Colorimetric Precision Nanodiagnostics made Fast and Affordable

Project Information

Nano4

Grant agreement ID: 822932

DOI

10.3030/822932

Project closed

EC signature date 20 June 2018

Start date 1 July 2018

End date 31 December 2021

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 028 900,00

EU contribution

€ 1 420 230,00

Coordinated by

NANO4 GLOBAL LDA
Portugal

Periodic Reporting for period 3 - Nano4 (Colorimetric Precision Nanodiagnostics made Fast and Affordable)

Reporting period: 2020-07-01 to 2021-12-31

Summary of the context and overall objectives of the project

There is a need for cost-effective molecular point of care diagnostic tools to provide better healthcare to patients and better agility to the healthcare system. Furthermore, there is the need to extend the limits of molecular diagnostics to the nanoscale.
The market needs a rapid and definitive answer at entry level. It needs a diagnostic that is capable of screening directly and simply hundreds of samples with low infrastructure and untrained professionals, that currently can only rely on the existing infrastructure like peripheral hospital and microscopy centres.
We have developed a nanotechnology-based solution. NANO4 is a fast and user-friendly nano-based diagnostic technology suitable for use at Point of Need. NANO4 represents a highly specific and sensitive nanotechnology for in vitro molecular diagnostics. It uses gold nanoprobes to recognize the complementary DNA/ RNA strand and yield a colour output that allows for quick decision making.
Molecular diagnosis is a multi-million Euro market. Our business objective is to make NANO4 a standard diagnostics technology present at each Point of Need and to become the global leader in nano-based molecular diagnostic technology. Easily accessible fast molecular testing is a tremendous challenge especially when reliable results are needed quickly and cost efficiently.
We defined our go-to-market roadmap for our first disruptive products: NANO4 TB for Tuberculosis, and NANO4 CML for Chronic Myeloid Leukemia, including industrial scale-up and obtaining the CE mark.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

NANO4 Global reached the first 12 months in line with milestones submitted. Relevant objectives completed: set-up of our industrial facility; Scale-up process of production; and Certification of Nano4 Global according to ISO 13485:2016 and 9001:2015. Towards future commercialization, Nano4 Global implemented the first steps for commercial approach. Intellectual Property was associated to PCT application.
In the second year of the project, we proceeded with the clinical validation of NANO4 TB. Due to CoVID-19 pandemic and several lock downs, we were forced to postpone the clinical validation. This third period, we proceeded with the NANO4 CML clinical validation and CE Mark dossier preparation for the launch in 2022. NANO4 Global, currently, is a certified manufacturing and distributor of IVD devices and continue to be an ISO 9001:2015 and ISO 13485 company.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

According to WHO in 2017, 10 million people developed Tuberculosis. Despite all efforts to eradicate TB – like the StopTB initiative coordinated by WHO and FIND, the number of patients increased. In 2017 more than 1.3 million people with TB died.
According to those at the forefront of this epic fight, there is a tremendous need for diagnostic tools. NANO4 technology will have an impact on the diagnostics of Tuberculosis, making it fast, easy, and affordable.
Nevertheless, during the implementation of our project, we had to face a pandemic with a major impact and disruption on the market, were TB activities only towards the end of 2021 have started to resumed as world has focused on CoViD-19.
As planned, at the end of the project, our NANO4 TB diagnostic product is going to be launched in the market as a result of accomplishment of the important milestones: technical and regulatory achievements that allow the product to reach the standards to be in the market.

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