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November 2025
The leading international magazine for Clinical laboratory Equipment for everyone in the Vitro diagnostics
Prins Hendrikstraat 1
5611HH Eindhoven
The Netherlands
info@clinlabint.com
PanGlobal Media is not responsible for any error or omission that might occur in the electronic display of product or company data.
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Treponema Pallidum tests global market to reach $462m by 2028
, /in E-News /by 3wmediaThe global Treponema Pallidum (or Syphilis) tests market is projected to reach $462m by 2028, growing at a Compound Annual Growth Rate (CAGR) of 2.99% between 2018 and 2028, according to GlobalData, a leading data and analytics company.
www.globaldata.comThe company’s latest report, ‘Treponema Pallidum Tests – In Vitro Diagnostics Tests Analysis and Forecast Model’ reveals that North America and Asia Pacific will be the fastest growing regions with CAGRs of 3.28% and 3.44%, respectively, during the forecast period.
In many countries, the devices used for primary syphilis screening are changing and higher priced products such as chemiluminescence immunoassays and enzyme-linked immunosorbent assays are increasingly being employed. These newer devices are capable of high-throughput testing and enable institutions to reduce labor costs.
Alison Casey, Medical Devices Analyst at GlobalData comments: “A number of different factors influence growth of the Treponema Pallidum tests market; these include testing of infection and suspected infection cases as well as screening of pregnant women, anonymous sperm donations, whole blood donations, and source plasma donations.”
Barriers to market growth include declining rates of live births and whole blood donations, which are occurring in many countries and geographical regions.
Casey concludes, “While the rising global incidence of syphilis is expected to drive growth of the Treponema Pallidum Tests market, this is just one factor that must contend with multiple other variables that work together to determine future trends of this highly complex in vitro diagnostics market”
New annual report on cell and gene therapy market authorizations
, /in E-News /by 3wmediaISCT, the International Society for Cell and Gene Therapy, the global professional society of clinicians, researchers, regulatory specialists, technologists and industry partners in the cell and gene therapy sector, announced on November 20, 2018 the first publication of its new annual report detailing global cell and gene therapies (CGT) with market authorization.
www.celltherapysociety.orgwww.isct-unprovencellulartherapies.orgThe CGT market authorization report is intended to provide a centralized resource and increased clarity for all of those involved in the CGT industry. This involves the scientific community, healthcare stakeholders and patient associations. The report will be a regularly updated document that will be republished yearly, and accessible through the ISCT website.
The report has been designed to react to the increase in momentum around a widening number of CGT authorizations, as well as a parallel increase of unproven approaches where cells are delivered as treatments without rigorous scientific and regulatory assessment and authorization.
The report has been prepared by select members of the ISCT Presidential Task Force (PTF) on the Use of Unproven and/or Unethical Cell & Gene Therapies (UCGT) with lead authors Natividad Cuende (Executive Director, Andalusian Initiative for Advanced Therapies, Seville, Spain) and Laertis Ikonomou (Assistant Professor of Medicine, Boston University School of Medicine, Boston, MA). The ISCT Presidential Task Force was formed in 2014 to support ISCT’s ongoing commitment to address the rise of commercially available unproven or insufficiently proven CGT treatments. These approaches are targeted at hopeful individuals seeking cures or health improvement for a variety of conditions. The PTF-UCGT characterizes unproven cellular interventions and promotes safe and effective practices worldwide.
The reliable, up-to-date resource will help patients to make informed decisions before receiving a CGT treatment so that they can avoid being exposed to unproven and unlicensed cell interventions not approved by a regulatory or medicine agency.
The report also provides an annual breakdown of CGTs that have received, as well in some cases, have withdrawn, market approval. This includes analysis on types of product and therapy as well as disease targeted. 44 unique products were identified. 84% were cell and tissue therapies, and 55% were autologous. More than one third target oncological or hematologic conditions.
In the US, there are over 16 cell, tissue and gene products with marketing authorization, 14 in Korea, eight in Europe, four in India and Japan, two in Canada, and one each in China and Australia. This contrasts with Russia, Middle East, Africa, Central and South America, which have no CGT market authorizations or data available.
“The number of market approved cell and gene therapy treatments continues to grow, with a high number of other therapies seeking approval. It is critical for all those involved in the sector, and most importantly those patients that may benefit from newly approved treatments, to have an annually updated resource detailing all approved cell and gene therapies,” said Massimo Dominici, Chair of the ISCT Presidential Task Force on Unproven and Unethical Cell & Gene Therapies. “This resource will give patients visibility on what cell and gene therapies have gone through proper approval processes, and help them alongside physicians to make more informed decisions about their treatment.”
In tandem with the efforts of professional societies like ISCT, it is imperative that the regulatory environment and guidance keep pace with the rapid advancements in cell and gene therapy. As such, this report also supports ISCT the FDA’s continued publication of numerous draft CGT guidance documents in 2018.
Middle East IVF market worth US$1 billion as infertility rates rise to 15% in the region
, /in E-News /by 3wmediaThe latest research by Colliers International has revealed the current global In Vitro Fertilization (IVF) market is estimated to be between US$ 10 billion to US$ 12 billion, while the current IVF market size for Middle East & North Africa (MENA) is approximately US$ 1 billion, indicating a high demand for IVF and related treatments in the region.
www.medlabme.comThe figures, published in a new report titled “In Vitro Fertilization (IVF) & Fertility in the MENA region”, revealed that compared to 10% worldwide, infertility in the MENA region is 15% or higher, with male infertility a growing problem occurring in approximately 50% of the cases in the GCC and Middle East due to lifestyle, diabetes, obesity and genetics related factors, as GCC countries have one of the highest diabetic and obesity rates in the world.
The report, which is published as part of the MEDLAB Market Report series ahead of MEDLAB 2019 which takes place from 4 – 7 February at the Dubai World Trade Centre, highlighted that although the population in the MENA region has increased from over 100 million in 1950 to 380 million in 2017 and is expected to increase to 700 million by 2050, overall fertility rates have decreased from seven children per women in 1960 to just three in 2017.
The research provides an in-depth analysis of the fertility rates in MENA region and, despite overall high population growth rates, why IVF remains in demand in the region, especially in the GCC countries.
Commenting on some of the key insights on the UAE’s IVF industry, Mansoor Ahmed, Director Healthcare, Education & PPP for MENA Region at Colliers International, said: “IVF is not only sought after locally but is one of the leading treatments undertaken by medical tourists in the UAE, especially in Dubai. Based on Colliers’ discussions with leading operators, medical tourism accounts for 10% to 15% of the IVF patient volumes.”
According to the report, new innovations and improved testing techniques are gradually creating paradigm shifts in the field of assisted reproductive technology. Particularly the increased focus on pre-marital screening for consanguineous (relatives) couples and the development of new genetic tests for screening of the embryos greatly improves the chance of minimizing certain genetic diseases common in this region.
Dr Laura Melado, Specialist – Obstetrics & Gynecology, IVF, IVI Middle East Fertility Clinic, Abu Dhabi, UAE, who will be speaking at the Cytogenetics & IVF Conference during MEDLAB 2019, commented: “The Carrier Genetic Test (CGT) helps to determine the risk of having a child with a genetic disease. Anyone, without knowing, can be a carrier of one or more recessive mutations, but some couples have higher possibilities to carry the same genes. When this happens, Pre-implantation Genetic Testing (PGD) can be done for the embryos as part of the fertility treatment to help the couples to deliver healthy babies.”
Organized by Informa Exhibitions, MEDLAB Exhibition & Congress 2019 will welcome more than 19,600 medlical laboratory trade professionals and 670+ exhibitors from 46 countries in an effort to develop the value of laboratory medicine in shaping the future of healthcare and to provide advanced medical laboratory techniques for better health.
To download the “In Vitro Fertilization (IVF) & Fertility in the MENA region” report, please visit https://www.medlabme.com/en/forms/IVF-Fertility-MENA-2019-Report.html.
AllerGenis improves precision of food allergy diagnosis, assessment, and monitoring supported by Luminex xMAP® technology
, /in E-News /by 3wmediaData-driven food allergy diagnostics company, AllerGenis, LLC announced on January 16 that it has entered into a non-exclusive agreement with Luminex Corporation (NASDAQ: LMNX). According to the terms, AllerGenis will have the rights to develop, market and sell its novel precision food allergy diagnostic assay using Luminex’s xMAP® Technology.
http://www.allergenis.com/The agreement supports the upcoming 2019 commercialization of AllerGenis’ food allergy diagnostic platform, which more than triples diagnostic precision compared to current food allergy tests. AllerGenis’ high-throughput, peptide-bead assay breaks down allergenic proteins into smaller components, called epitopes. It then measures the reactivity of a patient’s antibodies to each epitope to generate a detailed reactivity profile that can provide clinicians a comprehensive solution with accurate information to better assess and manage that patient’s food allergies.
“Adopting Luminex’s bead-based xMAP® technology dramatically increased the power and scope of our food allergy diagnostic,” said Jim Garner, CEO and board member of AllerGenis. “We have been able to scientifically demonstrate the ability to identify food allergies with much higher precision over currently available blood tests. We’re very excited to enter into this agreement with Luminex to bring this much-needed technology to the clinical setting as soon as possible.”
AllerGenis’ peanut allergy assay will be the first product to launch supported by this agreement in the fall of 2019. The company is also developing a pipeline of assays across a wide range of food allergens using its epitope-based technology, as well as novel biomarkers.
Lack of regional research into precision medicine may hinder targeted therapies for cancers in the UAE
, /in E-News /by 3wmediaDubai, United Arab Emirates, 12th December 2018: Ahead of the upcoming MEDLAB Exhibition & Congress, the MENA region’s largest medical laboratory event, experts are highlighting the need for advancing genetic and disease research in the Arab world in order to provide targeted gene therapies for certain cancers for citizens in the UAE.
This is in line with the UAE Vision 2021 National Agenda, which aims to reduce cancer-related deaths in the country, with the World Health Organisation (WHO) estimating 25.6 deaths per 100,000 population in the UAE in 2017. To achieve this aim, the UAE government regularly launches national awareness and preventative campaigns within the framework of ‘Itmenan’ which involves the ‘Universal Periodic Examination’ and ‘Early Detection of Cancer’ initiatives adopted by the Council of Ministers.
Targeted therapies, or precision medicine, is defined as tailoring of medical treatment to the individual characteristics of each patient. It is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. For example, for cancer treatments, based on genetic testing, a physician can choose the most effective chemotherapy based on the mutation or biomarker identified.
According to the WHO, while 70% of deaths from cancer occur in low and middle-income countries, only one in five low and middle-income countries have the necessary data to drive cancer policy. More than 90% of high-income countries reported available treatment services compared to less than 30% in low-income countries. While a portion of countries in MENA do have a high GDP, they are still considered developing economies according to the United Nations.
Commenting, Dr Sara Sorrell, Consultant Family Medicine, Intercare Health Center, Abu Dhabi, UAE, said: “It is well recognised that Middle Eastern populations are underrepresented in disease research and, to date, there is no research to indicate the impact of precision medicine in the UAE. But I think that this is still premature as we don’t even have enough data on the general population genetics of this part of the world, so this is really the first step.
“For instance, if a different mutation is found to cause a particular cancer here, compared to European descent populations, this may present a novel target for new cancer therapies for local populations. Or, if a new drug comes on the market, what’s the effect in the local population? Therefore, advancing genetic and disease research in the UAE and the Arab world is very important. For this to occur, there needs to be both a focus on funding research as well as formulating policies around research and healthcare innovation to protect patients, scientists, and physicians,” she added.
Molecular diagnostics and genetics experts from the MENA region will gather at the upcoming MEDLAB Congress taking place from 4 – 7 February 2019 at Dubai World Trade Centre to discuss topics such as barriers to providing precision medicine in the Arab World, strategies for the prevention of genetic diseases, and Next-Generation Sequencing in oncology, among others.
Commenting on the importance of scientific exchange in the regional medical laboratory industry, Rejoy Penacerrada, Conference Director, MEDLAB Congress, said: “The conferences provide an important platform for the region’s medical laboratory community to engage in discussion that will promote the role of genetic and population research in advancing the health of citizens across the region. This is led by the intense interest in precision medicine, with the region’s laboratories now actively expanding their test menus for more personalised diagnostic services.”
Organised by Informa Exhibitions, the MEDLAB Congress brings together more than 6,700 conference delegates to hear from more than 110 speakers from 20 countries in an effort to provide advanced medical laboratory techniques for better health.
For a closer look at MEDLAB 2019, please visit www.medlabme.com
Evolution of signaling molecules opens door to new sepsis therapy approaches
, /in E-News /by 3wmediaThe numbers are alarming: According to estimates by the World Health Organization (WHO), around six million people die every year from sepsis. The disease, popularly called "blood poisoning", normally starts with a harmless infection.
If this triggers an excessive reaction of the immune system, the body’s own tissue can be attacked and damaged. The overreaction eventually leads to a life-threatening collapse of the body’s defenses. In Germany alone, more people die of sepsis than of AIDS, colon cancer and breast cancer combined.
Researchers around the world are on the search for new therapies – so far in vain. An interdisciplinary team from the fields of structural biology, immunology and cell biology has now, for the first time, successfully produced a protein that could balance the overshooting immune response.
In their work, the scientists were inspired by evolution: mice are well protected from sepsis by their immune systems. Here, interleukins – messengers, that mediate communication between the cells of the immune system – play a key role.
"The interleukins are the vocabulary with which immune cells communicate," explains Matthias Feige, Professor of Cellular Protein Biochemistry at the Technical University of Munich. The cells form these messenger molecules according to a very specific blueprint of individual amino acids. Their arrangement determines, which three-dimensional structure an interleukin adopts and, consequently, which information it transmits.
Humans and mice have similar, yet different vocabularies. The researchers discovered one striking difference in interleukin-27-alpha. This molecule can be released by cells of the mouse immune system – but not by human cells – and regulates immune cell function.
"Using computer models and cell biological experiments, we discovered that a single structurally important amino acid defines whether interleukin-27-alpha is released by cells of the immune system," explains Stephanie Müller, the first author of the study. "That gave us an idea about how we can engineer novel human interleukin proteins that are released by cells so that we can produce them biotechnologically."
The team then prepared the modified interleukin in the laboratory and tested its biological functions – with very encouraging results: The engineered messenger molecule is recognized by human cells. First analyses suggest that it can indeed balance an overreaction of the immune system, making it a promising candidate for sepsis therapy.
"Our approach allowed us to rationally extend the language of immune cells by engineering a key signaling molecule. This provides us with an opportunity to modulate the reaction of immune cells in a targeted manner. Such a finding was only possible thanks to the close collaboration with immunologists and clinicians from TUM, the Université Sorbonne in Paris and the Helmholtz Zentrum Muenchen," says Feige. A patent for the new protein is already pending.
https://www.tum.de/nc/en/about-tum/news/press-releases/detail/article/35210/
New combined diagnostic and antimicrobial susceptibility test enables resistance-guided therapy for gonorrhoea
, /in E-News /by 3wmediaUK 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.
https://plexpcr.comEuropean Clinical Research Alliance on Infectious Diseases (ECRAID)
, /in E-News /by 3wmediaOn January 17 global networks and key stakeholders discussed ECRAID and its sustainable solutions to protect Europe from antimicrobial resistance and emerging threats. Kicked off on January 17th 2019 with a high-level meeting in Brussels, PREPARE and COMBACTE have commenced the development of the business plan for ECRAID, the European Clinical Research Alliance on Infectious Diseases. ECRAID envisages a European-wide sustainable clinical research organization for infectious diseases and antimicrobial resistance that stems from both PREPARE and COMBACTE. The Kick-off Meeting opened with prominent speakers such as Marc Bonten, Coordinator of COMBACTE; Herman Goossens, Coordinator of PREPARE; Carlos Moedas, the EU Commissioner for Research, Science and Innovation; Jeremy Farrar, Director of Wellcome Trust; and Magda Chlebus, Executive Director, Science Policy & Regulatory Affairs, EFPIA. In addition, there were panel discussions with the participation of clinical research networks, such as African EDCTP-funded and Latin-America EU-funded organizations, preclinical research networks, SMEs, and pharmaceutical and diagnostic companies. ECRAID’s vision is to establish a coordinated and permanent European clinical research infrastructure for clinical research on infectious diseases. Due to their network, which is built on the foundations laid by COMBACTE (>950 clinical care sites) and PREPARE (primary care sites), ECRAID will be able to conduct clinical research faster and easier. Moreover, ECRAID will have rapid access to and knowledge of well-developed clinical and laboratory sites. Trials will be conducted continuously, allowing them to expand their experience and knowledge. ECRAID aims to protect public health by generating rigorous evidence to improve diagnosis, prevention, and treatment. The mission is to cultivate world-class research to protect citizens of Europe against antimicrobial resistance and infectious diseases over the long-term.
http://www.prepare-europe.eu/https://www.combacte.com/New blood test helps clinicians identify potentially life-threatening Ara h 6 peanut sensitization
, /in E-News /by 3wmediaPromising biomarker for vascular disease relapse revealed
, /in E-News /by 3wmediaResearchers at Okayama University report in the journal Arthritis & Rheumatology that monitoring a particular antigen can be used for predicting relapse of the vascular disease AAV.
www.okayama-u.ac.jp/index_e.htmlAntibodies are molecules produced by a human’s immune system to counteract bacteria and viruses. When a bacterial or viral pathogenic molecule (a so-called antigen) is detected, an antibody neutralizes it by binding to it. However, autoantibodies are sometimes produced against our own protein and cause autoimmune diseases. For the autoantibody known as ANCA (antineutrophil cytoplasmic antibody) cause ANCA-associated vasculitis (AAV), at least two antigens exist: proteinase 3 and myeloperoxidase (abbreviated as PR3 and MPO, respectively).
Assistant Professor Haruki Watanabe and Associate Professor Ken-Ei Sada from Okayama University and colleagues have now investigated whether MPO-ANCA can be used as a biomarker for the relapse of AAV, a blood-vessel inflammation disease. The researchers’ findings suggest that monitoring MPO-ANCA is useful for predicting relapse in patients with AAV.
The scientists looked at data for 271 MPO-ANCA-positive patients who had achieved remission (disappearance of the signs and symptoms) of AAV during 6 months after therapy was started. Levels of MPO-ANCA were measured at several times in a 2-year period. Assistant Professor Haruki Watanabe and Associate Professor Ken-Ei Sada from Okayama University and colleagues found that for 72% of the patients, MPO-ANCA levels decreased to normal within 6 months after therapy began. MPO-ANCA reappeared for 40% of the patients for which there were complete follow-up data; this reappearance was associated with a relapse occurring simultaneously or later. The researchers therefore concluded that reappearance of MPO-ANCA is a promising marker for AAV relapse.
Assistant Professor Haruki Watanabe and Associate Professor Ken-Ei Sada from Okayama University and colleagues found indications that MPO-ANCA reappearance could be particularly useful as a biomarker for relapse of AAV with kidney involvement (renal AAV). Since only 4 patients without renal involvement experienced relapse, a larger study would be necessary to establish any link between MPO-ANCA reappearance and relapse of non-renal AAV.
The researchers point out that their study has some limitations: the data were obtained earlier, in the context of other investigations, and different participating institutions used different analytic procedures for qualitatively assessing ANCA content. Nevertheless, the study was the largest so far, and also the first with case–control analysis (based on comparisons of patients with and without the disease relapse). Watanabe and colleagues conclude that for patients recovered from MPO-AAV, “routine MPO-ANCA monitoring should be implemented [to predict possible relapse]”.