- The Economic Committee of Baden-Wuerttemberg’s Ministry for Economic Affairs, Labour and Housing Construction approved of funding in fast track authorisation
- Nested PCR test for results in about 35 minutes directly at the point of care
Freiburg im Breisgau, April 7, 2020 – Spindiag GmbH, based in Freiburg im Breisgau, is a medical technology start-up that arose out of the renowned Hahn-Schickard Institute for Microanalytical Systems four years ago. Together with Hahn-Schickard, the company announced today that it will receive a total of six million euros in funding from the State of Baden-Württemberg for the development of a SARS-CoV-2 rapid test. This so-called nested PCR test can be used directly at the point of care, meaning at the place where samples are taken, thereby reducing time to diagnosis. The Economic Committee of the Ministry of Economics, Labour and Housing Construction approved the funding in a fast track authorisation on April 7th. It will enable the company to establish a rapid test for the SARS-CoV-2 virus on its existing test platform, which was developed for the detection of multidrug-resistant bacteria. The test will enable the reliable detection of SARS-CoV-2 in about 35 minutes. It is also planned to expand the platform for differential diagnosis of other respiratory diseases including seasonal influenza. The test system is currently undergoing analytical testing. The aim is to launch with a CE-IVD declaration of conformity by the third quarter of 2020.
Dr. Daniel Mark, CEO of Spindiag GmbH, states: “The corona pandemic is currently posing major challenges for the German health care system and health care systems worldwide. We can assume that there will continue to be a high demand for SARS-CoV-2 test systems, especially at the point of sample taking so that doctors can immediately order quarantine and initate further measures if necessary. We are very pleased that we were able to convince the state of Baden-Wuerttemberg of the potential and sustainability of our platform.”
The Spindiag platform consists of an analyzer with an integrated test cartridge that can be intuitively integrated into the clinical routine. Without any preparation, swab samples from the nose or throat can be inserted directly into the test cartridge, which contains all the reagents required for the test. Similar to a CD, the cartridge is then inserted into the device and processed fully automatically. Results are available in about 35 minutes. A further advantage: two cartridges can be processed simultaneously in the device, which enables higher test capacities. Thanks to proprietary technology, manual pipetting of the sample into the test cartridge is no longer necessary. The risk of infection for users can thus be reduced to a minimum.
Test results can be read directly from the device and, and if necessary, the data can be transmitted anonymously via the mobile network or a direct cloud connection to relevant institutions.
About the nested PCR test method
The nested PCR test method is a further development of the common standard laboratory analysis called polymerase chain reaction (PCR), with which the virus can be directly detected in a sample. In the nested PCR approach, two stages of the standard PCR are connected in series in the test cartridge. This enables particularly sensitive, specific and therefore reliable analyses.
Spindiag GmbH, based in Freiburg im Breisgau, Germany, was founded in 2016 by a team of internationally renowned experts in the fields of microfluidics, lab-on-a-chip technology and life sciences. Based on a proprietary microfluidic technology researched at the Hahn-Schickard Institute for Microanalytical Systems, Spindiag is developing a sustainable platform for the diagnosis of infectious diseases and plans to offer a rapid test for the SARS-CoV-2 at the point of care as first product. Since its foundation, the company has received a total of 8.6 million euros in three financing rounds to prepare for market entry.
Dr. Daniel Mark, CEO
+49 761 203 73246