March 19th, 2021,Bergen – Lifecare’s partner, Digital Diagnostics AG (Digid), has developed a novel 5-minute antigen rapid virus detection test. The Cantisense test method is based on proteins binding onto the virus antigen, which leads to electronically measurable changes. The method is highly sophisticated and advanced compared to already existing virus detection test methods:
– The monoclonal antibody technology used enables highly specific and high affinity binding, enabling potentially high sensitivity and reliability of the test.
– Further development of the technology provides a platform-character for detection of various bio- and disease markers with short lead-time for upcoming regulatory approvals and market entry.
Cantisense development status
In Q4 2020 Digid intensified its efforts and has conducted further important testing of the Cantisense SARS-CoV-2-Test.
The remaining product development depends on frequent and repeated accesses to S3 high security laboratories to resemble data generation under real world conditions by measuring on the active SARS-CoV-2 virus. There are few S3 laboratories in Europe with access to living cultivated Covid-19 viruses. These S3 labs are currently overwhelmed with requests from development partners. With reduced access to S3 labs, Digid’s testing and analysis is currently delayed. This postpones the final process to prepare for ISO 13485 certification, a quality system enabling the company to market certified (CE mark) medical devices in the European Union and associated countries, and commercialization.
“The overall development at Digid is good and we are happy with the test results so far. The S3 labs with cultivated Covid-19 viruses are naturally overwhelmed with requests, which is delaying Digid’s testing and analysis. We are confident that Digid’s new type of virus detection will be brought to the market, although the timeline for bringing Cantisense SARS-CoV-2-Test to market has turned out longer than previously indicated,” says Joacim Holter, CEO of Lifecare, Digid’s partner.
While waiting on access to the labs, Digid is further optimizing the technology to ensure a solid platform for various detection tests with a short lead-time for up coming regulatory approvals and market entry. In the process of bringing the new test from the lab to the market, Digid has solved major logistical challenges related to production. The technology is expected to be applied for other diagnostic tests as well and this will be further explored.
For more information, please contact:
Joacim Holter, CEO
Phone: +4740 05 90 40
Lifecare(LIFE-ME) is a Bergen-based technology company developing a miniature sensor for correct and continuous monitoring of diabetics’ blood sugar. Its patented technology is also used as a central component in a rapid test for Covid-19 and as a measurement unit for reading out different biomarkers.