Spindiag brings Covid-19 rapid tests to market

EIT Health Catapult Finalist successfully completed CE-IVD certification of its PCR rapid SARS-CoV-2 test.

In March 2020, Spindiag was one of the first health start-ups that adapted their health solutions in response to the Covid-19 pandemic. The result was a point-of-care testing system to detect bacterial and viral pathogens – Rhonda diagnostic platform for the detection of the SARS-CoV-2 virus.

The Rhonda “mini-lab” was designed with decentralized settings in mind to enable simple and reliable testing at the point of care. It applies a two-step polymerase chain reaction (PCR) test, which represents an advantageous variation of the laboratory gold standard PCR test and will be able to provide test results about a coronavirus infection in approximately 30 to 40 minutes.

In May 2020, Spindiag successfully closed a Series B financing round of €16.3 million, intended for the market launch of the Rhonda diagnostic platform. Five months later, the company announced that it has successfully completed the market entry assessment of its PCR rapid SARS-CoV-2 test. Spindiag’s Rhonda will now be rolled out in phases in Germany, the EU, and other countries that accept the CE mark for in vitro diagnostics (CE-IVD).

PCR-based testing methods are considered the gold standard in infection diagnostics. They play a key role in Germany’s current national testing strategy, because they can detect the genetic information of SARS-CoV-2 and thus the virus itself directly and sensitively, thereby enabling accurate clinical decision making.

One of the first testing devices will be installed at Klinikum Stuttgart, one of the largest and highest-performing hospitals in Germany. As a dedicated COVID-19 care center of the metropolitan region, the Klinikum Stuttgart, where more than 100,000 tests on SARS-CoV-2 have already been conducted, plays an important role in managing the pandemic through diagnostics and patient care.

Speed is often vital. More than 100,000 patients are admitted to Klinikum Stuttgart as emergency cases every year. Rapid diagnostics help medical professionals make the right decisions in acute situations. The new PCR rapid coronavirus test developed by Spindiag will be used from now on in the hospital’s emergency departments and combines the best of both worlds: the reliability of PCR-based testing and speed,” states Prof. Dr. Jan Steffen Juergensen, Medical Director and Chairman of the Management Board of Klinikum Stuttgart.

The long-term goal of the Freiburg startup is to develop a comprehensive and sustainable testing system for infection control. With its first product, the Rhonda PCR rapid SARS-CoV-2 test, the company has brought a key technology to market that will provide diagnostic support for differentiated hygiene decisions by enabling numerous bacteria and viruses to be detected in a single analysis in the future – all in less than an hour.

Read the official press release here.