squamous cells on the surface of an epithelial lining, most commonly the cervix, typically found on a Pap smear and abbreviated LSIL. It indicates cellular changes usually caused by human papillomavirus (HPV) infection and corresponds roughly to cervical intraepithelial neoplasia grade 1 (CIN1); the changes reflect increased cell growth but not invasive cancer. LSIL is distinguished from higher-grade lesions by its lower likelihood of immediate progression to cancer and is usually managed with surveillance or targeted diagnostic follow-up rather than urgent treatment.

multiplex real-time PCR assay technical

"a wet-reagent, laboratory-based multiplex real-time PCR assay"

A multiplex real-time PCR assay is a laboratory test that amplifies and detects the genetic material of one or more pathogens or targets in a single reaction by combining polymerase chain reaction (PCR) with fluorescent signal monitoring as amplification happens. Multiplexing means several different target sequences are tested at once using distinct probe-fluorophore pairs so the instrument can quantify each target in real time; this allows faster, sample-sparing detection but requires careful assay design and controls to avoid cross-reactivity and signal interference and is subject to regulatory validation for clinical use.

invasive cervical carcinoma medical

"invasive cervical carcinoma in three"

A cancer that begins in the cells of the cervix and has grown beyond the cervical epithelium into the underlying connective tissue or deeper structures; unlike cervical carcinoma in situ, an invasive cervical carcinoma has the ability to infiltrate nearby tissues and, potentially, spread (metastasize) to lymph nodes or distant organs. Common histologic types are squamous cell carcinoma and adenocarcinoma, and diagnosis is established by tissue biopsy showing malignant cells breaching the epithelial basement membrane.

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Follow-Up Biopsies Identified High-Grade Lesions or Cervical Cancer in 12 of 20 HPV-Positive Women, Including a Cohort with Predominantly Negative Cytology Results

CoSara to Exhibit at MICROCON 2026, the Annual Congress of the Indian Association of Medical Microbiologists

Co-Dx to Host HPV Screening Webinar on November 17 to Support Awareness Across South Asian Markets

SALT LAKE CITY, Oct. 29, 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 publication of a peer-reviewed study using the SARAGENE® Human Papillomavirus High Risk (HPV-HR) Test manufactured by CoSara Diagnostics Pvt. Ltd. ("CoSara"), the Company's joint venture in India. The study, conducted by investigators at a local institution in Gujarat, India and published in Infectious Agents and Cancer, highlights the potential role of molecular HPV testing in identifying women who warrant further evaluation, even when cytology results are negative.

Investigators used the SARAGENE® HPV-HR Test to screen samples from 625 women aged 30 to 60, collected through hospital and community screening settings in Central Gujarat, India. Twenty women tested positive for high-risk HPV; 18 had cytology results reported as negative for intraepithelial lesion or malignancy (NILM), while two had low-grade squamous intraepithelial lesions (LSIL). Subsequent colposcopy and directed biopsy identified high-grade cervical lesions (CIN II/III) in nine women and invasive cervical carcinoma in three.

The full article, "Cross-sectional assessment of high-risk HPV prevalence, genotype distribution, and associated socio-behavioural correlates among women in Central Gujarat, India," is available at https://doi.org/10.1186/s13027-026-00796-x.

"Expanding access to molecular HPV testing is an important part of strengthening cervical cancer screening, particularly in regions where access to diagnostics remains limited," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "We are excited to see CoSara's SARAGENE® test used in published research that brings the importance of molecular screening into such clear focus. Our goal through CoSara is to make high-quality, affordable molecular diagnostics more accessible to laboratories and clinicians across India and South Asia."

The SARAGENE® HPV-HR Test is a wet-reagent, laboratory-based multiplex real-time PCR assay that detects HPV-16, HPV-18 and a pooled group of 12 additional high-risk HPV genotypes. The test is authorized for testing in India and is not available for sale in the United States. The investigators noted that the findings are preliminary, given the study's design and the limited number of HPV-positive participants, and that larger studies are needed to confirm these findings.

The report comes as international efforts increasingly focus on expanding access to HPV-based cervical cancer screening. In July 2026, the World Health Organization issued guidance to help countries implement and scale HPV DNA-based screening programs. CoSara's manufacturing presence in India and regional distribution footprint provide a foundation for the Company's efforts to support broader access to molecular diagnostics.

Earlier this year, Co-Dx announced the expansion of CoSara's commercial and distribution territory beyond India to include Bangladesh, Pakistan, Nepal and Sri Lanka, supporting commercialization of the SARAGENE® product line subject to applicable regulatory approvals. In January 2026, the Company reported that CoSara's network included more than 40 distributors across India.

CoSara will exhibit at MICROCON 2026, the 49th Annual Congress of the Indian Association of Medical Microbiologists, taking place October 28 to November 1, 2026, at the All India Institute of Medical Sciences (AIIMS) Nagpur in Maharashtra, India. The five-day congress is expected to bring together hundreds of microbiologists and clinical researchers from across India, along with pathology laboratory leaders and diagnostics industry representatives. CoSara's booth will feature its molecular diagnostics portfolio, including the SARAGENE® product line.

Co-Diagnostics is also developing a separate HPV test for the Co-Dx PCR Pro® platform*, extending its development efforts into near-patient molecular testing. The SARAGENE® wet-reagent assay used in this study is distinct from that development program; the study did not evaluate PCR Pro or its HPV test.

In recognition of World Cervical Cancer Elimination Day, Co-Dx plans to host a webinar on HPV and cervical cancer screening on November 17, 2026, intended for healthcare providers, laboratory professionals and other stakeholders across South Asian markets. Interested parties may pre-register by emailing info@co-dx.com.

*The Co-Dx PCR platform (including the PCR Home^®, PCR Pro^®, mobile app, and all associated tests) has not been cleared or authorized by the FDA, 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 potential implications of the published study for molecular HPV screening; the Company's or its joint venture's ability to support broader access to molecular diagnostics through its manufacturing and distribution capabilities and to commercialize the SARAGENE® product line across India and additional South Asian markets, subject to applicable regulatory approvals; the Company's ability to successfully develop, validate and obtain regulatory authorization for a separate HPV test for the Co-Dx PCR Pro platform; the Company's ability to develop the Co-Dx PCR platform to support decentralized testing; the Company's expectations regarding future commercialization of the Co-Dx PCR platform; and the Company's and CoSara's planned participation in MICROCON 2026 and the Company's planned HPV webinar. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks that market demand or public health conditions may change; risks that the study's findings, based on a limited number of HPV-positive participants,  may not be confirmed in larger studies or support broader conclusions about diagnostic performance or screening outcomes; risks related to the Company's ability to successfully develop and validate an HPV test for the Co-Dx PCR Pro platform, including risks that regulatory authorities may require additional data, delay review or decline to grant authorization; risks related to the Company's ability to successfully develop and validate the Co-Dx PCR platform for decentralized testing applications; risks related to the Company's or its joint venture's ability to commercialize the SARAGENE® product line and the Co-Dx PCR platform in strategically important markets, including risks that distribution partners may not successfully market, promote, or sell the Company's or its joint venture's products; risks that publication of the study may not result in increased product adoption or any commercial or regulatory benefit to the Company; risks related to the Company's or its joint venture's ability to maintain and expand manufacturing and distribution capabilities to support market demand; 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 regulatory authorities that would be required to achieve a successful commercial launch; risks related to the performance, reliability, and market acceptance of the SARAGENE® product line, the Co-Dx PCR platform and other Co-Dx technologies; 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.                                         

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SOURCE Co-Diagnostics

FAQ

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What did the CoSara SARAGENE HPV screening study find?

Of 625 women aged 30 to 60 screened in Central Gujarat, India, 20 tested positive for high-risk HPV. Follow-up biopsies identified high-grade cervical lesions in nine women and invasive cervical cancer in three. Among the HPV-positive women, 18 had negative cytology results and two had low-grade abnormalities.

How conclusive are the findings from CoSara's SARAGENE HPV study?

The findings are preliminary because of the study design and limited number of HPV-positive participants, and larger studies are needed to confirm them. The research evaluated the SARAGENE laboratory test, not the separate Co-Dx PCR Pro platform or its HPV test.