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Prototyping 'intime' - a NINAAT-based self testing platform to detect infectious diseases

Periodic Reporting for period 5 - intime (Prototyping 'intime' - a NINAAT-based self testing platform to detect infectious diseases)

Reporting period: 2017-04-01 to 2017-09-30

SelfDiagnostics will introduce a game changing product to the market by utilizing the power of a non-instrumented nucleic acid amplification test (NINAAT) method. The ‘intime’ project will enable us to provide a test device that can detect up to three pathogens simultaneously. Our test will require no previous training and uses only urine as an input medium. Therefore, neither a laboratory nor an instrument is required for its performance. The Selfdiagnostics test device will be widely available at an affordable price in pharmacies, online and general practices. Simply take a small body fluid sample and receive a fast answer about the presence or absence of a specific infection. The test is discreet and can be completed in a comfortable and non-invasive environment.
The technological invention of SelfDiagnostics is the combination of a robust sample lysis/pretreatment, isothermal amplification and simple lateral flow visualization into one product applicable by lay persons.
During Oct 2016-March 2017 the “intime” team has made several high importance decisions and has completed the tasks related to prototype (M2) and freedom to operate (FTO) analysis (D5.2).
SelfDiagnostics followed and fulfilled the project plan and submitted next to D5.2 the deliverable D3.1 “Report on pathogen cultivation and establishment of handling procedures for the validation” in time. The report lists the prepared standard operating procedures, annexes and test plans describing the procedures that will be used during analytical performance evaluation and stability testing.
The report about the FTO (freedom-to-operate) analysis clarifies that based on the intensive research conducted no risks related to patent rights were identified. Thus, the analyses assured freedom to operate at the status. Nevertheless, Selfdiagnostics is continuously monitoring the IP situation. Furthermore, Selfdiagnostics continuous with drafting patent applications, clarifying its inventions and crystallizing the major claims. The patenting strategy is fixed. Thus, if it is required Selfdiagnostics is prepared to adopt appropriate measures to protect our IP rights.

In addition, the prototypes of module A, B and C including the blisters to release the blister-buffer and air by an easy push-down was successfully tested by the end of Nov. 2016 (finalized Milestone M2 “Completed prototype”). A credit-card shaped design of the corechip was agreed without changing any functionalities compared to the long-shape design of reporting phase 3. The engineering phase of the corechip prototype was completed and the producible CAD-drawings are ready. Based on the frozen corechip prototype the housing design was adapted and finalized. The engineering phase of the housing, resulting in adapted CAD-drawings ensuring the producibility of the design started and will be completed within May for the final injection molding.
Since the prototype functionality testing is completed and the design of the product housing is frozen, SelfDiagnostics has mapped the detailed test handling procedure of the product, starting from the description of the package content, sample collection and ending with read-out of the test result. This simple and efficient procedure ensures the testing at the point of care.

SelfDiagnostics and its partners have started tasks related to the small-series production set-up. Required instrument and room specifications were set, offers were received and instrument lead times are planned. The facility for the production room and storage room is set and furnished. Selfdiagnostics is identifying and mapping the risks which could appear during manufacturing processes, the risk analyses will be completed in near future plus other additional tasks (such as equipment installation for manufacturing) has to be done before going into small-series production.

In Q7 and Q8 SelfDiagnostics has continued to work on the establishment of a Quality Management System (QMS) in compliance with ISO 13485 and ISO 14971 (work package 4). In addition to previously established processes, the ‘intime’ team has started to implement a series of new processes and documents e.g equipment list; list of applied standards; list of applicable normative and legal regulations etc. Also documents related to design transfer (completed) and as already mentioned Selfdiagnostics has started to prepare small-series manufacturing processes like production and maintenance processes, SOP for production, qualification and validation processes, quality assurance agreements with production partners. The implementation of the QMS has a risk reducing manner and by the end of the day most importantly assures the patient safety.

In parallel to other actions and tasks described above, SelfDiagnostics has introduced the project and the company to a wider audience by presenting it on stage to investors, investor panels, professional users and the key-players in the industry. The main
As one of Europe‘s most ambitious healthcare ventures SelfDiagnostics holds with the “intime” project a unique opportunity to provide an easy, accurate and safe detection of infections at home and at the point of care (POC).

Our POC-NINAAT diagnostic platform provides a disruptive technology challenging current test methods in healthcare systems as well as in the fields in which robust detection of nucleic acids is an advantage. The “Intime” test detects two of the most common sexually transmitted pathogens – Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) from urine. The test can be used either at home or anywhere you feel comfortable, and most importantly with unprecedented convenience.
“Intime” will help to detect diseases at an early stage, thus contributing to a substantial reduction in healthcare spending and – equally important - to an improvement of living conditions across the planet.

According to the plans, SelfDiagnostics will accomplish soon the product based on its proprietary NINAAT technology analytically and clinically evaluated (in 2017/2018) to achieve CE mark. In 2021-2022, additional products will be included in the product range (additional STI pathogens will be added), proving the wide application range of the NINAAT technology.

Combining the best of laboratory technologies, low cost of a disposable device and strong exploitation and marketing strategy, Selfdiagnostics estimates to have annual sales up to 95,4 million EUR by 2022 and expects considerable raise to company’s value.