Company insight
An over-the-counter RT-PCR system to
T
he 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-of- care (POC) facilities like rapid-care clinics, pharmacies and other low- resource 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
24
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.
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.
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
“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.”
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.
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. ●
www.codiagnostics.com Practical Patient Care /
www.practical-patient-care.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61
