Bosch and Randox Partner to Make Strategic Investment in Vivalytic Analysis Platform

Given the presence of so many diseases, determining whether a patient is presenting the symptoms of a simple cold, the flu, or something as severe as life-threatening meningitis is usually only possible with time-consuming and expensive laboratory diagnostics. Bosch (Gerlingen, Germany) aims to make fast and highly precise diagnostics accessible at the point of care with its Vivalytic analysis platform and become a leading market provider by 2030 through molecular diagnostics. To achieve this goal, Bosch has entered into a strategic partnership with Randox Laboratories Ltd. (Crumlin, UK). The two companies will invest about EURO 150 million in joint research, development, and sales activities for new tests for the Vivalytic analysis platform. A key goal of the partnership is to develop a sepsis IVD grade test that will be the first to feature the highly innovative and novel BioMEMS technology.

The universal Vivalytic molecular diagnostics platform was developed in over ten years by researchers at Bosch and brought to market maturity by Bosch Healthcare Solutions. The Bosch Vivalytic platform not only provides the advantage of carrying out rapid PCR tests but also offers ease of use. After the sample is taken, it is placed in the test cartridge which contains all the required reagents for the respective test, and then inserted into the Vivalytic analyzer for automatic analysis. Medical staff need little training on how to operate the Vivalytic analyzer which enables fast and targeted diagnostics right at the point of sample collection – either at a doctor’s office or a hospital – eliminating the long and time-consuming detour through a central laboratory.

Bosch is now aiming to become a leader in the point-of-care molecular diagnostics market which is expected to be worth billions in the future with its Vivalytic analysis platform. Bosch Healthcare Solutions and Randox have joined hands to speed up the development and market launch of new tests and to make distribution channels more efficient. Bosch Healthcare Solutions and Randox have collaborated earlier during the Covid-19 pandemic. In the spring of 2020, Bosch had launched one of the world’s first fully automated SARS-CoV-2 PCR test. Along with Randox, the rapid test designed for use in a doctor’s office, nursing home, testing station, and hospital was readied for the Vivalytic analysis device in only a few weeks.

The new partnership between the two companies is expected to continue for over ten years. With Vivalytic, they aim to achieve sales in the medium nine-figure range by 2030. The two partners are an excellent fit: Bosch can contribute its technology and manufacturing expertise in the fields of molecular diagnostics, microchip development and manufacturing, and miniaturization. Randox has 40 years of experience in designing and developing highly sensitive IVD tests performed using various technologies, including microfluidic platforms. Combined with the company’s in-depth market knowledge and global sales and distribution network, this offers significant growth opportunities.

A key focus of the partnership will be the implementation of a highly sensitive multiplex test for sepsis on the Vivalytic analysis platform. Sepsis is a potentially life-threatening complication that can occur along with various infectious diseases. Sepsis is a medical emergency that can cause organ failure and requires urgent medical treatment. For the first time, the planned IVD grade sepsis test will be based on the highly innovative and novel BioMEMS technology developed by Bosch. BioMEMS combines microelectromechanical systems (MEMS) with microfluidics for applications in medical technology. The powerful BioMEMS chip contributes further to the innovative Vivalytic test cartridge by allowing it to test simultaneously and much faster for a wider variety of pathogens.

Microfluidics involves moving tiny amounts of fluid in the microliter range within an extremely small space. Miniaturization enables qualitative biochemical polymerase chain reactions (PCR) to run simultaneously in real-time on a single BioMEMS chip. The new BioMEMS technology makes it possible to perform fully automatic testing of up to 250 genetic characteristics (e.g. pathogens) in one cartridge in under 15 minutes. The test cartridge is a highly complex laboratory and the size of a smartphone. Another advantage to be offered by BioMEMS is the simpler and quicker adaptation of new tests or existing tests on the chip itself. For instance, the current tests can be easily expanded to integrate additional features.

The BioMEMS technology paves the way for Bosch to enter the nanofluidics space, where every pathogen is examined in a reaction vessel equivalent to the thickness of a hair. To achieve this, Bosch aims to add more capacity to a MEMS chip and expand what are known as “nanocavities”. These very small cavities will allow even more biochemical processes to run in parallel on a chip. The increasing miniaturization offers potential for the technology to be used in oncology as well over the long term.

Bosch Healthcare Solutions currently distributes various tests for diseases of the upper and lower respiratory tract, such as SARS-CoV-2 – also as a pooling variant and as a saliva test – or a test that distinguishes between SARS-CoV-2, RSV virus, and influenza. It also offers tests for pathogens causing sexually transmitted infections (STI) and MRSA / SA (“hospital germ”). From the summer of 2024, Bosch Healthcare Solutions plans to expand its portfolio by offering tests for whooping cough (Bordetella holmesii, Bordetella parapertussis, and Bordetella bronchiseptica), urinary tract infections (UTI), bacterial meningitis, two most common sexually transmitted diseases (Chlamydia trachomatis; CT and Neisseria gonorrhoeae; NG), fungal infections (Candida auris), and three tests for diarrheal diseases (norovirus, Clostridioides difficile, HSP).

“Globally, healthcare is moving toward decentralized and personalized diagnostics, that enable rapid interventions and individual treatment plans,” said Marc Meier, managing director of Bosch Healthcare Solutions GmbH. “With our partner Randox, we want to further expand the test portfolio of our Vivalytic analysis device. Our fully automated molecular-diagnostic PCR tests provide clarity directly at the site of sample collection, shorten waiting times, and take the strain off the healthcare system.”

“Randox has always been committed to improving health worldwide and sees the need to invest in research and development initiatives that will support clinical decision making across a variety of disease areas,” added Dr. Peter Fitzgerald, Managing Director of Randox Laboratories Ltd. “Diagnostics has always been an indispensable component of healthcare, and the alignment of both science and technology makes for the perfect fit in an area for high potential impact, especially in pressure-driven environments.”

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