Scope Fluidics, a NewConnect-listed biotechnological company, owner of innovative medical diagnostics projects, has updated the schedule of work on its two new devices. The company announced that the work on the PCR|ONE system will be completed in mid-2020, as planned, whereas the BacterOMIC system will be ready 18 months sooner than originally expected (estimate certification in mid-2021). Scope Fluidics decided to manufacture individual elements of the system for the pre-registration tests on its own, thanks to which some of the related costs will be significantly lower.
The change in the project timeline accelerates the development process in relation to both devices. Such an enhancement has been possible thanks to the dynamic growth in the competences of the team and state-of-the-art technical resources at Scope Fluidics.
We have manager to build a team of top-class experts, whose scientific potential is supported by the Advisory Committee. We also have relevant equipment and know-how. We are ready to undertake the industrialization phase for both our current projects on our own, in such a way as to satisfy the registration requirements, said Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.
Launching Scope Fluidics’ own production of chips and analyzers that are necessary to perform pre-registration tests of the two systems is one of the key changes. Independent manufacture of these components instead of outsourcing it to third parties will result in a significant cost reduction, more efficient control of intellectual property, as well as better control over timely completion of key project stages.
We are keeping the originally planned certification date for the PCR|ONE device around mid-2020. The system may even be commercialized earlier, but the market practice shows that such transactions are completed soon after certification, comments Szymon Ruta, Member of the Board and CFO of Scope Fluidics.
The updated schedule of work for the PCR|ONE system assumes that the device will be ready for another series of tests in Q2 2019. For this stage, three devices will be made, along with injection molds for chip production. Moreover, a pilot line for filling the microfluidic chips will be launched. A number of chips with reagents will be produced for the second series of pre-validation tests, which will be performed in Q3 2019 and Q1 2020 on several hundred of samples, with a view to reveal the current state of PCR|ONE technological development and confirm the readiness of the system to start formal registration testing. Scope Fluidics’ own production of chips and analyzers will be launched, and these elements will be manufactured in such quantities as to make it possible to perform preregistration tests. System verification and validation will also be performed, as the necessary elements of the registration and certification process. Eventually, the team will undertake actions to finalize the registration and certification of the PCR|ONE system, and these works shall continue until mid-2020.
In the case of the other system that is being developed at the same time, namely BacterOMIC, the Company estimates that thanks to the schedule update the works on this device may be completed even 18 months sooner than originally planned. Currently, the EU certification and registration of the BacterOMIC system is planned for mid-2021.
The most important change in our timeline is related to the acceleration of works on the BacterOMIC. project. We are now planning to undertake the registration and certification process of this device already in mid-2021, which is 1.5 year earlier than we initially assumed. Then, we can also start marketing the system, announces Prof. Piotr Garstecki.
The detailed action plan for the BacterOMIC project assumes that the system will be ready for the industrialization phase on Q4 2019. This stage involves chip design optimization and designing the F&S line for filling chips with of all the substances used in the first diagnostic panel planned, as well as conducting the second series of pre-validation tests. In Q1 2020 the Company plans to be ready for preregistration tests – this will also be the first stage of industrialization. Two or three analyzers will be made along with the injection molds for chip production. A pilot line will be launched, on which the sufficient quantity of chips with reagents will be produced for the third series of pre-validation tests in Q2 2020. In late 2020 the Company plans to launch the production line for chips and analyzers and conduct preregistration tests. The final stage of system certification and registration is planned for Q3/4 2021.
The performance of scheduled works for the BacterOMIC system will depend on additional funding. The development of the BacterOMIC system is to be financed from the EU grants and other external sources, including such arrangements that do not involve indebtedness.