The company aims to support FDA 510(k) clearance submission for its point-of-care platform detecting flu A/B, COVID-19, and RSV.
Co-Diagnostics has initiated clinical evaluations for its Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit, marking a step toward US Food and Drug Administration (FDA) regulatory submission for the company’s point-of-care molecular diagnostics platform.
The Salt Lake City-based molecular diagnostics company announced that the clinical performance testing is expected to support a 510(k) clearance submission to the FDA for both the upper respiratory multiplex point-of-care test and the Co-Dx PCR Pro instrument.
“We are pleased with the diligent work of our development team in preparing this test to begin this clinical performance testing,” says Dwight Egan, chief executive officer of Co-Diagnostics, in a release. “Regulatory clearance and commercialization of the Co-Dx PCR platform remain the company’s primary objectives, and our research suggests that the market is primed for decentralized, gold-standard PCR testing, especially for respiratory infections.”
The Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit is designed for simultaneous detection and differentiation of influenza A, influenza B, COVID-19, and RSV using the compact Co-Dx PCR Pro instrument. The system uses reverse-transcriptase PCR technology to provide decentralized upper respiratory infection test results at the point-of-care or near point-of-care.
Expanding Market Opportunities
According to a Grand View Research report, the respiratory infectious disease diagnostics market was valued at $54.58 billion in 2024, with molecular diagnostics accounting for roughly two-thirds of the total value. North America represents the largest geographical market, and the global market is projected to reach $73.56 billion by 2030, driven by rising adoption of point-of-care diagnostics in settings such as physicians’ offices.
Co-Diagnostics anticipates that clinical testing results may support submissions to other regulatory bodies beyond the FDA, including the Saudi Food and Drug Authority. The company plans to introduce the test into the Indian market through joint venture CoSara Diagnostics, along with platform tests for tuberculosis and HPV that are also nearing clinical evaluation commencement.
The respiratory infectious disease diagnostics market in the Middle East is expanding, influenced by investments in Saudi Arabia and its commitment to improving public health in alignment with Saudi Vision 2030 initiatives.
Co-Diagnostics develops, manufactures, and markets molecular diagnostics technologies for tests designed to detect and analyze nucleic acid molecules. The company uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform, which remains subject to regulatory review and is not currently available for sale.
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