Rapid Diagnostic Systems Announces CE Mark Approval for NaorCov-19 Rapid Molecular Diagnosis of COVID-19
March 25, 2021
Rapid Diagnostic Systems Limited (RDS), www.narodia.com announced today that the company’s NaorCov-19, which is enabling for the first time rapid and scalable saliva based COVID-19 molecular diagnosis, had received the CE-European Conformity Mark approval.
The CE marking confirms that NaorCov-19 meets the requirements of the European Medical Devices Directive, which will allow the selling of the the kits across the European Union and other CE Mark geographies. The company is in process to deliver the first kits into multiple geographies using a network of partners and directly to clients.
Typical use case for the technology are workplaces, schools and university campuses and even on board of airplanes and cruise ships. The platform could be used for surveillance and screening as well as as a gating mechanism in places like airport lounges. Being a molecular diagnostic, the test could also be used in many countries for border control. The kit could easily be adapted later for home use.
The patented NaorCov-19 device uses a unique saliva collection and disposable device, coupled with a rapid molecular diagnostic process, that could be conducted with affordable and light heating devices. It can be used to process locally and rapidly hundreds of samples each hour and without a need for highly skilled personnel.
The testing procedure is easy to operate, with immediate high accuracy results for symptomatic and asymptomatic patients. The kit could be integrated with a cloud and SMS based systems to document the tests and notify the relevant stakeholders.
RDS is a company that is further developing and building its platform, based on core technologies initially developed by a multidisciplinary research team from the Israeli Technion’s Schools of Medicine and Mechanical Engineering, led by Dr. Naama Geva-Zatorsky, who is also a company co-founder. The NaorCov-19 had been tested in a variety of clinical settings at leading medical institutions worldwide. The company is collaborating with MAFAT, the Israeli R&D arm of the Israeli Ministry of Defense.
Dr. Oren Fuerst, co-founder and CEO of the company stated: “The approval is an important milestone in the development of the scalable Naor platform. Our vision is to offer massively scalable molecular diagnostic anywhere, initially for COVID-19. Easy to collect saliva samples, easy handling and processing, easy computerized reporting, all using light and inexpensive equipment that does not require special skills.”