Microfluidic point of need (PoN) tests require just a fraction of a sample in order to analyze and interpret data. This approach has grabbed the attention of several semiconductor players that are now starting to show interest in the fields of life sciences, microfluidics, and diagnostics.
The semiconductor industry is well structured. Consequently, major companies (including the largest and most profitable semiconductor manufacturers) are diversifying their activities and launching new, in-development PoN tests. These companies are leveraging the manufacturing methods and in-house expertise they’ve acquired over decades of involvement in the semiconductor segment. Hence they’re seeking new ways to capture value and ensure product portfolio growth.
In Yole Développement’s (Yole) Point of Need Testing: Application of Microfluidic Technologies 2018 report, Yole’s analysts explain how the PoN supply chain is evolving and identify the potential market leaders of tomorrow.
As an illustration of this trend, Bosch, one of the leading MEMS players, recently announced the launch of its Vivalytic solution for point of care (PoC) molecular diagnostics. Benjamin Roussel, LifeScience and HealthDivision Director recently had the opportunity to interview Martin Schulz, Director of Laboratory Diagnostics at Bosch Healthcare Solutions. His input helped the Yole team to better understand the Vivalytic solution and Bosch’ strategy and vision regarding PoC testing. Below is a summary of their discussion.
Benjamin Roussel: Can you briefly introduce Bosch Healthcare Solutions, its history, activities, and healthcare products?
Martin Schulz: Bosch Healthcare Solutions GmbH (BHCS) is a wholly owned subsidiary of Robert Bosch GmbH. Bosch Group’s core competencies include sensors to collect data, software to evaluate data, and data analysis services. BHCS was established in 2015 with the aim of developing products and services that improve people’s health and quality of life.
In any product development endeavor, strong partners provide invaluable expertise. In this case, Bosch’s corporate sector for Research & Advanced Engineering provides the scientific basis for developing new products, while the Robert Bosch Hospital in Stuttgart lends its support in the development and testing of new healthcare solutions.
Bosch Healthcare Solutions includes four product areas: Laboratory Diagnostics (incl. the Vivalytic platform), Therapy Management, Connected Life, and HighTech Components. The Therapy Management area recently developed Vivatmo me, the first breath analysis device that allows asthmatics to measure the severity of airway inflammation.
BR: What is Vivalytic and when will it be commercialized?
MS: Vivalytic, a fully automatic PoNsystem for molecular diagnostics, was recently revealed to the public. Vivalytic will be available from Q32018 with initial tests. With Vivalytic, tests that previously could only be carried out with various devices or prepared manually are now possible in a single step: the sample is placed in a cartridge with minimal preparation, and processed in the sealed device. For clinical and laboratory staff, the learning curve is low. Ease of use is supported by the fact that the cartridges can be used over a long period of time without any special storage, and the reagents do not require cooling.
Vivalytic is also a space-saver, as it does not require peripheral devices like laptops, keyboards, barcode scanners, or filling stations.
BR: Can you also tell us about the end-users and Vivalytic’s use case?
MS: The portfolio is aimed at all laboratory customers, big and small. As well as being well-suited to large-scale labs and hospital laboratories, which will typically use Vivalytic for lower throughput and back-up analyzer applications, this platform will mesh very well with small-scale locations. Vivalytic’s ease-of-use and space-saving capability make it ideal for local clinics and medical practices, where it can support quicker sample-testing turnaround for doctors.
Courtesy of Bosch
BR: What are your technological strengths, and what makes Vivalytic really unique?
MS: Vivalytic is designed to be an open platform compatible with various manufacturers’ molecular diagnostic tests. The system supports all common test methods: end-point PCR, quantitative real-time PCR, melting curve analysis, and microarray technology. This means that single-plex, low-plex, and high multiplex tests are all possible on the same device. Depending on the test, various sample materials such as fluids, tissue samples, or sputum can be processed. Moreover, intelligent, programmable microfluidics allow viruses, bacteria, and fungi to be analyzed independently in two parallel processes.
BR: Can you further explain your plan for working with other companies and how they will benefit from Vivalytic’s versatility?
MS: Vivalytic’s business model offers assay developers and manufacturers of all sizes access to a fully automated PoC platform, along with relevant markets. For distributors, Vivalytic offers a continuously growing test portfolio.
Courtesy of Bosch
BR: Bosch is renowned in the automotive market. Does this new move mean that Bosch also intends to become a leader in the PoC diagnostics field?
MS: With Vivalytic, we are exploring a new field: laboratory diagnostics. Vivalytic is the result of more than 10 years of work in research and advanced development. By entering the laboratory diagnostics market, BHCS will position itself more broadly in the medical technology market. Bosch’s core skills in sensor technology, automation, miniaturization, and connectivity pave the way for Vivalytic, the new all-in-one solution. We are combining these skills with our partners’ test expertise in order to create an open platform.
Courtesy of Bosch
BR: How do you differentiate from your rivals in the highly competitive PoC industry?
MS: Vivalytic’s universal usability and wide applications range make it a unique all-in-one solution that also offers space-savings. Vivalytic is easy and intuitive to operate. For example, no cooling chain of reagents is required. Also, Vivalytic allows users to perform tests which look for specific pathogens or genetic changes (singleplex tests), and tests which look for several different pathogens simultaneously (multiplex tests) on one device. Various biological samples can be loaded into the cartridge without the need for preparation steps (native samples), i.e. tissue, fluids (blood, urine, liquor, swabs) stool, sputum, etc. Vivalytic processes the native samples, automatically isolating nucleic acids from the samples prior to each analysis.
Vivalytic supports the most popular laboratory detection methods, uniquely integrating all of them in a single system (i.e. microarray, melting curve, real time PCR, endpoint PCR). Also, Vivalytic requires no other peripheral devices: laptop, keyboard, barcode scanner, or filling stations, making it a hygienic, small-footprint solution. Thanks to the support of common standards such as HL7, GDT, and POCT1-A, our multifunctional platform can be integrated into the existing IT systems in hospitals or practices. The results are therefore immediately available to the people involved in the diagnostic process. These results are automatically processed and displayed for each user group individually, and can range from a short summary all the way up to the raw data associated with every single measurement.
BR: Can you describe the partnerships you already have in place?
MS: We have already established partnerships with Randox Laboratories and R-Biopharm. Randox is an ideal partner, with outstanding expertise in the field of molecular laboratory diagnostics. The first Randox assays available on Vivalytic will be the industry-leading Respiratory Multiplex, which simultaneously tests for 22 bacterial and viral pathogens, and the STI Multiplex, capable of detecting 10 STIs from a single patient sample.
With R-Biopharm, we have inspired another important partner for our platform with whom we can jointly expand Vivalytic’s test portfolio for clients. The Vivalytic platform will benefit from R-Biopharm’s expertise in developing and commercializing innovative diagnostic solutions. In the future, further partnerships will be concluded to expand the test portfolio.
BR: Does Bosch offer its partners exclusivity on the platform for a specific assay menu?
MS: We are convinced that an open, non-exclusive business model is of great benefit for both partners and customers.
BR: What are your expectations in terms of market penetration for Vivalytic? Do you have any numbers to share?
MS: Initially Vivalytic will be available in Europe, but we also strive for global availability.
BR: What can we expect from Bosch Healthcare in the next few years?
MS: Products that improve a person’s quality of life.
Martin Schulz earned an Electrical Engineering degree from the University of Applied Sciences Dusseldorf. He joined Bosch in 2003 and worked for seven years in Automotive Electronics in Germany and the US, and eight years in the medical and IVD fields in Germany and also the US. Today, Martin leads Bosch Healthcare Solutions’ Laboratory Diagnostics product area.
Dr. Benjamin Roussel is Director, Life Sciences and Healthcare at Yole Développement (Yole), part of Yole Group of Companies.
By supporting industrial companies and R&D institutes in their development, Benjamin and his team are creating the bridge between innovative microtechnologies and numerous diagnostic, pharmaceutical, life science and medical device applications.
Benjamin Roussel is the author of a large collection of market & technology reports focusing on bioMEMS, microfluidics and solid state medical imaging, and performs multiple custom consulting projects. Thanks to his deep knowledge of these industries and related technologies, he has spoken in more than 20 industry conferences worldwide over the last 5 years.
Before joining Yole, Benjamin worked in an International Pharmaceutical company in the pharmacovigilance department. He holds a Pharmacy diploma from the University Claude Bernard Lyon (France), in addition to a master’s degree in Technology & Innovation Management from EM Lyon Business School (France).
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