EUROIMMUNBlog Medizinische Labordiagnostika AG

  • From Saul to Paul
    by Gastautor on March 5, 2021 at 7:50 pm

    Guest contribution: Article series on the subject of state-of-the-art mycology in dermatology, 1st article by Prof Hans-Jürgen Tietz, Director of the Institute of Fungal Diseases in Berlin, Germany Mycology is one of the most beautiful faces of dermatology. To admire… Der Beitrag From Saul to Paul erschien zuerst auf EUROIMMUNBlog.

  • EUROIMMUN Launches SARS-CoV-2 Test System to Detect T-Cell Response
    by Dr. Johanna Fraune on January 14, 2021 at 1:48 pm

    Press Release Novel test supports vaccine development studies critical to aiding researchers in understanding immunity levels and disease progression EUROIMMUN, a PerkinElmer company, today announced that is has launched a SARS-CoV-2 Interferon Gamma Release Assay (IGRA) for Research Use Only… Der Beitrag EUROIMMUN Launches SARS-CoV-2 Test System to Detect T-Cell Response erschien zuerst auf EUROIMMUNBlog.

  • Now possible: Quantitative anti-SARS-CoV-2 IgG determination in standardised units
    by Dr. Elke Brüsehaber on January 12, 2021 at 1:08 pm

    Anti-SARS-CoV-2 antibody standard preparation from the WHO now available Since end of December 2020, the first international reference material, “First WHO International Standard Anti-SARS-CoV-2 Immunoglobulin”, has been available for the standardisation of results of Anti-SARS-CoV-2 antibody test systems. An excellent… Der Beitrag Now possible: Quantitative anti-SARS-CoV-2 IgG determination in standardised units erschien zuerst auf EUROIMMUNBlog.

  • Novel ELISA for Detection of SARS-CoV-2 Antigen in Acutely Infected COVID-19-Patients
    by Dr. Johanna Fraune on December 16, 2020 at 4:16 pm

    Press release Automatable  and reliable COVID-19 test rounds out Company’s menu of offerings for acute diagnostics of the virus EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the… Der Beitrag Novel ELISA for Detection of SARS-CoV-2 Antigen in Acutely Infected COVID-19-Patients erschien zuerst auf EUROIMMUNBlog.

  • New PCR Test to Differentiate Between COVID-19 and Flu
    by Dr. Johanna Fraune on December 14, 2020 at 3:51 pm

    Press release Company expands testing portfolio for acute diagnostics of COVID-19 EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked EURORealTime SARS-CoV-2/Influenza A/B for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type… Der Beitrag New PCR Test to Differentiate Between COVID-19 and Flu erschien zuerst auf EUROIMMUNBlog.

  • Superiority of Orsiro DES Over Xience DES Confirmed in STEMI Patients
    on March 15, 2021 at 1:42 pm

    BIOTRONIK’s ultrathin-strut stent, Orsiro®*, demonstrated superiority over Xience DES for target lesion failure (TLF) at 24 months, according to new follow-up data from the BIOSTEMI trial.1The latest results were presented by Prof. Thomas Pilgrim, Inselspital Bern, University Hospital, Bern, Switzerland, who unveiled them in a late-breaking session at CRT 2021. The results of this randomized controlled trial have also been published in JACC Cardiovascular Interventions.2Most drug eluting stent trials are powered only to demonstrate non-inferiority. BIOSTEMI is a rare trial that demonstrates the superiority between two contemporary DES in patients presenting with acute ST-segment elevation myocardial infarction (STEMI).Caused by a complete thrombotic occlusion in a coronary vessel, STEMI is the most acute manifestation of coronary artery disease, with substantial rates of morbidity and mortality.3 STEMI patients represent about 30% of all primary percutaneous coronary intervention (PCI) cases.4“In contrast to the primary endpoint data at one-year, two-year data show a significant difference between the two treatment arms, not only using Bayesian statistics incorporating a historical prior from the BIOSCIENCE trial, but also when analyzed as an independent clinical trial,” explained Principal Investigator Prof. Pilgrim.BIOSTEMI is an investigator-initiated, multicenter, superiority trial, using a Bayesian design, to compare biodegradable-polymer, sirolimus-eluting stents to durable-polymer, everolimus-eluting stents in 1,300 patients with acute myocardial infarction. The ultrathin-strut Orsiro DES demonstrated superiority in the clinical primary endpoint of TLF5 at 12 months, which was further confirmed at 24 months with an incidence of 5.1%. In comparison, the Xience DES, showed an incidence of 8.1% at 24 months (Rate Ratio 0.58, 95% Bayesian credible interval, 0.40-0.84; posterior probability of superiority, 99.8%).The difference remained significant after the exclusion of historical data from the BIOSCIENCE trial with only the BIOSTEMI patients being analyzed (Rate Ratio 0.62, 95% Bayesian credible interval, 0.40-0.96; posterior probability of superiority, 98.5%). The difference was driven by a lower incidence of clinically indicated, target lesion revascularization (TLR). No significant difference was observed between the two treatment arms for safety endpoints.“The BIOSTEMI outcomes at 24 months demonstrate the unequivocal superiority of ultrathin strut Orsiro DES over Xience DES,” commented Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. “In my opinion this data should define a new standard of care in the treatment of STEMI patients, what would you choose for your heart?"- END -References:1 Pilgrim T, Randomized Comparison Of Biodegradable Polymer Sirolimus-eluting Stents Versus Durable Polymer Everolimus-eluting Stents In Patients With ST-segment Elevation Myocardial Infarction: Final 2-year Outcomes Of The BIOSTEMI Randomized Trial. Presented at virtual CRT2021, March 13, 2021.2 Pilgrim et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011. 3 Vogel B et al. ST-segment elevation myocardial infarction; Nature Reviews Disease Primers. 2019; 5(1):39.4 Fokkema ML et al. Outcome after percutaneous coronary intervention for different indications: long-term results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). EuroIntervention. 2016; 12(3):303-11. 5 Target lesion failure is a combined endpoint of cardiac death, target vessel myocardial reinfarction, and ischemia-driven target lesion revascularization, representing measures of safety and efficacy. *Orsiro DES is not currently indicated for STEMI patients.Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.Xience is a trademark or registered trademark of the Abbott Group of Companies.

  • How Do We Support Women In Advancing Their Scientific Careers?
    on March 8, 2021 at 9:30 am

    As we mark International Women’s Day in 2021, we’ve been reflecting on the invaluable contributions women make to science, technology, and clinical research. Women have long been at the forefront of scientific advances and this past year was no exception—as the first approved COVID—19 vaccine demonstrates. In 2021, BIOTRONIK celebrates its ninth year of partnership with Club Lise—an initiative to encourage and mentor young women interested in a scientific career, which we profiled last month for the International Day of Girls and Young Women in Science. A few months ago we also saw the enrolment success of the BIO-LIBRA study. The study aims to help address the underrepresentation of women in certain clinical studies, by enrolling over 40% women, to see if they respond the same way as men to cardiac device therapy.But there is still a way to go. Recent UNESCO statistics find women in STEM fields (science, technology, engineering and mathematics) publish less, are paid less for their research, and do not experience the same career progression as their male colleagues. In the second part of our series of contributions from women in technical positions at BIOTRONIK, we asked our panel about how to support women as they progress in their scientific careers. What needs to change, and importantly, what already works?Acknowledging—and Embracing—Different Experiences“I do think women have other challenges, because we are perceived differently and because men and women have mutual prejudices that cannot be argued away or overcome simply. People still wonder about a woman who studied physics—not because they think she can’t do it—but because it is still so unusual,” says Dr. Sarah Biela, who holds a PhD in physics and leads BIOTRONIK’s team of marketing and product managers for electrophysiology products as Director of EP Product Management. “Women and men should have the courage to cooperate and approach each other.”Sofia Binias, who heads BIOTRONIK’s quality assurance team for pacemakers and defibrillators as a Senior Engineer, agrees. “I do think women experience different challenges than men. You need to assert yourself more to be heard.”Binias and Dr. Biela both note how the landscape for women in technical positions has made positive strides—both at BIOTRONIK and in MedTech in general. However, there are still steps to making the sector more supportive for women to advance.“I find it particularly noteworthy how in recent years, we’ve seen so may women take their places and earn respect in traditionally male departments like engineering, for example,” says Dr. Biela. She notes it’s important to be able to find role models and mentors across both industry and job function—whether in STEM fields or not—and from the factory floor to the C-Suite.“BIOTRONIK is endeavoring to promote more women, particularly in management roles. There are a few managers in particular who are working to increase the proportion of women in their teams and this is good. There are non-technical teams too where the ratio between women and men is virtually balanced,” adds Binias. BIOTRONIK’s Women in Leadership Network also helps women inside the company support each other in navigating questions around promotion and advancement.Promoting a Supportive Work EnvironmentWhile women should be encouraged to take initiative and assert themselves, organizations and companies also need to promote a supportive culture—where everyone has the common goal of ensuring that entire teams excel. “I have received most of my encouragement, all the way back to my studies, from men,” says Dr. Janine Broda, who heads up Manufacturing Production Operations for Active Implants at BIOTRONIK’s Berlin headquarters.Indeed, our panel notes how important it is for all employees to take on issues that perhaps in the past, were often thought to primarily affect women. For example, the question of how to balance work and family life continues to come up in discussions of how to help women advance. However, our panel suggests that more STEM-focused companies need to move further in treating work-life balance as an issue for the entire workplace in general.“In my view, family planning still has more professional consequence for women than for men. I was concerned about the conditions of which I could return to work after my daughters were born,” says Dr. Anke Topp, a trained chemist who leads a team that develops production and testing methods for BIOTRONIK stents. “As a positive trend though, I see more men taking longer parental leave or taking care of their sick children at home.”Encouraging Excellence at Work and at HomeCompanies can help the process by being proactive on issues of work-life balance, and making clear that arrangements like parental leave or part-time options are open to everyone. As an example, from 2011 to 2015, BIOTRONIK saw an eightfold increase in the number of men taking parental leave. Since then, the average amount of time men take parental leave has also gotten steadily longer.Philine Baumann-Zumstein, Manager of the Preclinical Affairs department at BIOTRONIK’s Vascular Intervention headquarters in Buelach, Switzerland, says women thinking of going into a scientific career should know they can have both. “This is not a decision to take for one OR the other. They both work together perfectly fine. I have met so many wonderful and extremely capable, scientifically brilliant moms. If anything, having your own kids will make science look easy and that intellectually challenging job will make you love to read that picture book for the hundredth time in a row,” she saysSo what can we learn for the future? Our panel tells us even companies that are on the right track can consistently reflect on their progress and make improvements. Establishing a supportive work environment is key, where all employees—men and women—respect and encourage each other. Helping all employees maintain a good work-life balance can also help advance women’s careers while still benefitting all employees. Finally, the importance of role models became clear. Many of the colleagues we interviewed have a management role at BIOTRONIK, and stressed that advancing the full potential of women in science, still requires more women to be present at the very top — across all departments, companies, and industries.

  • Your Heart is Still a Pandemic Priority: ESC Campaign Raises Concern Over Fewer Heart Attack Patients Seeking Care in Pandemic
    on February 23, 2021 at 8:10 am

    One thing our ongoing global pandemic hasn’t put on hold is the need to act early when providing emergency cardiovascular care. Heart attacks and strokes are still happening, even as it feels the world around us has slowed down. Heart researchers have spotted a few worrying trends in the last year when it comes to patients seeking emergency care after a heart attack or stroke. As medical doctors, that’s why it’s important for us to stress that seeking care as soon as possible during a cardiovascular emergency is crucial. Furthermore, providing care is still a top priority for us as physicians. When it comes to cardiovascular events like heart attacks and strokes, every minute counts.Are Patients Scared to Report Their Symptoms?Campaigns like the European Society of Cardiology’s Can’t Pause a Heart deserve our support given concerning data about emergency room visits for cardiovascular care. An extensive ESC survey of hospital professionals in 141 countries found that hospitals were admitting an average of 50 percent fewer patients for heart attacks than before the pandemic. This doesn’t mean heart attacks dropped by 50 percent, but likely means fewer patients were reporting their symptoms. This is especially so because, of those patients who did come in, survey respondents reported 48 percent had cases that were delayed beyond the optimal time window for care. The drop in hospital admissions raised alarms in the cardiology community, with doctors hypothesizing that patients were putting off going to the emergency room because they were afraid to contract COVID—19 at the hospital. These hypotheses appeared to have solid footing, when one study later found a higher incidence of “out of hospital” cardiac arrests at home.It’s a concerning trend many cardiologists started observing right from the very beginning of the pandemic. “Patients were anxious about going to the doctor even if they had [heart] symptoms,” Prof. Dr. Michael Haude, Director of the Heart and Vascular Center in Neuss, Germany told the triple-i virtual scientific meeting hosted by BIOTRONIK. “We saw patients coming later with infarctions being a few days old, where the whole situation is worse for the patient and for us to help them adequately.The ESC teamed up with the American College of Cardiology to urge patients not to put off going to the emergency room, while the Cleveland and Mayo clinic presidents co-authored a New York Times opinion piece telling patients that hospitals were still safe to go to in emergencies.What Should Patients Know and How Can Physicians Reassure Them?Similarly, the goal of the ESC campaign, and those who support it, is to help assure our patients that, amidst the pandemic’s stressors, seeking emergency medical care is still safe and encouraged. Heart health still matters, and it’s important that patients head to the emergency room as soon as possible after experiencing potential symptoms of a heart attack or stroke. A patient who gets early care during a cardiovascular event is not only more likely to survive, but is also less likely to have lasting damage. Symptoms may include:A burning or tight sensation in the chest that may also be felt in the arm, back, stomach, throat, jaw or neckSudden shortness of breathSometimes nausea or severe sweatingFor stroke: weakness in face, arm or leg, along with trouble speakingIf these last for any longer than five minutes, patients are advised to call an ambulance. Hospitals around the globe have implemented hygiene measures to enable safe emergency care, even during the pandemic. These measures have only improved as we learn more about the virus and how to prevent infections.Hospitals Are Pandemic-Prepared“We’re better prepared. We have masks and protective equipment everywhere,” Dr. Manel Sabate, Chief of Interventional Cardiology, at the Clinic University Hospital in Barcelona told the triple-i meeting. “We have kept normal activity and have not cancelled any other necessary procedures.”As physicians, we should bear in mind the degree of stress the pandemic has put our patients under, and do our best to reassure them that heart health is still a top priority.

  • How Do We Encourage More Talented Women and Girls into STEM Subjects & Jobs?
    on February 10, 2021 at 3:18 pm

    Despite being half the world’s population, women make up less than ten percent of students enrolled in subjects like statistics, mathematics, and engineering. At the same time, only about 30 percent of the world’s researchers are women. Recent UNESCO statistics also find women in STEM fields (science, technology, engineering and mathematics) publish less, are paid less for their research and do not progress as far in their careers as their male counterparts. Yet whether it is the first approved COVID—19 vaccine, the discovery of new elements like radium and polonium for cancer treatment, or understanding DNA structure—women have long been at the forefront of scientific breakthroughs. Developing scientific talent in girls, and helping women working in science advance in their careers are key parts of encouraging human innovation that helps tackle modern challenges.To this end, the United Nations General Assembly designated February 11 as the International Day of Women and Girls in Science to help spur the discussion about how to spot and develop such an untapped pool of promising scientific talent. To help mark the occasion, we asked six women working in challenging technical positions at BIOTRONIK about how they got into their fields and what advice they have for girls and young women thinking about a career in science. For several of them, having a supportive teacher or mentor early on was crucial.Early Mentorship Matters“It was actually my physics teacher who first got me excited about science in general. When it came time to decide what specialty to study, I remembered that math—the language of physics—always came easy to me. I found the logical approach to solving problems very attractive and I still use that approach in my job today,” says Dr. Sarah Biela, who leads BIOTRONIK’s team of marketing and product managers for electrophysiology products as Director of EP Product Management. “You don’t have to believe everything someone says, instead you can measure and analyze, and then see what the facts tell you.”“I had a great chemistry teacher who got me excited about the subject since my very first school lesson,” recalls Dr. Janine Broda, who heads up Manufacturing Production Operations for Active Implants at BIOTRONIK’s Berlin headquarters. “I made the decision early.”“I had a very inspirational chemistry teacher and he made me connect to science in general. However, once we had genetic engineering in our biology class, I knew that this is what I wanted to know more about,” says Philine Baumann-Zumstein, Manager of the Preclinical Affairs department at BIOTRONIK’s Vascular Intervention headquarters in Bülach, Switzerland.The importance of support early on motivated Sofia Binias, who leads BIOTRONIK’s quality assurance team for pacemakers and defibrillators as Senior Engineer, to get involved with Club Lise—a German mentoring program for high school students interested in a future scientific career. As part of the program, Binias has facilitated visits to BIOTRONIK for grade ten girls since 2012. “As a part of this project, these girls and young women can visit our company, talk with us and find out what we do every day,” explains Binias. “I like to help give them the courage to pursue studies in the sciences and show them where I work. It’s important young women discover their talents for science while still in school. That puts them on the way to making valuable contributions to science and industry.”Susanne Spintig, Director of the Club Lise mentoring program, outlines how important it is for young women to have the opportunity to visit their mentors at their workplaces. “It‘s not about emulating the mentors directly. Instead mentees reflect together with mentors on how careers, strategies and experiences can be adapted in order to find their own paths,” Spintig explains. “The professional reception from our BIOTRONIK mentors is something very special every year and lastingly impressive, with Club Lise alumni eventually going into internships and working student positions at BIOTRONIK.”Scientific Careers Begin with Scientific Curiosity and PassionAlthough early mentorship and exposure can make a huge difference, the women were quick to stress that the most important thing when thinking about a career in science is that it complements a personal interest. “Studying science opens up so many options and possibilities for future careers. That shouldn’t be the only reason to make that decision though,” argues Dr. Anke Topp, a trained chemist who leads a team that develops production and testing technologies for BIOTRONIK stents. “Far more important is your personal interest and passion for the sciences.”“Be curious, be bold and confident, but always keep questioning yourself. Pursue what awakens your inquisitive nature,” advises Baumann-Zumstein. “You will always have your dream job as long as you do what you love for as long as you love it.”Binias similarly says that the most important place to begin is with a love for science, with the rest eventually following from there. “You shouldn’t decide too quickly on a particular career, but instead take it step by step. Think about what scientific topics are fun for you and then study those,” she advises.“Stay curious and open and don’t be afraid to change your plan. Things often turn out differently. Don’t see that as failure, but rather as experience,” adds Dr. Broda. “Take the route that is the most fun and don’t let setbacks get you down.”Pay Attention to Other Skills TooFinally, girls and young women looking at a scientific career in the private sector should still keep an eye on business contexts.“If you want to work in industry, it’s a good idea to study something business-related in parallel, such as taking economics or business as a minor. Doing an internship or writing a thesis with a company also helps you see what companies are suitable for you, and what they’re offering,” says Dr. Petra Heerklotz, Director of Design Control & Risk Management at BIOTRONIK’s Vascular Intervention headquarters.“Soft skills like negotiation, communication and diplomacy are important too, especially for asserting your interests and promoting understanding. And then there’s teamwork. At BIOTRONIK, we always work as a team,” adds Sofia Binias.“I myself am a numbers, data and facts person—and these things play a big role at work,” says Dr. Broda. “But when it comes to developing employees and looking after work relationships, there’s an emotional element where facts, data and numbers can’t do much,” she argues.“Scientific know-how is often required but not everyone understands it. That’s why it’s really important to know how to explain complex issues to non-specialists,” says Dr. Biela.

  • BIOLUX AV Randomized Controlled Trial Demonstrates Safety and Efficacy of Passeo-18 Lux DCB in Treatment of Dysfunctional Hemodialysis Access
    on February 1, 2021 at 9:45 am

    Recent data from the investigator-initiated, randomized controlled trial (RCT), BIOLUX AV, showed that the treatment of patients with dysfunctional hemodialysis access (HA), with BIOTRONIK’s Passeo®-18 LuxTM drug-coated balloon (DCB)*, is safe and effectively prevents HA failure**.Patients (N = 120) with dysfunctional HA underwent initial high-pressure balloon angioplasty and were randomly assigned for a second angioplasty using either the Passeo-18 Lux DCB or a plain percutaneous transluminal angioplasty (PTA) balloon. Patients were initially followed-up for one year, and quantitative angiography was performed six months after angioplasty.The one-year data, presented by Prof. Eric Therasse at LINC 2021,1 the Leipzig Interventional Course, and published in the Journal of Vascular and Interventional Radiology,2 showed that, in comparison with uncoated balloon PTA, DCB angioplasty was associated with a significantly lower HA failure rate and need for reintervention.Serious adverse events related to HA were less frequent after DCB treatment than after plain PTA. The study principal investigator also stressed that this study, as with previous ones3,4 using DCBs in HA lesions, did not demonstrate a significant increase in mortality in the DCB group.Key results from the BIOLUX AV trial publication:At 12 months, the Kaplan-Meier patency estimate in the DCB arm was 62.6% vs 35.2% for the plain PTA group (P = 0.001).In comparison with plain PTA, DCB angioplasty was associated with significantly greater time to HA circuit failure (mean estimate [95% confidence interval], 267 vs 209 days; P = 0.009) and HA target lesion failure (mean estimate [95% confidence interval], 294 vs 218 days; P = 0.001).Serious adverse events related to HA were less frequent after DCB than after plain PTA.Survival after DCB and plain PTA were not significantly different at 12-month follow-up and through a median follow-up of approximately three years (1,103 days; P = 0.31). This is the only AV RCT reporting mortality data up to 3-year follow-up.“DCBs with paclitaxel have demonstrated variable results to prevent HA restenosis in a few RCTs, and, until recently, their effectiveness was unclear,” explained Prof. Eric Therasse, BIOLUX AV principal investigator and Professor at the Department of Radiology, Radio-Oncology and Nuclear Medicine at the University of Montreal, Canada. The study investigators hypothesized that differences in paclitaxel dosages and excipients of DCBs may be responsible for these variable results and that, in comparison to plain PTA, the paclitaxel-coated balloon technology used in the Passeo-18 Lux would significantly decrease the HA restenosis rate at the treated site.“Our results show the clinical benefit of DCBs to prevent hemodialysis access failure. Both hemodialysis access circuit and hemodialysis access target lesion failures were significantly reduced in the DCB group,” summarized Prof. Eric Therasse.“The BIOLUX AV study contributes to a growing body of evidence exploring Passeo-18 Lux, along with other DCBs improving the treatment of dysfunctional HA,” commented Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK.-END-Referenzen:1 Thérasse, É. Safety and efficacy of drug eluting balloon angioplasty of dialysis fistula: 12-month outcomes from a randomized clinical trial with Passeo-18 Lux. Presented at: LINC 2021. January 29, 2021.2. Thérasse, É, Caty V, Gilbert P, et al. Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone. J Vasc Interv Radiol. 2020; https://doi.org/10.1016/j.jvir.2020.10.030.3. Lookstein RA, Haruguchi H, Ouriel K, et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med. 2020; 383:733–742.4. Morena-Sánchez T, Moreno-Ramírez M, Machancoses FH, et al. Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomize trial. Cardiovasc and Interv Radiol. 2020;43:382-390.* Passeo-18 Lux is not indicated for the treatment of dysfunctional hemodialysis access. The Passeo-18 Lux catheter is indicated to dilate de novo or restenotic lesions in the infrainguinal arteries.** HA failure was defined as a composite endpoint of HA thrombosis, HA re-intervention (including creation of a new HA), or dialysis catheter insertion at 12 months.Passeo and Lux are trademarks or registered trademarks of the BIOTRONIK Group of Companies.