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.

The European Organisation for Research and Treatment of Cancer (EORTC) Brain Tumor Group and Protagen AG today announced a collaboration to utilize Protagen’s Cancer Immunotherapy Array to identify autoantibody biomarkers that investigate the immunological profile and immuno-competence of long-term Glioblastoma survivors.
Glioblastoma is the most common glial brain tumor with an annual incidence above 3 per 100,000 population. The overall prognosis of glioblastoma patients remains poor. According to population-based data, median overall survival (OS) is still in the range of only one year and long-term survival is rare. However, a minority of glioblastoma patients survive for more than 60 months and these individuals are referred to as long-term survivors. The US-based Brain Tumor Funders Collaborative (BTFC) is supporting a large international research program that aims at better understanding which individuals with glioblastoma will ultimately become long-term survivors.
Through the present new collaboration, Protagen and the EORTC Brain Tumor Group will utilize Protagen’s Cancer Immunotherapy Array to understand the immunological profile of such patients to learn how to predict such long-term survival and potentially define novel pathways for therapeutic intervention.
Prof. Michael Weller, Head of the Brain Tumor Center at University Hospital Zurich and Chairman of the EORTC Brain Tumor Group, stated: “In our network we have followed and investigated this group of long-term glioblastoma survivors for many years. The focus has been to understand the molecular profile of these patients and thus over the years we have gained a much better understanding. However, we really need to understand the immunological profile and the immuno-competence of these patients better. Thus, investigating these patients by utilizing Protagen’s Cancer Immunotherapy Array may enable us to define their immune-profile, so that we can assess their immuno-competence. This will help us, together with the data already collected, to potentially understand why these patients survive for so long and how this can be extrapolated to other patients suffering from glioblastoma.”
Dr. Peter Schulz-Knappe, Protagen’s Chief Scientific Officer, commented: “Our unique Cancer Immunotherapy Array has already demonstrated its potential for the prediction of therapeutic response and immune-related adverse events in Immuno-Oncology. The extension into Glioblastoma with a specific view to studying long-term survivors with one of the deadliest tumors provides a great opportunity to apply the Array for the prediction of survival but also to learn more about potential novel pathways for therapeutic intervention. Thus, we believe that applying our technology will result in a better understanding of the immunological profile of these long-term survivors which will benefit all patients suffering from Glioblastoma. We feel privileged that the EORTC Brain Tumor Group shares this vision, and are excited about the collaboration.”

Researchers at the University of Helsinki have developed a new mouse model of congenital anomalies of kidney and urinary tract and disease progression.
About one in every 100 babies is born with some kind of developmental anomaly in the urogenital tract. In most cases abnormalities are mild, but sometimes life-long and even life-threatening disease develops.
Infertility is another important aspect that associates with urogenital anomalies. Therefore understanding how those features occur is instrumental in developing future treatments.
To date, diseases which scientist understand the best are those caused by mutations in the proteins involved. However, in many diseases such mutations are not found, and the disease is “idiopathic” or referred as without a known cause, and maybe triggered by e.g. environmental factors.
Classically scientists have studied such cases by injecting many copies of the gene of interest into fertilized egg of an experimental animal. However, the major problem with this technique is that scientist have almost no control over where in the genome the gene lands, and what cell types start to produce the encoded protein.
By employing an unconventional genome engineering trick that increased glial cell line-derived neurotrophic factor (GDNF) production 3-6 times, scientists revealed that ureter, which allows urine produced by kidneys to enter bladder, length is regulated by GDNF levels, and that tubes connecting testicles to reproductive organs are misplaced when there is too much GDNF, resulting in infertility in males.
GDNF is a secreted protein which signals growth and survival for many types of cells. In females, too much GDNF resulted in imperforated vagina or lack of vaginal opening, resulting in infertility.
The researchers were able to trace some of those defects back to altered stem cell behaviour in the developing urogenital block and identified some signalling pathways involved. Collectively these findings provide new information on altered stem cell behaviour in the developing kidney.
University of Helsinki https://tinyurl.com/y6oag6xr

The longest FlexLab automation system ever produced by Inpeco has been designed for a mega volume reference laboratory customer, Hermes Pardini group based in Minas Gerais, Brazil. Siemens Healthineers (Inpeco’s strategic automation partner who sold the solution) is implementing the FlexLab system for Hermes Pardini’s “Enterprise” project, which will result in the largest laboratory automation platform in the world, linking more than 100 analyzers and 7 clinical specialties.
The Hermes Pardini Group is highly innovative in diagnostics medicine, and will handle 110 million sample tubes every year to address diagnostic testing needs of patients and healthcare providers from all across Brazil. The Enterprise project is expected to be operating at its full capacity in 2019, and will automate the distribution of sample tubes to nearly 100 different analyzers with a total length of 330 meters, which will include more than 70 pre- and postanalytical modules to eliminate the need for error-prone and time-consuming manual interventions within the clinical laboratory. It is to be installed in the Vespasiano site (Belo Horizonte area) in the current laboratory testing area (3,500 square meters of floor space).
“Unlike conventional laboratory set-ups, where sample tubes must be moved manually between different analyzers, our enterprise lab will employ a ‘one-touch, one workflow’ concept to eliminate the need for manual interventions, ensure sample traceability, and reduce the turnaround time to results,” said Guilherme Collares, Chief Operations Officer of the Hermes Pardini Group.
Inpeco’s High Throughput FlexLab solution will contribute to make this concept a reality, and enable providers to receive results faster, thereby enabling better patient care. The project also includes refrigerated storage units, with capacity to hold more than 1.3 million samples, and a newly developed advanced vision system, which is able to detect sample deterioration such as hemolysis, icterus or lipemia. “We’ve been in touch with Hermes Pardini since they began 2 evaluating options to replace the automation system they were using – said Andrea Pedrazzini, President of Inpeco – and we are extremely proud and pleased that such a prestigious institution has decided to adopt the largest FlexLab system ever built to fully automate their samples process, from loading to storing and disposing.”

http://www.inpeco.com/en/

UK patients with N. gonorrhoeae (GC) now have the option of receiving the cheap and easily-administered oral antibiotic ciprofloxacin thanks to updated treatment guidelines and the availability of a novel molecular diagnostic and antimicrobial susceptibility test (AST). The new test can simultaneously diagnose gonorrhoea and provide information on whether a patient will respond to ciprofloxacin.

Global management strategies for antimicrobial resistance (AMR), such as those developed by the World Health Organisation, highlight gonorrhoea as a priority infection to manage, with more effective use of diagnostic tools listed as a key focus for future development. On 24 January 2019 the Health Secretary Matt Hancock, launched the UK government’s 20-year vision to combat antibiotic resistance at the World Economic Forum at Davos, Switzerland.

Ciprofloxacin was the first line antibiotic of choice for uncomplicated gonorrhoea in the past but was relegated to an alternative treatment due to increasing resistance.

The incidence of sexually transmitted infections (STIs) including gonorrhoea is increasing around the world, with corresponding increasing rates of resistance to commonly used antibiotics. The first two cases of multidrug-resistant (MDX) N. gonorrhoeae were reported in the UK at the start of 2019. These follow the first globally reported case of gonorrhoea with high-level resistance to azithromycin and resistance to ceftriaxone in England in 2018.

Called ResistancePlus® GC, the availability of the new test is timely, as the British Association of Sexual Health and HIV (BASHH) has launched its 2019 gonorrhoea management guidelines to include the use of ciprofloxacin, provided antimicrobial susceptibility results are available prior to treatment.

The new test could be critical in the battle against antibiotic resistance, helping physicians to prescribe an effective antibiotic using a resistance-guided approach. Prior to the new 2019 BASHH guidelines, ceftriaxone was the recommended front-line treatment for gonorrhoea together with azithromycin. Ceftriaxone is a painful intramuscular injection. It has long been considered the last readily available effective antibiotic for GC, and several extensively drug-resistant strains have now been isolated exhibiting resistance to ceftriaxone and many other available treatments.

“The new guideline now recommends giving double the previously recommended dose of ceftriaxone (now 1g stat). However, they also indicate ciprofloxacin as a first-line option when antimicrobial susceptibility is known prior to treatment.
Not only is this less painful for patients, it is preferable to doctors as it is a cheaper treatment that does not require specialised staff to administer the injection.

As the UK now has the lowest reported rate of ciprofloxacin-resistant gonorrhoea at 26%, over 70% of patients could now benefit from the new guidelines and receive oral therapy if they have a test result showing ciprofloxacin susceptibility, such as is offered by the test.
ResistancePlus® GC was invented by scientists in Australia and is now able to be accessed by clinicians in the UK. It is the first commercially available molecular diagnostic test providing ciprofloxacin susceptibility information and is well placed to support current laboratory molecular testing workflows. Currently, culture methods are the routine test to determine antimicrobial susceptibility, but results can take days to produce, and many rectal (50%) and the majority of throat (70%) samples can be difficult to culture; ResistancePlus® GC can overcome these limitations.

Treating gonorrhoea as soon as possible is very important because gonorrhoea can lead to serious long-term health problems including pelvic inflammatory disease (PID) in women, that may result in infertility, and infection in the testicles in men.

SpeeDx, the company behind the new test, received CE-IVD marking for its ResistancePlus® GC assay at the end of 2018, enabling it to be adopted in all countries where CE-mark is accepted – including the UK. It is based on a PlexPCR method that detects both N. gonorrhoeae (GC) and sequences in the gyrA gene of the bacteria associated with susceptibility to ciprofloxacin, in a single test.