BIOPIX-T announced that the portable molecular diagnostic platform “PEBBLE” as well as the compatible with it diagnostic test for the detection of coronavirus, are now commercially available!
The “PEBBLE qcLAMP Platform”, as it is its full name, is the first greek portable molecular diagnostic device based on LAMP (Isothermal PCR) technology, which can be used at the point of care (Point-of-Care), is notified to the National Organization of Medicines, based on the European Directive 98/79 IVDD and respectively notified to the EU member-states. In addition, the corresponding diagnostic set for the detection of the new Coronavirus, which is used together with the diagnostic instrument called “COV19 qcLAMP kit”, has been registered in the National Organization for Medicines.
The reliability of the device is compared with the corresponding “reference devices” of the laboratory, which cost tens of times more and cannot be transferred to the points of interest. This offers the competent bodies an excellent new weapon for the management of the pandemic, since they will be able to carry out rapidly (within 30 minutes) clearly more reliable molecular tests at a cost comparable to that of rapid tests.Gradually, other innovative features of the device are expected to be certified and exploited, such as the ability to carry out 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 completed within the company, which is housed in the Science and Technology Park of Crete (ETEP-K), and which has undertaken the commercial distribution of the device and its compatible diagnostic tests, in collaboration with local DISTRIBUTORS OF IVD products around the world.
For the product development and certification process, the company received initial funding from the Patras Science Park (ECI) and then a full funding round led by the venture capital company Metavallon VC, and was attended by Eleven VC based in Bulgaria and Greek private investors from the healthcare sector.
During the development of continuous and varied tests related to the safety, usability and fidelity of the device, necessary according to the European Legislation for its certification, the device completed a clinical study at the University Reference Center for COVID-19 in Heraklion (PA.G.N.I.) / CRETE, as well as the sensitivity/specialty assessment study in an independent certified laboratory in Switzerland, in addition to the initial sensitivity and fidelity study at the Pasteur Foundation of Athens.
Within the next period, multiple clinical studies of the IVD Kits Forensic Devices for the detection of SARS-CoV-2 and influenza A with this device will continue at the University College London Hospital in England, the Institut National de la Sante et de la Recherche in France and the Universite Libre de Bruxelles – University Hospital in Belgium. These studies are funded on behalf of the company by the Horizon 2020 European Framework Program, as one of the 23 proposals selected from a total of 454 to deal with the pandemic.
“I am very proud of the BIOPIX-T team, which managed with a lot of hard work and in a really very short time, to get a technology out of the laboratory and offer a functional and reliable product on the market. I would also like to acknowledge the continuous and systematic support we received from the Swiss consulting firm PKNM, during the complex process of clinical development and quality and regulatory compliance. Biopix-T’s innovative molecular diagnostic device can help catalytically, giving a very fast, economical and at the same time reliable solution to all points of care as well as other points of interest, such as airports, cruise ships, companies, services of public benefit interest, but also in hotels, border entry gates or migratory Hot-Spots, etc.”, said George Papadakis who leads the company.