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Bioelectronic lab-on-a-chip for point-of-care detection of infectious agents

Periodic Reporting for period 2 - AptaCheck (Bioelectronic lab-on-a-chip for point-of-care detection of infectious agents)

Reporting period: 2018-08-01 to 2019-07-31

One of the main challenges in healthcare all over the word is to get reliable and fast diagnostic tools for infectious diseases to initiate fast treatment of the patients and to prevent the spreading of the infections.
The problem today is that most of the rapid detection systems are too complex to handle for other personnel than laboratory assistant or doctors.

Furthermore, the antibiotic resistance is also among the biggest threats to global health, food security, and development today, and is one of WHO highest priorities:

• Antibiotic resistance can affect anyone, of any age, in any country.
• Antibiotic resistance occurs naturally, but misuse of antibiotics in humans and animals is accelerating the process.
• A growing number of infections are becoming harder to treat as the antibiotics used to treat them become less effective.
• Antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality.

To prevent and control the spread of antibiotic resistance, WHO says that the health industry can:
“Invest in research and development of new antibiotics, vaccines, diagnostics and other tools”.

AptaSystem platform from Solsten Diagnostics A/S could be one of the diagnostic tools which can support the fast and reliable diagnosis and the control of the use of antibiotics.

The overall goal of the AptaCheck project is to optimize, test and commercialize our point-of-care (POC) platform AptaSystem® to detect infectious diseases. AptaSystem® is a patented platform technology providing with an easy, accurate and quick diagnosis of infectious diseases from any body fluids. A technology, which can be used by non-specialists in any environment. With AptaSystem® the user can get diagnostic results with laboratory quality in Point of Care/Point of Need settings for decision making.
AptaSystem is based on an electrical measurement on a lab-on-a-chip system (AptaChip®) which is inserted into the high precision reader device (AptaViewer®). Both the AptaChip and the AptaViewer are developed at Solsten Diagnostics A/S, and the AptaChips are produced with our in-house semi-automated, industrial pilot production line.
The AptaChip® manufacturing processes have been optimized to ensure scalability of the production. In the AptaCheck project we are in progress to optimize the functionalization processes, to ensure the targeted specificity and sensitivity.

Furthermore, we have developed the first version of the chip reader AptaViewer® with a user-friendly design and user interface. The AptaViewer® is designed to be installed at clinics or at microbiological laboratories and can communicate with the data management systems in the lab by Wi-Fi. During the next phase of the AptaCheck project we are going to manufacture the improved version of AptaViewer® for the external performance evaluation and for CE approval.

Homepage, presentations, etc. have also been developed to disseminate our product to downstream partners, who could be our distributors in the future.

We have participated at MEDICA exhibition, on ECCMID (European Congress of Clinical Microbiology & Infectious Diseases) and other arrangements, where we could meet our future partners.
There is a strong demand for a reliable and inexpensive system to screen for pathogens. A system which makes it possible to screen a substantial number of patients is of high clinical interest.
With the AptaSystem platform technology we expect to bring a strong diagnostic tool to the marked, which has a turnover-time less than 10 minutes including sample handling with an accuracy comparable to the generally used PCR-based methods. This POCT tool can be used without any special equipment or skills. For the patients it means that they can adequately be treated, and infectious patients can immediately be isolated preventing eventual outbreaks.
The future AptaChips
The AptaSystem