News from the BioCity Campus

SelfDiagnostics intends to apply for approval for a rapid at-home PCR-COVID19 test

The Europe-based company Selfdiagnostics (GER, EST) plans to submit an application for approval of its molecular diagnostic test for use at home and at the point of care - to detect the coronavirus SARS - CoV-2. Selfdiagnostics' Rapid PCR Test is the first multifunctional test that allows simultaneous detection of COVID and influenza from a non-invasive nasal swab.
“Selfdiagnostics' device-free multitest is based on nucleic acid amplification and has significantly fewer false negative results than the serological test. The test is fully comparable in sensitivity and specificity to the FDA-approved home molecular diagnostic test on November 20, as demonstrated by review of clinical reference samples from COVID 19 patients,” said Selfdiagnostics PhD Scientific Advisory Board member, Prof. Tamas Bartfai.

Marko Lehes, CEO and co-founder of Selfdiagnostics, said that home use PCR is a revolutionary approach to bringing lab-grade accuracy into the hands of end users. “Selfdiagnostics has proven its technology in STDs and is now, following a successful interim clinical study, launching COVID and influenza multitest in the current viral season and ramping up production in Europe,” said Lehes.

Selfdiagnotics Rapid PCR Multitest is based on isothermal PCR, which is already FDA-approved for home use, paving the way for a huge increase in test cases, which is still an important step to stop the pandemics.

Selfdiagnostics COVID Multitest is confirmatory due to ongoing PCR, which cannot be said with antigen tests. The test is faster than laboratory PCR - the time from sample collection to result is only 40 minutes and the test is non-invasive - runs on an easily collected nasal swab and/or saliva. People who have symptoms or who have been in contact with a positive patient can be tested anywhere, anytime outside of the laboratory - at home, at work, in doctor's offices, pharmacies, etc.

Information on Selfdiagnostics

Selfdiagnostics Deutschland GmbH brings laboratory medical precision tests in laboratory quality for home use and offers the world's smallest application of PCR (polymerase chain reaction) technology ( This unique product paves the way for major changes in medicine as patients take the first steps toward diagnosing disease. In this way, Selfdiagnostics has developed a unique molecular diagnostics platform for point-of-care medical devices. Selfdiagnostics' proprietary technology enables various DNA and RNA detection methods for respiratory diseases (Covid, Influenza, TB), blood-borne diseases (HIV, Hepatitis) and urine (CT, NG, MG, TV, Zika).

Source: press release Selfdiagnostics in press portal from December 02.12.2020nd, XNUMX

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