An over-the-counter RT-PCR system to detect infectious diseases

The Covid-19 pandemic made clear the global need for rapid, accurate and accessible at-home testing. CO-Diagnostics (Co-Dx) presents its PCR platform, Co-Dx PCR Home, to allow for easy and non-invasive diagnosis at home or in clinics.

The Co-Dx PCR Home is an inexpensive sample-to-answer PCR platform that is capable of detecting a variety of infectious diseases in less than 30 minutes. It is intended to be sold for home use over the counter (OTC) or at point-ofcare (POC) facilities like rapid-care clinics, pharmacies and other lowresource settings.

At Co-Dx, the goal is to bring revolutionary lab-grade PCR testing capabilities to everyone. Developed by Co-Dx’s world-renowned scientists, the PCR platform offers gold standard PCR testing anywhere – at home, the office, at school – since no lab is required to analyse the results. Using disposable cartridges and smartphone connectivity, the PCR Home is a revolutionary new way to keep you and your loved ones safe from infectious diseases.

Once a non-invasive sample is collected, the PCR Home performs sample treatment, RT-PCR and DNA melting analysis. Automated analysis then determines whether a pathogen has been detected and immediately shares the information with the patient, health care providers and public health agencies if needed.

What makes the Co-Dx PCR Home unique

The PCR Home is an inexpensive platform for diagnosing infectious diseases from anywhere. The system delivers highly sensitive and specific results by utilising gold-standard PCR testing. With an innovative design and a focus on scalable manufacturing, the platform enables high-quality testing at a price that is comparable to antigen tests.

Users control the PCR Home via an app on a Bluetooth-enabled device, like a phone or tablet. Encrypted data from completed tests are transmitted to the cloud for real-time analysis. Results are then returned to the user and may also be sent to the patient’s healthcare providers. De-identified data can also be made available to public health agencies, enabling epidemiology in real time.

Developmental phase

Co-Dx is currently performing clinical evaluations of the PCR Home with an assay for SARS-CoV-2. The company believes a multiplex assay for Flu A, Flu B, RSV and SARS-CoV-2 will enter clinical evaluations in the Autumn of 2023.

Performance data

The limit of detection of the assay, as well as the clinical sensitivity and specificity are being determined. Preliminary analysis of the data shows that the PCR Home system has sensitivity and specificity comparable to existing FDA cleared assays.

Clinical impact

Co-Dx’s PCR Home brings the quality and capabilities of reverse transcription PCR to anyone, anywhere. This level of accessibility, affordability and connectivity closes many of the gaps that were identified during the Covid-19 pandemic, including testing compliance with social distancing and quarantine guidelines, and data and surveillance issues.

In-home testing provides patients with convenient and comfortable testing while reducing hassles that have historically accompanied PCR-based diagnostics.

Future advances

Additionally, the use of cloud-based analysis can provide testing results to various medical and public health professionals to enable prompt patient treatment and consultation, as well as dissemination of data to promote a swifter health response. On-going evaluations by Co-Dx will dial in the best methods for collecting data from patients to send to providers for final diagnosis and treatment. ­