Co-Diagnostics Inc, a molecular diagnostics company with a patented platform for developing molecular diagnostic tests, has received an Australian patent grant for its next-generation polymerase chain reaction (PCR) platform, reinforcing its intellectual property base supporting future manufacturing and commercialization.

The Australian Patent Office granted Patent No. AU2022270084A1, originally filed in May 2022, marking the first granted patent for the company’s new point-of-care PCR platform. The patent provides broad protection in Australia for the proprietary system and methods used in nucleic acid detection and analysis, covering the design and operation of the Co-Diagnostics PCR Pro instrument and test cups. The claims enable high-quality PCR testing outside conventional laboratory settings, supporting decentralized diagnostic manufacturing models.

Dwight Egan, chief executive officer of Co-Diagnostics, said the patent represents an important milestone in securing global protection for the company’s technology as it expands applications for point-of-care PCR testing. He noted that strengthening the global IP portfolio is critical to supporting future manufacturing scale-up and deployment of accurate and accessible PCR diagnostics.

The Australian patent offers strategic protection in a key healthcare market where Co-Diagnostics and potential partners may pursue manufacturing, distribution, or commercialization opportunities. The move also safeguards the commercial potential of the platform’s multiplex assays, including Flu A/B, Covid, and RSV tests, which are currently undergoing clinical performance evaluation.

Designed to deliver laboratory-grade PCR accuracy in a compact and user-friendly format, the Co-Diagnostics PCR platform leverages the company’s proprietary Co-Primers technology. It is intended to support rapid, sensitive, and specific molecular diagnostics across a wide range of infectious disease applications in decentralized and near-patient settings.

The Co-Diagnostics PCR platform, including its home and professional systems, software, mobile application, and associated tests, remains under regulatory review by the US Food and Drug Administration and other global authorities and is not yet available for sale.

Headquartered in Utah, Co-Diagnostics Inc develops, manufactures, and markets advanced molecular diagnostic technologies based on nucleic acid detection and analysis. The company also applies its proprietary platforms to design genetic tests for applications beyond infectious diseases, subject to regulatory approvals.