March 19th, 2021, Bergen - Lifecare's partner, Digital Diagnostics AG (Digid),has developed a novel 5-minute antigen rapid virus detection test. TheCantisense test method is based on proteins binding onto the virus antigen,which leads to electronically measurable changes. The method is highlysophisticated and advanced compared to already existing virus detection testmethods:
- The monoclonal antibody technology used enables highly specific and highaffinity binding, enabling high sensitivity and reliability of the test. - Further development of the technology provides a platform-character fordetection of various bio- and disease markers with short lead-time for upcomingregulatory approvals and market entry.
Cantisense development statusIn Q4 2020 Digid intensified its efforts and has conducted further importanttesting of the Cantisense SARS-CoV-2-Test.
The remaining product development depends on frequent and repeated accesses toS3 high security laboratories to resemble data generation under real worldconditions by measuring on the active SARS-CoV-2 virus. There are few S3laboratories in Europe with access to living cultivated Covid-19 viruses. TheseS3 labs are currently overwhelmed with requests from development partners. Withreduced access to S3 labs, Digid's testing and analysis is currently delayed.This postpones the final process to prepare for ISO 13485 certification, aquality system enabling the company to market certified (CE mark) medicaldevices in the European Union and associated countries, and commercialization.
"The overall development at Digid is good and we are happy with the test resultsso far. The S3 labs with cultivated Covid-19 viruses are naturally overwhelmedwith requests, which is delaying Digid's testing and analysis. We are confidentthat Digid's new type of virus detection will be brought to the market, althoughthe timeline for bringing Cantisense SARS-CoV-2-Test to market has turned outlonger than previously indicated," says Joacim Holter, CEO of Lifecare, Digid'spartner.
While waiting on access to the labs, Digid is further optimizing the technologyto ensure a solid platform for various detection tests with a short lead-timefor upcoming regulatory approvals and market entry. In the process of bringingthe new test from the lab to the market, Digid has solved major logisticalchallenges related to production. The technology is expected to be applied forother diagnostic tests as well and this will be further explored.
For more information, please contact: Joacim Holter, CEOPhone: +47 40 05 90 40Email: email@example.com
Lifecare (LIFE-ME) is a Bergen-based technology company developing a miniaturesensor for correct and continuous monitoring of diabetics' blood sugar. Itspatented technology is also used as a central component in a rapid test forCovid-19 and as a measurement unit for reading out different biomarkers.