Genedrive POC test17 Feb 2021 22:25
Dear all
Referring back to the Genedrive POC test mentioned in the 22 Oct 2020 rns, have we heard any updates since then? We only have a few weeks to go till the end of Q1, lots of news on all fronts to look forward to....
Stupid question to be asking at this stage I know, but does anyone understand whether the Genedrive POC test is considered to be PCR test, or is it an antigen test like the lateral flow tests currently being used by the Nhs eg Innova etc? One of the sky news headline articles today was in regard to the accuracy of PCR tests versus the speed/point of care convenience of lateral flow tests ...will the Genedrive POC test be the best of both worlds, which will give it a unique advantage over eg POC tests being developed by ODX & partners/AVCT/NCYT etc?
Hoping that by assessing the pros and cons of the various POC tests, will be more likely to be able to predict which ones US/Europe/Uk/rest of world are likely to purchase in bulk...
Thanks for opinions in advance,
Bapuk
Thu, 22nd Oct 2020 07:00
RNS Number : 8438C
Genedrive PLC
22 October 2020
genedrive plc
("genedrive" or the "Company")
Point-of-Care solution to detect SARS-CoV-2 virus in saliva
Development update
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces it has completed the assay design for the Company's Point-of-Care ("POC") solution for COVID-19 testing and is now generating very promising analytical data aligned to market requirements.
The Genedrive® SARS-CoV-2 POC Kit is being designed to detect SARS-CoV-2, the virus causing COVID-19, amplified directly from a saliva sample without the need to extract viral RNA. This expands the potential use areas of the product and importantly, allows for rapid testing to be performed while a patient is present. When running on the Genedrive® POC device the chemistry is detecting a positive SARS-CoV-2 sample in approximately 15 minutes, with fully negative samples taking just over 20 minutes to resolve. The limit of detection is in line with the UK's MHRA Target Product Profile sensitivity requirements.
The Genedrive SARS-CoV-2 POC Kit follows a similar workflow that has already been validated in the Company's Genedrive® HCV-ID Kit which received WHO pre-qualification earlier this year.
The Company is targeting the end of the calendar year for completion of preliminary product evaluations, with full release of the final CE Marked system in Q1 2021 allowing for thorough clinical testing requirements. Additionally, the Company is working to progress to a version 2 of the product, which would accept a similar freeze-dried PCR bead format previously developed for the high throughput Genedrive® 96 SARS-CoV-2 Kit. This will allow for lower production costs and highly scalable manufacturing capacity.