Green Nanotech Tools

The future of healthcare management is based on the capability to prevent, predict and personalize the management of pathological conditions. In such a context, the Diamante Srl mission is to become the global research, development production and market leader of new and innovative reagents meant to be used in diagnostic tests and in therapeutics, paradigms and solutions for autoimmune and infectious diseases.

Diamante is launching on the market an innovative reagent for a prompt, precise, and definitive diagnosis of Sjögren Syndrome (SjS) with a simple blood sample. The product is based on the use of a novel biomarker (patent granted) that allows early, highly-specific, and non-invasive disease detection, exploiting a cost-effective and eco-friendly production system. 

Using the same technology, Diamante is currently developing a new kit for sero-negative RA and also for the Covid-19. Furthermore, those nanomaterials have a great potential also in the therapeutic field. 

Considering Sjogren, our target market are the 2.5 million potential SjS patients/year worldwide that need this diagnostic test. This market were evaluated equal to 3 billion/€ in 2018 (CAGR: 6%). 

Our target market will increased by: patients already diagnosed will take the test again at least once in their lifetime; to be part in the general screening for autoimmune diseases, that is the first diagnostic step for all potential autoimmune disease patients; current prevalence is not the real considering the missed diagnoses. 

Considering AR, the prevalence varies between 0.3% and 1% and is more common in women and in developed countries; within 10 years on onset, at least 50% of patients in developed countries are unable to hold down a full-time job.

Considering Covid-19, this kit could be helpful mainly in the poorest countries, because of the low cost and the efficiency of the production in plants. 

Our technology exploits the use of plant viruses that can be thought as self-replicating proteinaceous nanomaterials, naturally compatible with plant hosts. They are extremely stable and can be easily, efficiently and cost-effectively produced at high titres in plants.

Plants are the ideal production hosts for protein-based nanopharmaceuticals because of their intrinsic safety for humans and animals and higher eukaryotic architecture making them suitable for the production of complex proteinaceous molecules that can’t be expressed efficiently as active assemblies in microbial or mammal cell

The use of plant viruses engineered results in the higher sensitivity of viral particle-based assay vs. the one based on chemically synthesized. This means that they could be use in the creation of diagnostic kit and treatments. Diamante has already developed a blood test for Sjögren Syndrome using the ELISA plates. We are developing the same test for another autoimmune disease (RA) and for COVID19.   

For diagnostic kits we started from two diagnosis orphan diseases: SjS and sero-negative rheumatoid arthritis (RA).

We have created a 2 hours blood SjS test compared to the current 4-year wait. SjS is an autoimmune disease that affects predominantly women, 9 to1, and is characterised by the self- destruction of lachrymal and salivary glands leading ultimately to mouth and eye dryness and to several other severe discomforts. Due to the absence on the market of a single diagnostic test, this would eliminate the fragmentation of the tests performed to obtain a correct diagnosis. Furthermore, for RA, sero-negative patients do not have at the moment reliable diagnostic markers.

This means easy diagnosis, avoiding unnecessary and invasive visits (like saliva biopsy) and the opportunity to live a normal life using the correct treatments.

For Covid 19, this means the possibility to have a new diagnostic tool in a shorter amount of time and supporting the vaccine development. 

We can produce tools in the shortest amount of time developing new materials usablle as reagents in diagnostic and therapeutic approaches. Our technology is environmentally friendly and cost-saving (- 80% costs). We are a team of determined young women trying to do what most people may think would not be possible without buying into the so called safe course. We feel that it is possible to change and have an impact through research and diligent efforts in a methodical way. Given the opportunity, we will use every ounce of energy to turn our product into a life changing solution

What makes us more innovative is that we can produce versatile and practical tools in the shortest amount of time to develop new materials that may be used as reagents in diagnostic and therapeutic approaches. Those materials have been recently used as building blocks for diagnostic kits and for powerful therapeutics (Zampieri et al., 2020). We have created a 2 hours blood SjS test compared to the current 4-year wait. Due to the absence on the market of a single diagnostic test, this would eliminate the fragmentation of the tests performed to obtain a correct diagnosis. Furthermore, for RA, sero-negative patients do not have at the moment reliable diagnostic markers. Our technology is environmentally friendly and cost-saving for the health care system (less than 80% costs). Considering SjS kit, nowadays our direct competitor is the current diagnostic pathway. The future potential competitors are companies focused on the same diagnostic field and other research centers that are still in R&D stage. 

Considering the scientific literacy, the IP, the clinical trials and the pahrma-pipelines, this application is unique and there aren’t other research projects currently focused on the same biotechnological solution.  Our scientific network permits us to be in contact and monitor the other worldwide research groups focus on autoimmune diseases and in general on molecular farming technology. 

Moreover, there aren’t other companies that is developing a plant-based technology that can be used to obtain a result like our kit considering the specificity and the sensibility of the diagnoses.

Our technology exploits the use of plant viruses that can be thought as self-replicating proteinaceous nanomaterials, naturally compatible with plant hosts. They are extremely stable and can be easily, efficiently and cost-effectively produced at high titres in plants. Plants are the ideal production hosts for protein-based nanopharmaceuticals because of their intrinsic safety for humans and animals and higher eukaryotic architecture making them suitable for the production of complex proteinaceous molecules that can’t be expressed efficiently as active assemblies in microbial or mammal cells. The use of plant viruses engineered results in the higher sensitivity of viral particle-based assay vs. the one based on chemically synthesized. This means that they could be use in the creation of diagnostic kit and treatments. Diamante has already developed a blood test for Sjögren Syndrome using the ELISA plates. We are developing the same test for another autoimmune disease (RA) and for COVID19.

Diamante own the exclusive perpetual licence on the Granted Patent (International Pubblication Number WO 2016/194014 A1)  that cover the application of this technology for the diagnoses of the Sjögren Syndrome. 

Diamante has internationally extended this Patent and now since 2019 it has been granted in Europe, Us,  Canada and others minority countries. 

Those materials have been recently used as building blocks for diagnostic kits and for powerful therapeutics (Zampieri et al., 2020)

We expect to introduce the kit in 2021. This will have an important impact on:

- current patients, they could have an important confirm regarding their health status;

- possible new patients, they could avoid gland biopsy (no all the people could have the access to this test, because of the cost and moreover because of the negative consequences that this test could have) and they could avoid unnecessary visits and start the correct treatment sooner. This mins avoid other negative consequences cause by the evolving of SjS.

- health care system, saving a lot of money and giving more access on the tests.

People will have a better life.

The same effect will be also the the RA.

Considering Sjogren, we will serve 1.800.000 people during the next 3 years.

Considering RA, this numbers could be double in the next 5 years.

Our goals are:

- obtaining the CE Mark (by October 2020)

- close the first distribution agreement (by December 2020)

- start the production (2021)

- start selling the product (2021)

- conclude the scientific validation for the RA kit (2020)

- conclude the scientific validation for the Covid kit (September 2020)

- set a new production lab (December 2020)

- introduction in the diagnostic pathway of our kits

- financial difficulties 

- technical problem in the setting of the new kits

- request a support by the scientific committee, Key opinion leader, associations, foundations. We are currently working on that

- finding an investor or obtaining new grants

- request a support by external consultant. 

We are 6 full-time people

Scientific Experience, good network

Our industrial partner is Euroimmun Italia srl (https://www.euroimmun.it), an international provider of medical laboratory products, mainly engaged in the fields of autoimmune and infectious diseases. With them we are revalidating our prototypes and speeding up the process for obtaining the CE certification.Collaborate with Euroimmun means: i.the opportunity to successfully enter into the markett, ii. to serve customers better, iii. to reduce NPD (New Product Development) costs, risks, and time.

The use of plants as bioreactors for the sustainable production of nanoparticles based on modified plant viruses could have lots of different applications in disease diagnosis and also in the therapy. 

Considering that, our business model is a mix of: 1.the product development and commercialization as a supplier, 2. Asset creation & out-licensing. 

We follow the first model in the diagnostic field: we invest our own funds up-front to R&D and create proprietary diagnostic assets (reagent with diagnostic application). We complete the late-stage development work for commercializing creating the final product (as a manufacturer) and gaining the regulatory authorizations to commercialize the product worldwide. We will sell the kit to international distributors.

We follow the second model in the therapeutic field: We invest in R&D and create proprietary therapeutic assets for exclusive licensing to larger biopharmas. The latter then become fully responsible for completing later-stage clinical trials, manufacturing scale-up, regulatory approval and commercialization.

Revenues Assumptions:

• Price per SjS kit: € 200
• SjS kit market launch: January 2021
• SjS kits sold in 2021: n. 15.000
• SjS kits sold in 2022: n. 40.000

We are in contact with the first international distributor (Euroimmun).

Costs Assumptions:

Cost of sales: 50% (2021),  40% (2022 - due to economy of scale)

Main costs: assembling the kit (in outsourcing. We are negotiating with a manufacturer company)

Marketing Campaign: € 50.000 (2020/2021)

Fixed Assets:

New lab setting: € 300.000

New lab capacity: 50.000 kit/year

Human Resources:

Due to the scalability of the reagent production, we need only three full time people to double the capacity

We are committed women entrepreneurs heading businesses with the potential to grow significantly in the years to come. We are a team of determined and high skills people trying to do what most people may think would not be possible. Solve is a unique opportunity for us to take our company to the next level.

We want to be part in the challenge of growing entrepreneurship, mainly in the scientific field. It’s really hard to build a company if you don’t have an ecosystem that supports you and people that think would not be possible. Be part in the Solve’s network means have the possibility to do that.

- to start the distribution outside the Europe;

- to find an investor;

- to impruve our awareness