30th April 2021 Editorial by: Paul Carton
LAMP Technology Makes Saliva-Based POC COVID-19 Testing Simple & Reliable
C4Diagnostics has recently received CE-marking for a point-of-care molecular RT-LAMP test (C4COVID-19 Human™) that detects SARS-CoV-2 RNA from a patient’s saliva sample and returns a result in 30 minutes. The test is designed to pick up the UK, Brazil, and South Africa variants and showed a sensitivity of 86% and a specificity of 97.5% in a recent clinical study.
In this interview with C4Diagnostics CEO Younes Lazrak, he describes the key factors required to bring a rapid saliva-based test with high performance to the market, gives examples of where it's currently being used in the field, reasons for gene target choice, and the options available for customers.
Q.In what settings do you see your test being used?
Younes: The C4Covid-19 Human test gives a rapid and reliable answer to whether or not a person is infected by SARS-CoV-2. Its use is ideal for situations where you suspect an infection and need to reliably rule out this hypothesis, such as with contact cases or for people showing symptoms.
Some of our clients are industrial companies keen to hinder any COVID-19 outburst and propagation on their site. Those sites generally have an occupational health team that is in charge of ensuring the safety of people working on-site.
Moreover, our kit and its apparatus are compact, light, and portable. C4Covid-19 Human has been designed for in-field use whilst offering a quality of analysis comparable to that of the clinical laboratory.
One of our clients is a luxury cruise company that, when at sea, must be able to autonomously track down COVID-19 whenever there is a suspicion of infection. We also have ongoing discussions with French authorities regarding the deployment of our test on school campuses for instance. Our test could also be implemented in pharmacies. The test is easy to handle and has to be performed by medical or laboratory staff trained to operate test using our tutorial.
Q. What are the capital costs involved with the portable reader – can it communicate results directly to patient and healthcare provider? Does it have full result traceability and storage capacity?
Younes: The reader-analyzer costs about 7000 euros and can either be bought or rented. The C4Covid-19 Human kit is packaged with 10 tests with an average cost of 35 euros per test.
The kit is user-friendly and the results are readable on the front end of the reader-analyzer 20-30 minutes after the saliva sampling. They can be easily exported via a USB flash drive.
Q. The EU is introducing a health passport system for international travel. This passport will allow a person to travel provided they can prove they have received a negative result from a nucleic acid or rapid antigen test, or have been vaccinated. Your test is designed to detect the RdRP and N genes, why did you choose these targets of the viral genome? And How is your test able to guarantee it will pick up all present & future variants?
Younes:In accordance with the World Health Organization recommendations, the C4Covid-19 Human test includes two viral targets (RdRP and N genes). The targeted sequences are common to the native form of the virus ("wild-type") as well as its known variants, notably English, South African, and Brazilian. The patented primers used in the test were invented by the Institut Pasteur's Urgent Response to Biological Threats (CIBU) team, led by Dr. Manuguerra, and licensed to C4Diagnostics. The double targeting of genes RdRP and N allows a very high specificity of our test.
Q.A saliva sample instead of the intrusive nasopharyngeal swab method has many advantages, such as speed and also being patient-friendly. However, not many companies have managed to bring an accurate saliva-based test to market. How have you overcome the limitations of saliva samples with LAMP technology?
Younes: Developing a user-friendly rapid test with high performance was quite a challenge but it’s part of our company’s DNA. We believe that these types of diagnostic tests are game-changers for patient care.
It required months of research and development at C4Diagnostics. In order to reduce development time and costs, we reached out to skilled partners such as Institut Pasteur. Our IVD test is a combination of several patented technologies, secret know-how, and optimized processes: the primers, the apparatus, the LAMP technology, the sample storage, and pre-analytical processing.
Pre-analytical processing is actually key to global performances and may not have been properly taken into account by others. The protocol has a few tweaks because of the saliva matrix that contains a lot of enzymes that could harm the viral RNA. We turned to LAMP technology because it is much faster to handle. The fact that we have optimized the sample treatment and work with highly specific primers gives an end result with a level of performance close to that of the RT-PCR on NP swabs, which is the gold standard.
Q. You are currently in the final stages of bringing the product to market, when do you expect your test to be available? Can clients pre-order now or request a demo?
Younes: Our test is now CE-approved and we have already started to market it. Clients can order it from our website as we directly manufacture and distribute the C4Covid-19 Human IVD test, and distribute the reader-analyzer and the needed additional small equipment. We have a demo tutorial for its use and a brochure. Clients can reach out to our sales team for a demo.
Prior to that, he worked in the in vitro diagnostics industry, at Ipsogen and then at Qiagen, where his main responsibilities were in & out-licensing and managing the industrial property strategy. He then moved to business development and strategic alliances positions. Younes Lazrak holds an Executive MBA from the University of Würzburg (Germany) and an MSc from the University of Strasbourg and INSA Strasbourg (France)
Date Published: 30th April 2021
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