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

Periodic Reporting for period 7 - intime (Prototyping 'intime' - a NINAAT-based self testing platform to detect infectious diseases)

Reporting period: 2018-12-01 to 2019-03-31

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 Q11 until Q15 (October 2017 to December 2018) SelfDiagnostics and its partners reached essential goals to finalize the H2020 project successfully.

After solving technical issues within the first batch, new batches for the performance evaluation were successfully produced and released following the required quality standards. Following the master validation plan all qualifications and validations were successfully performed. Using the manufactured devices, the analytical performance evaluation was completed successfully fulfilling milestone 4. In parallel the QM-system was completed and is ready for ISO 13483 certification (fulfilled milestone 6). The deliverable 4.1 was submitted on time reporting on the established QM-system of SelfDiagnostics Deutschland GmbH. The deliverable 5.1 was completed and submitted in time, documenting the defined patent strategy and listing the patent applications that have been filed. By filing the patent applications milestone 8 was successfully reached.

To launch the delayed clinical study for the STD Multitest CT/NG an application to Ethical Committee was submitted and the approval to conduct the clinical study was received. In a pre-phase study 61 CT-positive-patients were analyzed on assay-basis ensuring a successful start for the Multitest device-based clinical study and assessing subgrouping criteria. First patients have been successfully included already in the Multitest device-based clinical study. This clinical study is ongoing.
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 2017-2019) to achieve CE mark. In 2020-2022, 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 2023 and expects considerable raise to company’s value.