PRESS RELEASE: Spindiag declares CE-conformity for two new Rhonda PCR rapid tests for use at the Point of Care (POC)

Spindiag GmbH, an in-vitro diagnostics Start-up based in Freiburg/Breisgau, Germany, today announced that it has declared CE-IVD conformity for two new tests for its Rhonda PCR rapid testing system. The new Rhonda Respi disk allows the detection of SARS-CoV-2, Influenza A, Influenza B, and the Respiratory Syncytial Virus (RSV) with only one swab sample in well under one hour. A test to detect Methicillin-resistant Staphylococcus aureus (MRSA) was also CE-marked and complements the growing portfolio of the company, which currently commercializes its Rhonda system in Germany and Austria.

Dr. Daniel Mark, CEO and co-founder of Spindiag, said: “Point-of-care testing is becoming increasingly important for infection diagnostics. There is a high medical need for rapid, reliable tests that can be used in hospital emergency rooms to prevent the spread of infectious diseases caused by pathogens that are detected too late. I am very pleased that our Start-up once again demonstrated its innovative strength by launching two new PCR-tests at the same time. With the Respi test, healthcare professionals can now simultaneously detect four viral respiratory pathogens in less than one hour. For example, the SARS-Coronavirus-2 can be differentiated from an Influenza virus and targeted infection control measures can be taken immediately. While COVID-19 has put the focus on viral pathogens, we must not forget that antibiotic-resistant bacteria are a serious challenge for healthcare systems worldwide, as a recent Lancet study showed1. To address this challenge, we have developed our second new test: the Rhonda MRSA test reliably detects the resistant pathogen, and thereby protects vulnerable groups. Rapid and reliable detection can help slow down the spread of antibiotic-resistant bacteria in healthcare systems.“

Although most COVID-19 protection measures were lifted, testing still remains very important in healthcare facilities. Since face masks are not mandatory in public spaces any longer, respiratory pathogens can again spread more easily. Viral respiratory diseases have very similar symptoms and therefore require rapid decision-making at the point of care. The Rhonda Respi test allows this medical need to be met. COVID-19 has also exacerbated the situation for spreading of antibiotic-resistant pathogens, as bacterial co-infections can occur while having COVID-192. Rhonda enables hospital staff to take the right decisions simply and rapidly: the testing system combines speed with the reliability of PCR-testing. Pre-emptive isolation measures can thus be avoided, and vulnerable groups can be effectively protected from possible infections at the same time.