Periodic Reporting for period 1 - IRIS-COV (Market Release of a Portable Device for COVID-19 at the Point-of-Care; a Global Diagnostics Approach)
Berichtszeitraum: 2020-11-01 bis 2022-04-30
The current pandemic of the coronavirus, reported first on 31st December 2019 in China, has produced a global alert of unprecedented nature. From the beginning, immediate actions have been put in place by all relevant stakeholders, i.e. local health departments, governments, pharmaceutical companies, global organisations etc., to address the problem as quickly as possible and control the spread of the disease. Large scale testing of symptomatic and asymptomatic citizens has been one of the most effective measures taken by several countries, combined with isolation and tracking. Today, after 17 months from the outbreak, deaths continue to rise in some parts of the world despite the available vaccines while several new variants are already reported. Fear of a new wave of the pandemic together with the ongoing cases worldwide makes the need for developing rapid and accurate diagnostic tools for COVID-19 a global priority, as declared by the WHO.
The current consortium aims to join forces in the battle against the coronavirus by producing mature and robust solutions with immediate impact. The proposal is built around the implementation of an existing and patented device and methodology based on the use of real time quantitative colorimetric Loop-Mediated isothermal amplification (qcLAMP) and detection through a prototpe device named IRIS. This mature methodology, currently having reached the highest technology readiness level (TRL=9) has been proven to be able to detect SARS-CoV-2 in patients’ samples with 97.4% sensitivity and 100% specificity. The main objectives of this proposal are thus the immediate deployment of the device following clinical validation and fast track certification. Arrangements for the large-scale production of the device and reagents will take place in parallel, followed by the provision of a full medical certification for COVID-19 detection directly in crude samples and at the point-of-care (POC). Global uptake of the two certified products and sharing of the project results are important deliverables of the proposal for the current and future epidemics.
The project objectives are to validate and certify a prototype device and two tests (COVID-19 and influenza) as per IVDD (98/79/EC) (Emergency Track Certification Route) for product release in Europe but also globally.
The current consortium aims to join forces in the battle against the coronavirus by producing mature and robust solutions with immediate impact. The proposal is built around the implementation of an existing and patented device and methodology based on the use of real time quantitative colorimetric Loop-Mediated isothermal amplification (qcLAMP) and detection through a prototpe device named IRIS. This mature methodology, currently having reached the highest technology readiness level (TRL=9) has been proven to be able to detect SARS-CoV-2 in patients’ samples with 97.4% sensitivity and 100% specificity. The main objectives of this proposal are thus the immediate deployment of the device following clinical validation and fast track certification. Arrangements for the large-scale production of the device and reagents will take place in parallel, followed by the provision of a full medical certification for COVID-19 detection directly in crude samples and at the point-of-care (POC). Global uptake of the two certified products and sharing of the project results are important deliverables of the proposal for the current and future epidemics.
The project objectives are to validate and certify a prototype device and two tests (COVID-19 and influenza) as per IVDD (98/79/EC) (Emergency Track Certification Route) for product release in Europe but also globally.
During the 18 months of IRIS-COV project, all partners carried out the tasks and activities as defined in the DoA. These included research, engineering, IT, clinical validation, certification, large-scale manufacturing, commercialisation and dissemination and communication tasks. All goals and objectives were achieved.
Objective 1: Validate and certify IRIS device and COVID-19 and influenza diagnostic tests as per IVDD (98/79/EC) (Emergency Track Certification Route) for product release
The registration and consequently the CE marking of the products based on the requirements of the IVDD 98/79 has been fully achieved; consequently, BIOPIX-T was able to obtain the Free Sales Certificates by National Medicines Agency as well as introduce the products and enter to relevant Healthcare Markets, Greece, Cyprus, etc.). All of the products have been properly and lawfully registered/certified as per Annex IIi requirements of 98/79
Objective 2: Design, performance evaluation and certification of a point-of-care diagnostic tool (IRIS) versus COVID-19 and influenza testing as per IVDR (746/2017)
In Relation to 746/2017:
Based on the new transitional period to IVDR the products comply fully to Article 110, which has already described in full detail according to our latest provided deliverable. Furthermore, the Pebble fully complies to IVDR based on its declaration of conformity and has been already registered as IVDR product to the Hellenic Competent Authority - National Medicines Agency (EOF). Additionally, the COV19qcLAMP complies now with the common technical specification MDCG 2021-21.
Objective 3: Dissemination, knowledge and sharing activities
This objective has been achieved through a series of research and commercial communication and dissemination activities, including scientific publications, press reports, articles in commercial and social media, presentations, interviews and video-release. The above activities addressed audiences in Europe, Africa, N. Zealand, Turkey, the USA, India, etc., thus, satisfying the global aspect of our work.
Objective 1: Validate and certify IRIS device and COVID-19 and influenza diagnostic tests as per IVDD (98/79/EC) (Emergency Track Certification Route) for product release
The registration and consequently the CE marking of the products based on the requirements of the IVDD 98/79 has been fully achieved; consequently, BIOPIX-T was able to obtain the Free Sales Certificates by National Medicines Agency as well as introduce the products and enter to relevant Healthcare Markets, Greece, Cyprus, etc.). All of the products have been properly and lawfully registered/certified as per Annex IIi requirements of 98/79
Objective 2: Design, performance evaluation and certification of a point-of-care diagnostic tool (IRIS) versus COVID-19 and influenza testing as per IVDR (746/2017)
In Relation to 746/2017:
Based on the new transitional period to IVDR the products comply fully to Article 110, which has already described in full detail according to our latest provided deliverable. Furthermore, the Pebble fully complies to IVDR based on its declaration of conformity and has been already registered as IVDR product to the Hellenic Competent Authority - National Medicines Agency (EOF). Additionally, the COV19qcLAMP complies now with the common technical specification MDCG 2021-21.
Objective 3: Dissemination, knowledge and sharing activities
This objective has been achieved through a series of research and commercial communication and dissemination activities, including scientific publications, press reports, articles in commercial and social media, presentations, interviews and video-release. The above activities addressed audiences in Europe, Africa, N. Zealand, Turkey, the USA, India, etc., thus, satisfying the global aspect of our work.
Our project had significant impact in the management of COVID-19 epidemic as described below:
Impact #1: Implementing urgently needed diagnostics, in the face of an evolving COVID-19 epidemic
An industrial grade smart device, named Pebble, was designed, manufactured and certified together with an assay for SARS-CoV-2 detection using extracted RNA or directly from swab samples. A good number of Pebble was produced and released to the market by March 2022, accompanied by kits for SARS-CoV2. In that respect, IRIS-COV products were released while the pandemic was still on-going and were implemented by several end-users contributing in the management of the disease at various points.
Impact #2: New assays & their exploitation to develop diagnostic tools for better management of COVID-19
In addition to SARS-CoV-2, an influenza assay was also developed, validated and certified. Overall, having developed a CE marked, certified device and assays is a big asset providing the basis for future fast adaptation of new assays and fast-track development of new tests. Pebble technology is an ideal platform for such fast adaptation due to the generic nature of the test and simplicity in operation. Therefore, IRIS-COV contribution to the better management of COVID-19 and of other respiratory infectious diseases is still relevant and significant and will continue being in the future.
Impact #3: Enhancing Europe’s competitiveness by becoming leaders in the area of diagnostics POC Market.
IRIS-COV project has brought in just 18 months a lab prototype (IRIS) to a commercial device (Pebble) with two accompanying test kits (SARS-CoV-2 and Flu A), all certified as per IVDR (MS1) and pending final approval as per IVDD (MS2). Moreover, it has led to two ISO13485 certified companies (BIOPIX and ENZYQUEST) (MS3 & 4) and a strong partnership with a medical device and healthcare SME provider in S. Africa (Kiara Health) for device and kits production and distribution in sub-Sahara countries (MS8). Achieving the first sales of devices in Europe in October 2021 (MS12) and, hopefully, very soon in S. Africa (MS13), the project has achieved its initial goals and milestones and has already started producing revenue, enhancing European competitiveness in the point-of-care diagnostics market with a global presence. By the end of the project, the Pebble device produced within IRIS-COV project had 120 Pebble devices working all over the world and BIOPIX partner has sold 35K COVID-19 tests. To conclude, BIOPIX-T together with ENZYQUEST SME-partners by delivering Pebble and kits to the end users by M11 contributed in the rapid and early disease-diagnosis and containment of the COVID-19 outbreak. Establishing production lines in Greece and S. Africa has assisted in enhancing the biomedical manufacturing, enzyme’s biotechnology and digital industry sectors in Europe and consequently its competitiveness in the global relevant market.
Impact #1: Implementing urgently needed diagnostics, in the face of an evolving COVID-19 epidemic
An industrial grade smart device, named Pebble, was designed, manufactured and certified together with an assay for SARS-CoV-2 detection using extracted RNA or directly from swab samples. A good number of Pebble was produced and released to the market by March 2022, accompanied by kits for SARS-CoV2. In that respect, IRIS-COV products were released while the pandemic was still on-going and were implemented by several end-users contributing in the management of the disease at various points.
Impact #2: New assays & their exploitation to develop diagnostic tools for better management of COVID-19
In addition to SARS-CoV-2, an influenza assay was also developed, validated and certified. Overall, having developed a CE marked, certified device and assays is a big asset providing the basis for future fast adaptation of new assays and fast-track development of new tests. Pebble technology is an ideal platform for such fast adaptation due to the generic nature of the test and simplicity in operation. Therefore, IRIS-COV contribution to the better management of COVID-19 and of other respiratory infectious diseases is still relevant and significant and will continue being in the future.
Impact #3: Enhancing Europe’s competitiveness by becoming leaders in the area of diagnostics POC Market.
IRIS-COV project has brought in just 18 months a lab prototype (IRIS) to a commercial device (Pebble) with two accompanying test kits (SARS-CoV-2 and Flu A), all certified as per IVDR (MS1) and pending final approval as per IVDD (MS2). Moreover, it has led to two ISO13485 certified companies (BIOPIX and ENZYQUEST) (MS3 & 4) and a strong partnership with a medical device and healthcare SME provider in S. Africa (Kiara Health) for device and kits production and distribution in sub-Sahara countries (MS8). Achieving the first sales of devices in Europe in October 2021 (MS12) and, hopefully, very soon in S. Africa (MS13), the project has achieved its initial goals and milestones and has already started producing revenue, enhancing European competitiveness in the point-of-care diagnostics market with a global presence. By the end of the project, the Pebble device produced within IRIS-COV project had 120 Pebble devices working all over the world and BIOPIX partner has sold 35K COVID-19 tests. To conclude, BIOPIX-T together with ENZYQUEST SME-partners by delivering Pebble and kits to the end users by M11 contributed in the rapid and early disease-diagnosis and containment of the COVID-19 outbreak. Establishing production lines in Greece and S. Africa has assisted in enhancing the biomedical manufacturing, enzyme’s biotechnology and digital industry sectors in Europe and consequently its competitiveness in the global relevant market.