Bosch and Randox: Strategic partnership brings highly multiplexing PCR to the point of care / BioMEMS technology enables fully automated, simultaneous testing for hundreds of genetic characteristics in just a few minutes

• Bosch and Randox Laboratories Ltd. enter partnership for Vivalytic
  analysis platform to jointly invest around 150 million euros.
• First test to feature novel BioMEMS technology will be a highly
  multiplexing sepsis IVD grade test.

Wiblingen – Bosch has agreed on a strategic partnership with Randox Laboratories
Ltd., a leading diagnostic and medical technology company. The two
companies will invest around 150 million euros in joint research,
development, and sales activities for new tests for the Vivalytic
analysis platform provided by Bosch Healthcare. One goal is the
development of a sepsis IVD grade (in-vitro diagnostics) test that will
be the first to feature highly innovative and novel BioMEMS technology.

Trend toward decentralized, personalized diagnostics

Bosch wants to grow long-term in molecular diagnostics. To achieve this,
the company is contributing its technology and manufacturing expertise
across the fields of molecular diagnostics, microchip development and
manufacturing, and miniaturization. “Globally, healthcare is moving
toward decentralized and personalized diagnostics, that enable rapid
interventions and individual treatment plans,” says 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,” Meier adds.

One focus of the development partnership with Randox is the
implementation of a highly sensitive multiplex test for sepsis on the
Vivalytic analysis platform. This is a potentially life-threatening
complication that can occur in conjunction with various infectious
diseases. It can lead to multiple organ failure and requires immediate
medical treatment. “Clinical outcomes in sepsis depend on timely
diagnosis and appropriate early therapeutic intervention. Current
methods of sepsis diagnosis are insufficient and time-consuming. With
over 10 years of experience in the field of infectious diseases
diagnostics, we aim to develop a state-of-the-art sepsis test using a
highly multiplexing BioMEMS chip. Such a test could revolutionize sepsis
diagnosis, ultimately leading to improved treatment outcomes and lower
mortality rates from this life-threatening condition,” says Dr. Peter
Fitzgerald, Managing Director of Randox Laboratories Ltd. To this end,
the functions of a high-performance silicon chip based on microsystems
technology will be added to the test cartridges, combining the expertise
of the Bosh development teams in the areas of MEMS chips, molecular
diagnostics, and microfluidics.

More than 250 genetic characteristics in less than 15 minutes

The powerful BioMEMS chip adds a further innovative analysis method to
the Vivalytic test cartridge, enabling it to test simultaneously and
significantly faster for a large number of different genetic
characteristics, e.g. pathogens such as viruses, bacteria, fungi and
parasites, as well as their resistance to drugs, or to identify genetic
mutations in tumors. It is called BioMEMS because it combines
microelectromechanical systems (MEMS) with microfluidics for
applications in the field of medical technology. In microfluidics, very
small amounts of fluid in the microliter range are moved, processed, and
analyzed in a very small space. Miniaturization allows qualitative
biochemical polymerase chain reactions (PCR) to run in parallel in real
time on a single BioMEMS chip. The analysis of liquids is left to a
small microchip. The technology paves the way to move into nanofluidics,
i.e. miniaturization by a factor of 1,000, allowing even more
biochemical processes to run in parallel. “Our test cartridge is a
highly complex laboratory the size of a smartphone, so to speak,” Marc
Meier explains. This will enable fully automatic testing of up to 250
genetic characteristics in one cartridge and in some instances in less
than 15 minutes. Another future advantage of BioMEMS will be simpler and
faster adaptation of new tests or existing tests on the chip itself. For
example, new pathogens can be added to an existing test. With increasing
miniaturization, the technology has potential to be used in oncology as
well over the long term.

Contact persons for press inquiries:

Thomas Berroth

Marketing & Communication

[email protected]

+49 (0) 160 90437856