QIAGEN announced on August 1st that its careHPV™ Test, one of the only molecular diagnostics for high-risk human papillomavirus (HPV) designed to screen women in low-resource settings, has been added to the World Health Organization (WHO) list of prequalified in vitro diagnostics (IVDs). HPV is the primary cause of cervical cancer, so screening women for the presence of the virus is a critical aspect for prevention and early treatment of the deadly cancer. The careHPV Test was launched globally in 2010 and through numerous pilot studies has demonstrated to be a more sensitive alternative to cytology and visual inspection based methods for the detection of pre-cancerous cell abnormalities. The WHO’s evidence-based listing is expected to expand the availability of this critical diagnostic tool in countries that rely on the global organization’s list in making purchasing decisions. The WHO Prequalification status will significantly broaden access to HPV DNA testing to areas of the world with a high burden of cervical cancer.
 
“The WHO prequalified IVD listing is a ‘stamp of approval’ for our innovative careHPV Test, and this will encourage authorities to adopt efficient, highly accurate HPV screening for prevention of cervical cancer in settings with limited healthcare infrastructure,” said Thierry Bernard, Senior Vice President, Molecular Diagnostics Business Area, for QIAGEN. “China routinely uses careHPV in rural or low-resource areas, and QIAGEN partners with non-governmental organizations and health ministries in developing countries. We expect the WHO listing to drive further dissemination of this important tool for women’s health.”
 
QIAGEN’s fast, portable and easy-to-use careHPV Test combines the power of advanced molecular technologies with innovative design features for areas lacking consistent electricity, water or a controlled laboratory environment. For example, the system has color-coded, easy-to-understand menus and self-contained reagents. The test tolerates temperature variations that occur in rural clinics lacking refrigeration due to limited electricity or water, and can provide results much faster than traditional laboratory based methodologies. The careHPV Test was developed with support from PATH, an international nonprofit organization, and is manufactured by QIAGEN in Shenzhen, China.
 
“High-quality molecular HPV tests that are easy to run are critical for expansion of cervical cancer prevention strategies in low-resource settings. WHO prequalification of careHPV is excellent news that will help countries to choose the best and most suitable technology for their programs. To achieve higher coverage of at-risk women and make an impact in cervical cancer prevention, we need to move to affordable and cost-effective strategies with HPV testing leveraging self-sampling potentially,” said Dr. Silvia de Sanjosé, Director of Scale-Up project at PATH, a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges.
 
The careHPV Test for low-resource settings is highly complementary with QIAGEN’s digene HC2 HPV Test, the world’s most validated and sensitive diagnostic test for detection of high-risk HPV. The digene HC2 HPV Test is recognized as the “gold standard” in HPV screening and is widely used in developed countries and in large cities in emerging markets.
 
Cervical cancer is the fourth most common cancer among women worldwide, with an estimated 528,000 new cases and 266,000 deaths in 2012, the most recent year for which WHO publishes statistics. An estimated 80% of new cases and deaths occur in developing countries, where awareness of the disease and access to preventive tests and medical treatment is low. In many low-resource areas, cervical cancer has eclipsed breast cancer as the primary cancer killer of women.

In the year of its 50th anniversary in Europe, Shimadzu has been awarded the NRW.INVEST Award 2018 for outstanding investments and commitment to the location. This prestigious award is presented by North Rhine-Westphalia (NRW), Germany’s industrial heartland and most populated federal state. Andreas Pinkwart, Minister of Economics and Digitalization, presented the award in Düsseldorf at the end of June. Founded in 1968 with five employees, Shimadzu today supervises more than 700 employees across Europe from its European headquarters in Duisburg. The city is also home to Shimadzu’s European Innovation Center, a think tank that combines academic and scientific know-how from universities with Shimadzu’s high-quality analytical technologies to design new solutions for tomorrow. "Merging analytical and medical technology methods breaks new grounds in diagnosis and treatment, especially of endocrine disorders, cancer and dementia," says Jürgen Kwass, Managing Director Shimadzu Europe. "These include, for example, chromatography/mass spectrometry combined with angiography or near-infrared photoimmunotherapy."

In late July, Svar Life Science signed a strategic agreement to transfer the portfolio of radioimmunoassays (RIA) and the Chromogranin A Neolisa™ (ELISA) product to DIAsource ImmunoAssays, a BioVendor group company.
Svar Life Science AB (formerly Euro Diagnostica AB), a Swedish life science company that has been working across the clinical diagnostic value chain for over 30 years, and DIAsource ImmunoAssays, a leading diagnostics company delivering manual RIA and ELISA kits and open automation solutions to international markets, today announced a strategic agreement, under which Svar Life Science will transfer its portfolio of RIA products and the Neolisa™ CgA ELISA product to DIAsource, securing the continued production and sales of these products.
Svar Life Science will continue to invent, develop and apply the best analytical technologies, with a focus on helping deliver the answers needed in drug discovery and clinical diagnostics, and the impact this has on human lives.
This transaction strengthens DIAsource and BioVendor’s position as one of the top RIA and larger ELISA manufacturers, committed to servicing customers worldwide that use manual assays and open automation to complement their portfolio on closed automated systems.
The portfolio to be transferred includes the complete line of radioimmunoassays for the quantification of a number of peptide hormones involved in critical physiological processes. These endocrinological parameters are mainly used as tumour markers and for diabetology and salt balance analysis. The portfolio transfer also includes the ELISA Chromogranin A Neolisa™ product which complements the RIA Chromogranin A product.
In order to support a smooth transition with minimal disruption for customers, the companies have agreed to a transition period. Starting 1st of September 2018 DIAsource ImmunoAssays assumes sales of the RIA product portfolio. During the remainder of 2018 the RIA production will be transferred. Sales of the Neolisa™ CgA ELISA product will be assumed by DIAsource as of January 2019, with production transfer to follow during 2019.
Ron Long, CEO, Svar Life Science, said: “The agreement with DIAsource ImmunoAssays forms part of our strategy of focusing our product portfolio and core technologies to help deliver the answers needed in drug discovery and clinical diagnostics today. It also enables us to strengthen our support for life science customers providing high quality solutions, the best analytical technologies for drug development and clinical research.
DIAsource ImmunoAssays are committed to being a complete diagnostic provider and we’re confident that this agreement enables them to increase their support for customers in the field of radioimmunoassays.”  
Jef Vangenechten, CEO of DIAsource ImmunoAssays, said: “This acquisition is another step in our strategy to position DIAsource as a consolidator of manual specialty assays, after previous acquisitions of the Intertech RIA product line in 2012, Viro-Immun ELISA and IFA product lines in 2017, and more recently the RIA product line from ZenTech.”www.diasource-diagnostics.com

IDTechEx Research has recently released a new market report ‘Technology for Diabetes Management, 2019-2029: Technology, Players and Forecasts’, including details of glucose test strips, continuous glucose monitoring (CGM), insulin pumps, insulin pens, digital health / digital therapeutics, side effect management and diagnosis.

The report covers the entire landscape for diabetes management devices, including mature, emerging and future options. The report has been researched via primary interviews with companies, physicians and diabetic individuals to characterize and predict the technology landscape for diabetes devices over the coming decade. In total, activities of 75 companies are covered throughout the report, ranging from the largest players to technology developers and startups developing the next generation of device options.

Historically, diabetics have monitored their blood glucose concentration by using disposable biosensors; following a finger prick, a drop of blood is placed onto a glucose test strip, which is inserted into a reader to provide the result. Whilst billions of test strips are produced each year, this sector as seen profitability shrink due to changing medical subsidies and increased competition. Alternative options have been developed to enable continuous glucose monitoring. These involve devices that are typically worn on the skin, using a sensor on a small needle to test glucose in interstitial fluid. There are now approved devices from several key players, with this industry growing each year.

However, challenges still remain with glucose monitoring devices, with the ultimate aim of providing the best experience for diabetics. CGM devices in the past have been reliant on test strips for calibration, as well as still being invasive or implantable, leading to discomfort. This has led to many players investigating glucose monitoring options which are less invasive, whilst maintaining the required accuracy and reliability. In addition, the possibility of pairing CGM devices with insulin pumps for increasingly automated "closed-loop" systems is becoming increasingly closer. These goals have been in place for decades, and the report follows all the latest news, trends and outlook in each of these technology frontiers around diabetes management devices.

However, managing diabetes is about more than just monitoring glucose levels. The report also covers other aspects of diabetes technology landscape, including insulin delivery, the role of digital health in diabetes, technology for managing side effects, technology for diagnosis and reimbursement, funding and investment examples. The report then includes detailed market forecast following two different methodologies. The first involves the collection of revenue data from companies throughout the space, with historic data back to 2010 by company and by sector. This is then projected given a series of assumptions based on IDTechEx’s primary research efforts. The second forecast scenario involves looking at data for the diabetic population, including number of diabetics, split by type, percentage diagnosis, and then adoption rates by device type for each group. The two forecasts are then discussed and compared, providing with the reader with ample content from which to base business decisions and understand the dynamics in the space.

As discussed, the report is split into 8 main chapters, discussing each aspect of diabetes management technology (not including pharmaceutical options). Following an executive summary, detailing the main conclusions and discussion of the report, the report introduces the challenges and opportunities in diabetes management, as well as going through the main patent holders and filing trends in the space. Then, topic chapters of the report are as follows:

• Sensors for diabetes management: This chapter includes coverage of glucose sensing, from test strips and glucometers, to continuous glucose monitoring (CGM), and through to a discussion of emerging options in this space. In total, 37 different companies are mentioned in this section, ranging from the largest players in tests strips and CGM (e.g. Abbott, Roche, Medtronic, Dexcom, etc.) through to many emerging players or innovators attempting new approaches to glucose monitoring.
• Insulin delivery: This chapter covers techniques from traditional vial-and-syringe and insulin pens, to insulin pumps and towards closed loop insulin delivery alongside CGM. Key trends discussed in this section include the integration of different connectivity and technology integrated alongside both insulin pump and insulin pens, the links from these devices into wider digital health ecosystems and the adoption of newer devices (particularly insulin pumps) by territory and demographic.
• Digital health: Chronic diseases are a prominent early target for those in the digital health ecosystem, and digital health options for diabetes have been prominent. This chapter discusses activities from both the small and larger players, including major acquisitions and collaborations, in areas including diabetes management systems, device companion software and digital therapeutics.
• Side effect management: The majority of the costs associated with diabetes are around managing side effects. This section focuses on new technology options emerging around areas such as diabetic neuropathy, foot ulcers and ketoacidosis. This includes various wearable, flexible and textile-based technology options.
• Diabetes diagnosis: discussing the use of emerging technologies to aid the early detection of diabetes, thereby preventing long hospital stays and other complications.
• Reimbursement options, funding and investment examples: These final elements to the report fill in details which are important for the broader space. Reimbursement, whether through insurers, national healthcare initiatives or otherwise, is still critical for the majority of diabetes devices. Funding and investment are also present, as with any large, transforming industry.

Over 75 companies are mentioned in the report, including many primary interviews, a patent analysis of the key patent-holders, and revenue data where relevant.