NEW YORK – Bosch Healthcare Solutions and Randox Laboratories of Northern Ireland have built on an existing molecular diagnostics partnership to develop a fully-automated coronavirus test for Bosch's point-of-care Vivalytic system that will soon be available for patient testing in Europe and beyond.
"Together with our partner Randox, we have succeeded in developing this innovative rapid test within a very short time frame, and we are now in a position to offer it to the market," said Marc Meier, president of Bosch Healthcare Solutions, a subsidiary of the Bosch Group, in a statement.
The new COVID-19 test, which was developed within six weeks, is part of a viral respiratory tract infection (VRI) panel that also tests for nine other viruses that cause similar symptoms, including influenza A and B and all known coronaviruses. It has a turnaround time of 2.5 hours, starting from the arrival of a sample, and each Vivalytic device can complete up to 10 tests in 24 hours.
Bosch unveiled the Vivalytic, which uses cartridges and automates all sample prep steps, two years ago at the European Congress of Clinical Microbiology and Infectious Diseases. The platform can perform four types of assays: endpoint PCR, quantitative real-time PCR, melt curve analysis, and microarray detection. At the time, Bosch said it had partnered with Randox and German diagnostics firm R-Biopharm to develop a test menu for the system, starting with a 22-plex respiratory pathogen panel from Randox.
Since then, the Vivalytic system has garnered the CE mark and has become commercially available in the European Union, where Bosch is selling it through distribution partners such as Randox, Aprimeo Diagnostics, and Arrow Diagnostics, said Martin Schulz, head of laboratory diagnostics at Bosch Healthcare Solutions, in an email.
On its website, Aprimeo Diagnostics offers two panels for the Vivalytic system, a sexually transmitted infection (STI) panel that includes 10 pathogens and a respiratory tract infection (RTI) panel that includes 22 bacterial and viral pathogens. It also lists a number of tests that are in development, including a urinary tract infection (UTI) panel, a flu & RSV panel, a chronic lung disease panel, a Pneumocystis test, a Bordetella test, a hospital stool panel, an MRSA test, a Clostridium difficile test, and a norovirus test.
While Schulz did not disclose the number of Vivalytic systems installed to date, he said that instruments are in service across Europe, primarily in laboratories, clinics, and medical institutions but also in physician offices.
At the moment, the Vivalytic VRI panel is available for research use only, Schulz said, but the firms are "working with local authorities to obtain special approvals based on country-specific requirements." The goal is to obtain the CE mark in April, after which the panel will become available in Germany and other EU countries, followed by non-EU regions.
Robert Bosch Hospital in Stuttgart, Germany, which already has Vivalytic devices installed, is supporting validation of the VRI panel, he said, and other existing Vivalytic installations will "allow us to gather additional data and obtain feedback on the system."
Once available for patient testing, the Vivalytic VRI test will likely compete with other decentralized or point-of-care systems that have coronavirus tests available, for example platforms from Abbott, Cepheid, and Mesa Biotech.
It might also compete with Qiagen's QiaStat-Dx Respiratory SARS-CoV-2 panel, which includes more than 20 viral and bacterial pathogens and runs on the QiaStat-Dx platform. In addition, BioMérieux, which already has a COVID-19 test, has said it is working on expanding its BioFire FilmArray Respiratory Panel 2 (RP2), which detects 21 pathogens, to include SARS-CoV-2. The expanded panel, to be called BioFire Respiratory 2.1, will run on the firm's BioFire 2.0 and BioFire Torch systems.
Schulz declined to comment on potential competitors but pointed out that the Vivalytic is a universal platform that is easy to operate and "requires minimal training," yet allows to test for a panel of pathogens.