LONDON--(BUSINESS WIRE)--GeneMe, a leading biotech company based in Gdańsk, Poland has developed “FRANKD” – a fast, scalable and reliable mouth swab test for COVID-19 that is completed on-premises in on average 13-25 minutes with no laboratory involvement. The GeneMe FRANKD test has been independently validated with 100% Sensitivity and 100% Specificity by Gdańsk University of Technology.
FRANKD requires less time to produce a result than the gold-standard RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) reference test recommended by the World Health Organization. With consent, results are automatically issued on to each individual’s secure, free Yoti digital ID app. The test will cost businesses in the region of £10, making it cost-effective to perform mass daily testing and point-of-entry testing at care homes, airports, offices and many other locations.
Dawid Nidzworski Founder and CEO of GeneMe and developer of FRANKD said:
“We are extremely pleased with the quality of the FRANKD test and the contribution it will make towards the fight against the coronavirus pandemic and its damaging effects on public health and society”.
FRANKD is currently in talks with governments and businesses across Europe to roll out millions of tests over the coming months, enabling key industries to test hundreds of thousands of employees daily, to help understand the spread of the virus and to monitor the infection R factor more accurately.
The test uses a patented enzyme rather than the currently scarce reagents used in RT-PCR tests to rapidly produce a definitive and reliable result. FRANKD is therefore scalable with 5m monthly tests expected from August. Use of a portable machine analyser to amplify the virus within the sample ensures high test accuracy. During June and July, FRANKD tests will be processed using hundreds of existing analyser machines, able to handle 90 tests every 30 minutes, but GeneMe expects affordable bespoke machines to be available from August.
What differentiates FRANKD from other viral testing solutions is that it is suitable for mass testing; 90 people can be tested at a time, every 30 minutes with one device, massively reducing the cost of testing. Testing on-premises by trained staff removes delays and the challenge of getting test samples to lab technicians to process. Independent validation of the FRANKD test is underway and European CE regulatory certification is expected by early June.
Testing care workers daily could dramatically reduce the spread of infection within the care home sector and beyond. Testing passengers prior to passing through airport security could also prevent disease spread during passenger air travel, reducing the need for mass quarantine. Testing all hotel guests and employees daily could allow hotels to reopen at significantly lower risk. A specific web application from Yoti will ensure all 90 tests within a batch are uniquely assigned to the correct owner before entering the analyser machine.
Individuals use the secure, free Yoti digital ID app to link themselves to their test and, with consent, the digital test result is automatically added into the tested person’s Yoti. Organisations including the NHS already securely issue digital ID cards using the Yoti app credential management platform. Individuals can present or share their tamperproof, verified details with other parties in seconds - including their test result - whether in person or online, with a tap of a button or scan of a QR code.
Anti-fraud measures are built into Yoti’s reusable digital ID, critically offering much higher trust than is possible with traditional paper and plastic-based identity documents or paper health certificates. Audit receipts are issued securely to both the individual and the recipient individual or organisation when results are shared remotely. The Yoti app is currently available in English, with French, Spanish, Polish and German to be released shortly, followed by further languages.
Kasjan Szemiako - CTO of GeneMe and developer of FRANKD said:
“We chose Yoti because of its security, user interface and reputation. We will share the results of the test directly with Yoti to ensure data privacy and enable user control.”
Robin Tombs - Yoti Co-Founder and CEO said:
“We’re delighted FRANKD has chosen Yoti to enable individuals to manage their COVID-19 test results securely on their phone. Getting the world of business and sport back up and running safely during this coronavirus pandemic is so important. Get FRANKD with Yoti.”
GeneMe develops, registers and produces diagnostic kits for the detection of SARS-CoV-2 and over 240 other pathogens. All kits are based on direct virus RNA detection in a sample.
GeneMe uses a special patented enzyme for virus detection.
Test results were validated by the Gdańsk University of Technology.
Test Sensitivity results show that the average detection time for a sample containing 1 million viral copies was 12 minutes 45 seconds, and for 10 viral copies was 23 minutes 25 seconds. A German study has reported that an COVID-19 infected individual has an average of 670,000 viral copies per swab during the first 5 days of their illness. https://www.medrxiv.org/content/medrxiv/early/2020/03/08/2020.03.05.20030502.full.pdf
The GeneMe FRANKD test requires less time to produce a result than the gold-standard RT-PCR reference test recommended by the World Health Organization.
Test Specificity results show that no false positives were obtained when testing against 4 other coronaviruses.
FRANKD - stands for Fast, Reliable, Accurate, No laboratory and available in a Kit form to be used on-premises Daily.
Dawid Nidzworski one of the Co-founder’s of GeneMe is also the creator of the Institute of Biotechnology and Molecular Medicine (IBMM).
The Institute of Biotechnology and Molecular Medicine (IBMM) is an independent, elite, biomedical research institution. The thematic scope of IBMM activities includes, among others, biotechnology, medicine, diagnostics, molecular biology and material engineering.
More on www.ibmm.pl
Yoti is a digital ID and credential management platform that allows organisations to verify identities and trusted credentials online and in person. Yoti’s products span identity verification, age assurance, document e-signing, access management and biometric authentication.
Yoti is certified to ISO/IEC 27001:2013 for ID Verification Services. Yoti is ISAE 3000 (SOC 2), Type 2 certified for its technical and organisational security processes and is a Secured by Design (Official Police Security Initiative) member company.