At BIOPIX-T we are pleased to announce that the portable molecular diagnostic platform “PEBBLE” and its compatible diagnostic test for the detection of Coronavirus are now commercially available!
The “PEBBLE qcLAMP Platform“, as its full name is, is the first Greek portable molecular diagnostic device based on LAMP technology (Isothermal PCR), which can be used at the Point-of-Care. It is notified to the EOF (Greek National Organization for Medicines), based on the European Directive 98/79 IVDD and respectively notified to the EU Member States. In addition, the corresponding diagnostic kit which is to be used together with the diagnostic instrument, for the detection of the new Coronavirus, called “COV19 qcLAMP kit“, has been registered with the EOF.
The reliability of the device is comparable to the corresponding laboratory ‘reference devices’, which cost nevertheless tens of times more and cannot be transported to the points of interest. This offers to the responsible authorities an excellent new weapon for management of the pandemic as they will be able to perform rapid (within 30 minutes) and much more reliable molecular tests at a cost comparable to that of rapid tests. Other innovative features of the device are expected to be gradually certified and utilized, such as the ability to perform tests on a saliva sample, without the unpleasant current sampling procedure.
This device is based on research conducted by BIOPIX-T executives at the Institute of Molecular Biology and Biotechnology of the Foundation for Research and Technology – Hellas (IMBB-FORTH) in Crete and perfected within the company, which is based in the Science and Technology Park of Crete (STEP-C), and which has undertaken the commercialization of the device and the diagnostic tests compatible with it, in collaboration with local IVD product distributors around the world.
For the product development and certification process, the company received initial funding from the Patras Science Park (PSP), followed by a full round of funding led by venture capital firm Metavallon VC, with participation from Bulgaria-based Eleven VC and Greek private investors from the healthcare sector.
During the development and continuous and diverse testing related to the safety, usability and accuracy of the device, necessary under European legislation for its certification, a clinical study was caried out at the University Hospital of Heraklion in Crete, which is one of the Greek national Reference Centers for COVID19. Moreover, a sensitivity/specificity assessment study was carried out in an independent certified laboratory in Switzerland, in addition to the initial sensitivity and specificity study of a prototype which was carried out at the Hellenic Pasteur Institute of Athens.
Multiple clinical studies of the IVD Kits for the detection of SARS-CoV-2 and Influenza type A with this device will continue in the next period at University College London Hospital in England, the Institut National de la Santé et de la Recherche in France and the Universite Libre de Bruxelles – University Hospital in Belgium. These studies are funded by the European HORIZON 2020 programme, as one of 23 proposals selected from a total of 454 in a Covid response call, ( https://cordis.europa.eu/project/id/101016083 ).
George Papadakis who leads the company said: “I am very proud of the BIOPIX-T team which has managed, with a lot of hard work and in a really short time, to bring a technology out of the lab and offer it as a functional and reliable product in the market. I would also like to acknowledge that our endeavors towards the complex Clinical Development, Quality and Regulatory clearance Roadmap of our products were endorsed by PKNM Solutions, a Swiss Consultancy firm. BIOPIX-T’s innovative molecular diagnostic device can be a catalyst, giving a very fast, cost-effective and at the same time reliable result to all points of care as well as other points of interest, such as airports, cruise ships, companies, community services, but also hotels, border entry points or immigration hot-spots, etc. ”
The coding of products according to corresponding regulatory databases for the categorisation of medical devices is as follows:
Pebble qcLAMP Platform Categorization:
|EDMA CODE||22 03 05 / Nucleic Acid Processors|
|CND CODE||W0205/ Nucleic Acid Testing Instruments|
|GMDN CODE||62875/ Thermal cycler nucleic acid amplification analyzer IVD, point-of-care|
COV19 qcLAMP kit Categorization :
|EDMA CODE||15 04 40 90 00/ Other Virology – NA Reagents|
|CND CODE||W01050405/ Other Virology – NA Reagents|
|GMDN CODE||64747/ SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)|