Periodic Reporting for period 2 - LungCARD (Blood test for clinical therapy guidance of non-small cell lung cancer patients)
Période du rapport: 2019-01-01 au 2022-10-31
The LungCARD project is dedicated to develop a blood test for clinical therapy guidance of non-small cell lung cancer (NSCLC) patients.
Lung cancer is the most common cancer worldwide. NSCLC alone make up about 75% of all lung cancers and most hospitals currently test all NSCLC patients for EGFR mutations (pharmacogenomics) for treatment decision (personalised medicine) – i.e. patients with mutation(s) in EGFR gene should receive a EGFR-Tyrosine Kinase Inhibitor (TKI) drug (e.g. afitinib) treatment; while those that do not present mutations in such gene, should be treated with chemotherapy.
Currently, the laboratories use PCR and Sanger sequencing technologies to perform the EGFR analysis from tumour biopsies - Fixed Paraffin Embedded (FFPE) samples.
The occurrence of clinical important mutations in the EGFR gene in Lung cancer patients varies in terms of race; it is around 10% in Caucasians and can reach 30% in Asians. Still, some patients (e.g. 30% in UK) may never get histological confirmation because they are too sick to make a biopsy. Furthermore, the results obtained with current methods still present low quality, mainly due to poor quality/low yield of DNA extracted from FFPE samples.
The point-of-care diagnostics market is witnessing significant growth, owing to the increasing usage of POC tests that can rapidly diagnose diseases. As an example, lung cancer segment is expected to hold a significant share in the market. Companion diagnostic tests (CDXs) are considered mandatory in decision-making for treatment with targeted therapies in lung cancer.
The main project’s goal is to benefit citizens, through the development, improvement, integration and validation of the LungCARD system with LAMP technology and development of a software for automatic reporting clinical results.
LungCARD project aims to go further, by putting together a global and unique network of multidisciplinary scientists for exchange of knowledge and research training focused on non-small cell lung cancer.
Lung cancer is the most common cancer worldwide. NSCLC alone make up about 75% of all lung cancers and most hospitals currently test all NSCLC patients for EGFR mutations (pharmacogenomics) for treatment decision (personalised medicine) – i.e. patients with mutation(s) in EGFR gene should receive a EGFR-Tyrosine Kinase Inhibitor (TKI) drug (e.g. afitinib) treatment; while those that do not present mutations in such gene, should be treated with chemotherapy.
Currently, the laboratories use PCR and Sanger sequencing technologies to perform the EGFR analysis from tumour biopsies - Fixed Paraffin Embedded (FFPE) samples.
The occurrence of clinical important mutations in the EGFR gene in Lung cancer patients varies in terms of race; it is around 10% in Caucasians and can reach 30% in Asians. Still, some patients (e.g. 30% in UK) may never get histological confirmation because they are too sick to make a biopsy. Furthermore, the results obtained with current methods still present low quality, mainly due to poor quality/low yield of DNA extracted from FFPE samples.
The point-of-care diagnostics market is witnessing significant growth, owing to the increasing usage of POC tests that can rapidly diagnose diseases. As an example, lung cancer segment is expected to hold a significant share in the market. Companion diagnostic tests (CDXs) are considered mandatory in decision-making for treatment with targeted therapies in lung cancer.
The main project’s goal is to benefit citizens, through the development, improvement, integration and validation of the LungCARD system with LAMP technology and development of a software for automatic reporting clinical results.
LungCARD project aims to go further, by putting together a global and unique network of multidisciplinary scientists for exchange of knowledge and research training focused on non-small cell lung cancer.
WP1 (ORGANISATION AND MANAGEMENT): The LungCARD RISE project started with the Kick-off and General meetings. The main project´s rules, including a Consortium Agreement, were presented by LungCARD Coordinator Dr. Orfeu Flores, Scientific Coordinator Dr. Carla Clemente and Project Manager Dr. Helena Gonçalves. The Mid Term Meeting occurred at Geneva on the 11th April, 2018 with the participation of the Consortium and European Commission.
On RISE 2018 Coordinators’ Day the LungCARD project manager Dr. Helena Gonçalves was invited to give testimonial about Ethics issues and how to handle them during a RISE project.
Due to COVID-19 Pandemic, the secondments plan was extended for a total duration of 70 months.
WP2 (CURRENT CLINICAL PRACTICES LANDSCAPE): Secondments were mainly focused in know-how exchange, available resources (e.g. equipments) and acquiring a global knowledge of current clinical practices related to Lung Cancer pharmacogenomics and therapy. The data associated with research and clinical practices in Lung cancer from 18 countries across 5 continents was published (https://jbuon.com/archive/24-1-11.pdf).
WP3 (FREEDOM-TO-OPERATE IN SEVERAL COUNTRIES): Information about legal regulations and practice regarding the NSCLC diagnostics and treatment, with the emphasis on targeted therapy in beneficiaries partners’ countries was collected (included in the report of protocol ID VI.1). Intelectual property rights (IPR) related to LungCARD system are planned to be assessed in next coming years at the country of each participant.
WP4 (RESEARCH FOR DEVELOPMENT OF LUNGCARD SYSTEM): The WP4 of LungCARD project aims to develop a LungCARD system used to generate the DNA target regions (biomarkers) associated with the selection of therapy in NSCLC from blood samples and automatic report of results (clinical report).
WP5 (LUNGCARD SYSTEM VALIDATION): The performance of LungCARD system for the detection of the mutation in exon 19 of the EGFR gene (E746-A759del) was assessed by an in-house analytical validation at STAB VIDA (including inter and intra-batch reproducibility, limit of detection (LOD) assessment and storage stability analysis) followed by a clinical validation with cfDNA samples from NSCLC patients performed at clinical partner's laboratories.
WP6 (LUNGCARD IMPLEMENTATION IN SEVERAL COUNTRIES): During the secondments STAB VIDA gave access to the background necessary to understand both the technological development and the scientific principle behind the project. The secondees were trained on the use of Doctor Vida Pocket and participated on the assay development process in order to adapt this technology to different sample types (plasma whole blood and extracted RNA).
WP7 (COMMUNICATION, DISSEMINATION & KNOWLEDGE TRANSFER): The secondees are encouraged to attend/present workshops, seminars and conferences in the relevant topics for the project (e.g. LAMP, lung cancer disease, etc). EU funds were acknowledged in all the activities performed by LungCARD partners/beneficiaries.
WP8 (Ethics Requirements): Fully accomplished already. Also an independent Ethics Adviser was appointed to oversee the implementation of the ethical concerns involved in this research.
On RISE 2018 Coordinators’ Day the LungCARD project manager Dr. Helena Gonçalves was invited to give testimonial about Ethics issues and how to handle them during a RISE project.
Due to COVID-19 Pandemic, the secondments plan was extended for a total duration of 70 months.
WP2 (CURRENT CLINICAL PRACTICES LANDSCAPE): Secondments were mainly focused in know-how exchange, available resources (e.g. equipments) and acquiring a global knowledge of current clinical practices related to Lung Cancer pharmacogenomics and therapy. The data associated with research and clinical practices in Lung cancer from 18 countries across 5 continents was published (https://jbuon.com/archive/24-1-11.pdf).
WP3 (FREEDOM-TO-OPERATE IN SEVERAL COUNTRIES): Information about legal regulations and practice regarding the NSCLC diagnostics and treatment, with the emphasis on targeted therapy in beneficiaries partners’ countries was collected (included in the report of protocol ID VI.1). Intelectual property rights (IPR) related to LungCARD system are planned to be assessed in next coming years at the country of each participant.
WP4 (RESEARCH FOR DEVELOPMENT OF LUNGCARD SYSTEM): The WP4 of LungCARD project aims to develop a LungCARD system used to generate the DNA target regions (biomarkers) associated with the selection of therapy in NSCLC from blood samples and automatic report of results (clinical report).
WP5 (LUNGCARD SYSTEM VALIDATION): The performance of LungCARD system for the detection of the mutation in exon 19 of the EGFR gene (E746-A759del) was assessed by an in-house analytical validation at STAB VIDA (including inter and intra-batch reproducibility, limit of detection (LOD) assessment and storage stability analysis) followed by a clinical validation with cfDNA samples from NSCLC patients performed at clinical partner's laboratories.
WP6 (LUNGCARD IMPLEMENTATION IN SEVERAL COUNTRIES): During the secondments STAB VIDA gave access to the background necessary to understand both the technological development and the scientific principle behind the project. The secondees were trained on the use of Doctor Vida Pocket and participated on the assay development process in order to adapt this technology to different sample types (plasma whole blood and extracted RNA).
WP7 (COMMUNICATION, DISSEMINATION & KNOWLEDGE TRANSFER): The secondees are encouraged to attend/present workshops, seminars and conferences in the relevant topics for the project (e.g. LAMP, lung cancer disease, etc). EU funds were acknowledged in all the activities performed by LungCARD partners/beneficiaries.
WP8 (Ethics Requirements): Fully accomplished already. Also an independent Ethics Adviser was appointed to oversee the implementation of the ethical concerns involved in this research.
The LungCARD technology has evolved from microfluidic to LAMP and produced a CE-IVD product: Doctor Vida Pocket targets in less than 1 h, in a fully point of care mode, to faster identify the treatment of lung adenocarcinomas.
Doctor Vida is a highly innovative portable, handheld device for isothermal nucleic acid amplification of genetic biomarkers. Operated from any smartphone in a clinical or research setting, but also at home, at the office, etc.
Doctor Vida is being marketed for COVID19 and lactose intolerance tests. It is under clinical trials for point of care EGFR testing of NSCLC (as a companion diagnostic), HIV testing, HPV testing, Zika testing (viral load), gluten intolerance, legionella and veterinarian applications.
Doctor Vida Pocket is the smallest portable PCR device for diagnostics of COVID-19 and other diseases, already in the market, CE-IVD, fully developed and ISO 13485 manufactured by STAB VIDA. It is unique and all-in-one testing cycle: kit for sample collection, reagents for isothermal DNA/RNA amplification and detection, pocket-sized device and an APP that delivers the final patient's diagnostics report, in less than 1 hour.
Doctor Vida is now in all continents and recently started business with a distributor for Asia, selling already to Indonesia and for other countries within the region. The video will help better understand our Doctor Vida technology.
https://www.youtube.com/watch?v=lfibWgPFCNc
Doctor Vida is the smallest and portable PCR lab in the world easy to use anywhere (e.g. boat, island, mountain, etc), contributing for EU strategic autonomy and also the image of EU as technology powerhouse. Moreover, Doctor Vida is environmental friendly as well, the costs of production of uncapitalized reagents, the recycling of the plastic packaging of these reagents and environmental impact associated with testing migration are much higher than with the Doctor Vida point of care / laboratory on a phone.
Doctor Vida is a highly innovative portable, handheld device for isothermal nucleic acid amplification of genetic biomarkers. Operated from any smartphone in a clinical or research setting, but also at home, at the office, etc.
Doctor Vida is being marketed for COVID19 and lactose intolerance tests. It is under clinical trials for point of care EGFR testing of NSCLC (as a companion diagnostic), HIV testing, HPV testing, Zika testing (viral load), gluten intolerance, legionella and veterinarian applications.
Doctor Vida Pocket is the smallest portable PCR device for diagnostics of COVID-19 and other diseases, already in the market, CE-IVD, fully developed and ISO 13485 manufactured by STAB VIDA. It is unique and all-in-one testing cycle: kit for sample collection, reagents for isothermal DNA/RNA amplification and detection, pocket-sized device and an APP that delivers the final patient's diagnostics report, in less than 1 hour.
Doctor Vida is now in all continents and recently started business with a distributor for Asia, selling already to Indonesia and for other countries within the region. The video will help better understand our Doctor Vida technology.
https://www.youtube.com/watch?v=lfibWgPFCNc
Doctor Vida is the smallest and portable PCR lab in the world easy to use anywhere (e.g. boat, island, mountain, etc), contributing for EU strategic autonomy and also the image of EU as technology powerhouse. Moreover, Doctor Vida is environmental friendly as well, the costs of production of uncapitalized reagents, the recycling of the plastic packaging of these reagents and environmental impact associated with testing migration are much higher than with the Doctor Vida point of care / laboratory on a phone.