Periodic Reporting for period 1 - Corona-Quick (Rapid and easy- test for Coronavirus infections)
Berichtszeitraum: 2020-08-01 bis 2022-10-31
In the global battle against Coronavirus, SOMAprobes positions itself at the forefront, by creating an innovative approach that is harnessing the virus’ own strategic arsenal for virulence in order to detect its presence at the early stages in asymptomatic or middy symptomatic patients. SOMAprobes has made its mission to develop a revolutionary Coronavirus detection test, Corona@Quick, able to rapidly and robustly detect a nuclease produced by Coronavirus (Nsp15, endonuclease) in 25min, directly from the clinical samples of saliva. SOMAprobes has identified that its technology based on nucleases as biomarkers and oligonucleotide substrates can be efficiently integrated into a lateral flow platform, thus offering a Point of Care (PoC) system for the rapid screening of Coronavirus.
The coronavirus outbreak in 2019 (Cov-19) has challenged the global healthcare system to contain a virus with unprecedented contagious capabilities, with clinical presentations mimicking a viral pneumonia.1 A major aspect for controlling the Coronavirus pandemic is the implementation of tools that allow rapid screening of patients at the healthcare centres and not only. Fast and accurate diagnosis of early infections will facilitate the clinical management of the virus and will improve patients' prognosis. The diagnostic gold standard for Coronavirus is the RNA detection of pharyngeal swab specimen by RT-PCR. However, the limitations of time, need of devices and specialized personnel to perform RT-PCR, combined with the rapid spread and universal susceptibility to the general population, make this diagnostic technique incompatible with the urgent medical needs. Moreover, the number of RT-PCR kits available are limited and the production cannot cope with the high demand. The main objective of this study is to develop a rapid, easy and economical screening test for Coronavirus with the capability to achieve results in 25 minutes, with high sensitivity and specificity. The test will be used to screen asymptomatic or mildly symptomatic individuals, which can risk community transmission to population categories at a higher risk (elderly and individuals with underlying conditions, among others). Corona@Quick is a lateral flow strip test similar to the well-known pregnancy test. Herein, we are aiming to validate the diagnostic accuracy and screening efficacy of Corona@Quick. This strategy could provide the means to prevent and control the disease.
Patients suffering from Coronavirus infection need to stay longer in hospital or quarantine, suffer additional pain and anxiety, and often, entailing significant economic burden for both the patient and the healthcare system. The coronavirus pandemic is a global health emergency, but it is also having major economic effects, sinking stock markets and threatening to send the global economy into recession. SARS-CoV-2 has created the first biological cause of a global economic crisis. Thus, it is imperative to prevent and control this Coronavirus pandemic. Consequently, there is an urgent and unmet clinical need for innovative Point-of-Care diagnostic tools that can reliably identify Coronavirus infections, with a short turnaround time. The development of such rapid diagnostic methods will provide clinical and cost-related improvements in the prevention and management of the Coronavirus pandemic.
The objectives of the SOMAprobes diagnostic kit are:
1) the creation of an LFA detection kit using an oligonucleotide substrate (proprietary technology) from non-invasive saliva samples;
2) To provide an accurate and efficient screening method for testing Coronavirus in 25 min
3) To detect infection through viable virus causing active infection as opposed to the presence of viral remains.
The coronavirus outbreak in 2019 (Cov-19) has challenged the global healthcare system to contain a virus with unprecedented contagious capabilities, with clinical presentations mimicking a viral pneumonia.1 A major aspect for controlling the Coronavirus pandemic is the implementation of tools that allow rapid screening of patients at the healthcare centres and not only. Fast and accurate diagnosis of early infections will facilitate the clinical management of the virus and will improve patients' prognosis. The diagnostic gold standard for Coronavirus is the RNA detection of pharyngeal swab specimen by RT-PCR. However, the limitations of time, need of devices and specialized personnel to perform RT-PCR, combined with the rapid spread and universal susceptibility to the general population, make this diagnostic technique incompatible with the urgent medical needs. Moreover, the number of RT-PCR kits available are limited and the production cannot cope with the high demand. The main objective of this study is to develop a rapid, easy and economical screening test for Coronavirus with the capability to achieve results in 25 minutes, with high sensitivity and specificity. The test will be used to screen asymptomatic or mildly symptomatic individuals, which can risk community transmission to population categories at a higher risk (elderly and individuals with underlying conditions, among others). Corona@Quick is a lateral flow strip test similar to the well-known pregnancy test. Herein, we are aiming to validate the diagnostic accuracy and screening efficacy of Corona@Quick. This strategy could provide the means to prevent and control the disease.
Patients suffering from Coronavirus infection need to stay longer in hospital or quarantine, suffer additional pain and anxiety, and often, entailing significant economic burden for both the patient and the healthcare system. The coronavirus pandemic is a global health emergency, but it is also having major economic effects, sinking stock markets and threatening to send the global economy into recession. SARS-CoV-2 has created the first biological cause of a global economic crisis. Thus, it is imperative to prevent and control this Coronavirus pandemic. Consequently, there is an urgent and unmet clinical need for innovative Point-of-Care diagnostic tools that can reliably identify Coronavirus infections, with a short turnaround time. The development of such rapid diagnostic methods will provide clinical and cost-related improvements in the prevention and management of the Coronavirus pandemic.
The objectives of the SOMAprobes diagnostic kit are:
1) the creation of an LFA detection kit using an oligonucleotide substrate (proprietary technology) from non-invasive saliva samples;
2) To provide an accurate and efficient screening method for testing Coronavirus in 25 min
3) To detect infection through viable virus causing active infection as opposed to the presence of viral remains.
The work performed since the beginning of the project is aligned with the work packages defined in the summary of the project. According to these work packages, these are the objectives achieved so far:
1.- We have made the round of screening of probes to determine the type of substrate preference using relevant clinical samples.
We performed the round of screening and we have identified a specific probe for the coronavirus Nsp15 endonuclease.
We have selected a recombinant NSP15 endonuclease
We have made the integration with an LFA strip and was ready to be tested in real samples
We have developed four product versions to be considered as prototypes that are ready to test in real conditions to select the commercial one.
2.-Clinical validation: We have made four feasibility studies with real samples in hospitals and scouting sites to test our prototypes. Data management and performance are done with the collaboration of a CRO.
3.- Clinical protocol has been designed and validated according to the product claims.
4.- Manufacturing collaboration agreement pending to be negotiated with a partner.
5.- We have implemented the Quality Assessment System implementation.
6.- Dissemination: new website, promotional videos, social network publications press release has been made during this period
1.- We have made the round of screening of probes to determine the type of substrate preference using relevant clinical samples.
We performed the round of screening and we have identified a specific probe for the coronavirus Nsp15 endonuclease.
We have selected a recombinant NSP15 endonuclease
We have made the integration with an LFA strip and was ready to be tested in real samples
We have developed four product versions to be considered as prototypes that are ready to test in real conditions to select the commercial one.
2.-Clinical validation: We have made four feasibility studies with real samples in hospitals and scouting sites to test our prototypes. Data management and performance are done with the collaboration of a CRO.
3.- Clinical protocol has been designed and validated according to the product claims.
4.- Manufacturing collaboration agreement pending to be negotiated with a partner.
5.- We have implemented the Quality Assessment System implementation.
6.- Dissemination: new website, promotional videos, social network publications press release has been made during this period
The SOMAprobes technology together with the Corona@Quick test, which is ready to be deployed in the market, has tremendous value as a powerful tool in the arsenal against emerging pathogens and future pandemics.
The corona-Quick project has allowed SOMAprobes to build up a more solid research structure with important aspects, such as the quality control implemented for all company activities. Importantly, we got the opportunity to participate in and coordinate clinical trials in collaboration with hospitals and clinicians. This has been an extraordinary opportunity for the team and provided a steep learning curve in clinical operations, clinical management, and in general, the relevant knowledge that is needed for translating the company research work into products for the benefit of society.
The main scientific and technological achievement: It is the first time that the detection of nuclease activity as a biomarker is integrated into a rapid test intended to screen and triage populations during a pandemic event.
The test development process, from the identification of the specific oligonucleotide substrate for the virus nuclease to its implementation in a lateral flow test, and to its clinical validation in 4 studies, was filled with ups and downs and experienced very high pressure from the rapid developing COVID-19 IVD market. Nevertheless, the Project contributed to a better understanding of the product development process that goes beyond the scientific milestones.
The corona-Quick project has allowed SOMAprobes to build up a more solid research structure with important aspects, such as the quality control implemented for all company activities. Importantly, we got the opportunity to participate in and coordinate clinical trials in collaboration with hospitals and clinicians. This has been an extraordinary opportunity for the team and provided a steep learning curve in clinical operations, clinical management, and in general, the relevant knowledge that is needed for translating the company research work into products for the benefit of society.
The main scientific and technological achievement: It is the first time that the detection of nuclease activity as a biomarker is integrated into a rapid test intended to screen and triage populations during a pandemic event.
The test development process, from the identification of the specific oligonucleotide substrate for the virus nuclease to its implementation in a lateral flow test, and to its clinical validation in 4 studies, was filled with ups and downs and experienced very high pressure from the rapid developing COVID-19 IVD market. Nevertheless, the Project contributed to a better understanding of the product development process that goes beyond the scientific milestones.