• Spindiag declares CE-IVD conformity for two new tests for use on its Rhonda PCR-rapid testing system
  • Rhonda Respi disk for detection of SARS-CoV-2, Influenza A/B and RSV and a new MRSA test for detection of antibiotic-resistant bacteria
  • Expansion of test portfolio demonstrates innovative strength of Freiburg-based Start-up

Freiburg/Breisgau, Germany, May 31, 2022 – 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.

Learn more about Rhonda and meet us at the 53rd Joint Annual Meeting of the Austrian Society of Internal and General Intensive Care and Emergency Medicine (Österreichische Gesellschaft für Internistische und Allgemeine Intensivmedizin und Notfallmedizin, ÖGIAIN) & the German Society of Internal Intensive Care and Emergency Medicine (Deutsche Gesellschaft für Internistische Intensivmedizin und Notfallmedizin, DGIIN), June 22-25, 2022, in Salzburg, Austria.

1Global burden of bacterial antimicrobial resistance in 2019: a systemic analysis, The Lancet, Volume 399, Issue 10325, P629-655, February 12, 2022

2Covid-19 may have led to a spike in antibiotic resistance, Medical News Today, May 2, 22

About Rhonda

The fully automated Rhonda PCR rapid testing system consists of an analyzer, the so called Rhonda player, with an insertable test cartridge, the so-called Rhonda disk. Rhonda technology provides reliable, laboratory-quality PCR test results in well under one hour, making it easy to integrate the system into everyday clinical practice – at the point of care. The test procedure is simple and highly user-friendly: swab samples can be placed directly into the test cartridge without manual pipetting – it contains all the reagents required for testing. This saves time and reduces the potential risk of infection for users to a minimum. Similar to a CD, the Rhonda disk is inserted into the Rhonda player and processed fully automated. Another advantage is that two Rhonda disks of the same application can be processed simultaneously in the analyzer, enabling efficient testing. The results can be read directly on the Rhonda player and – if needed – transferred digitally to the Rhonda app or to the hospital IT.

About Spindiag GmbH

Spindiag GmbH is an in-vitro diagnostics Start-up based in Freiburg/Breisgau, Germany. The company was founded in 2016 by a team of internationally renowned experts in the fields of microfluidics, lab-on-a-chip technology, and life sciences as a spin-off from Hahn-Schickard and the University of Freiburg. Spindiag aims to provide rapid diagnostic results in a simple manner: its PCR-based rapid testing system Rhonda offers healthcare professionals in hospitals and other healthcare facilities a sustainable platform for reliable infection control at the point of care. With a multidisciplinary team of more than 100 employees at three local sites, Spindiag develops and commercializes its testing system based on proprietary microfluidic technology.

The current test portfolio includes three rapid PCR-tests: for the detection of SARS-CoV-2 (CE-mark 2020), for the differentiated detection of SARS-CoV-2, Influenza A, Influenza B and the Respiratory Syncytial Virus (RSV), plus a test to detect Methicillin-resistant Staphylococcus aureus (MRSA). In the future, the modular Rhonda platform will be able to detect up to 36 pathogens in less than one hour.

Spindiag has already received numerous awards, including from healthcare experts such as B.Braun in the CODE_n competition and Techniker Krankenkasse together with Handelsblatt in the health-i competition. In 2021, the Rhonda testing system received the internationally renowned Red Dot Design Award for its outstandingly simple and user-friendly design. The company is certified according to EN ISO 13485. www.spindiag.com

Rhonda is a registered trademark of Spindiag GmbH.

Contact for inquiries:

Simone A. Schümmelfeder
Head of Marketing and Communication
E-Mail: publicrelations@spindiag.com
Tel.: +49 (0) 761 600 49 660

Bildmaterial für die Presse

Rhonda PCR rapid testing system with two new Rhonda tests, Source: Spindiag

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Dr. Daniel Mark, CEO und Co-Founder Spindiag GmbH

Dr. Daniel Mark, CEO and Co-Founder Spindiag GmbH, Source: Spindiag

High resolution images