27-May-2020 - SpinDiag GmbH

Start-up Raises 16.3 million Euros to Prepare Market Launch of its SARS-CoV-2 Rapid Testing System

“Mini-laboratory” provides test results in 30 to 40 minutes

Spindiag GmbH, a medical technology start-up company founded four years ago as a spin-off of the Hahn-Schickard Institute for Microanalytical Systems, announced the completion of a 16.3 million Euros (USD 17.8 million) Series B financing round as expected. Existing investors as well as Think.Health Ventures, a new investor from the healthcare sector, have participated in the Series B, the company’s fourth financing round. The capital increase will enable the market launch of the 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 corona virus infection in approximately 30 to 40 minutes.

The system is currently undergoing analytical testing. Spindiag expects to receive market approval in Germany and the EU during the third quarter 2020.

Dr. Daniel Mark, CEO and co-founder of Spindiag GmbH, said: “The completion of the Series B financing round represents a major milestone on the way to launching our coronavirus rapid test and for the further advancement of our testing platform for infectious diseases at the point of care. A test for multidrug-resistant bacteria (MRSA) will also be approved later this year in Germany and the EU and the market launch of further tests in 2021 is being prepared. We thank our existing investors and welcome our new investor Think.Health Ventures. Their participation will significantly strengthen our company’s health care expertise. All shareholders have great confidence in our platform’s potential, especially in these times of the coronavirus pandemic.”

Manfred Hoffmann, shareholder in WBG Nursing Homes and a Spindiag investor since 2019, added: “Decentralized testing systems for the reliable detection of SARS-CoV-2 could play an important role particularly in the implementation of a gradual relaxation in coronavirus quarantine policies. The Rhonda testing system was designed for mobile use at the point of care. It could potentially also be used for SARS-CoV-2 testing outside of hospitals, for example in nursing homes, at border controls, airports or in companies, where test results are needed quickly.”

Think.Health Ventures partner and founder, Dr. Florian Kainzinger, said: “With its innovative testing platform for infectious diseases, Spindiag fits perfectly into our portfolio. We were impressed by the start-up’s rapid and dynamic reaction to the coronavirus crisis. Right from the beginning of the pandemic, Spindiag immediately expanded its testing system, which initially was designed to detect multidrug-resistant bacteria, for the detection of the SARS-CoV-2 virus. We anticipate that even beyond the coronavirus crisis, testing will remain an important topic in healthcare, and may become a part of everyday life.”

The new financing round follows a previous 6 million Euro (USD 6.5 million) funding, announced in April 2020, which Spindiag and the Hahn-Schickard Institute for Microanalytical Systems jointly received from the Ministry for Economic Affairs, Labour and Housing of the State of Baden-Württemberg. The funding will enable the company to establish its SARS-CoV-2 rapid test on its existing platform and to scale up production of test cartridges to prepare for market launch.

The Rhonda testing system

The fully automated Rhonda testing system consists of an analyzer and a test cartridge. The proprietary technology allows for easy integration of the system at the point of care, as manual pipetting of swab samples into the test cartridge is no longer required. As a result, the risk of infection for users can be reduced to a minimum. The test procedure is very simple: swab samples from the nose and throat are inserted directly into the test cartridge, which contains all the reagents required for the test. Like a CD, the cartridge is inserted into the device and processed automatically. Another advantage: the device can analyze two cartridges simultaneously for a higher testing throughput. Test results are available in 30 to 40 minutes. They can be read directly from the device and – if necessary – transferred electronically. Since the cost of a test will be well below 50 Euros (USD 55), the system represents not only a simple and reliable, but also a cost-effective solution for the rapid detection of viruses and bacteria.

Two-step PCR testing procedure

The two-step PCR test method is an advantageous variation of the laboratory gold standard polymerase chain reaction (PCR). PCR tests can directly detect the genetic information of viruses from nasal / throat swab samples. By applying the two-step PCR approach, the test cartridge performs two standard PCRs in a row, producing sensitive and specific, thus reliable analyses.

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